Microbiota-targeted interventions and clinical implications for maternal-offspring health: An umbrella review of systematic reviews and meta-analyses of randomised controlled trials.

Background: Microbes in the human body are the determinants of life-long health and disease. Microbiome acquisition starts in utero and matures during early childhood through breastfeeding. However, maternal gut dysbiosis affects the maternal-offspring microbiome interplay. Lines of evidence on dysbiosis-targeted interventions and their effect on maternal-offspring health and gut microbiome are inconsistent and inconclusive. Therefore, this study summarised studies to identify the most common microbiota-targeted intervention during pregnancy and lactation and to comprehensively evaluate its effects on maternal and offspring health. Methods: This umbrella review was conducted by systematically searching databases such as PubMed and the Web of Science from inception to 2 September 2023. The quality was assessed using the Assessment of Multiple Systematic Reviews-2 checklist. The Grading of Recommendations Assessment, Development, and Evaluation was used for grading the strength and certainty of the studies. The overlap of primary studies was quantified by the corrected covered area score. Results: A total of 17 systematic reviews and meta-analyses with 219 randomised controlled trials, 39 113 mothers, and 20 915 infants were included in this study. About 88% of studies had moderate and above certainty of evidence. Probiotics were the most common and effective interventions at reducing gestational diabetes risk (fasting blood glucose with the mean difference (MD) = -2.92, -0.05; I2 = 45, 98.97), fasting serum insulin (MD = -2.3, -2.06; I2 = 45, 77), glycated haemoglobin (Hb A1c) = -0.16; I2 = 0.00)), Homeostatic Model Assessment of insulin resistance (HOMA-IR) (MD = -20.55, -0.16; I2 = 0.00, 72.00), and lipid metabolism (MD = -5.47, 0.98; I2 = 0.00, 90.65). It was also effective in preventing and treating mastitis (risk ratio (RR) = 0.49; I2 = 2.00), relieving anxiety symptoms (MD = -0.99, 0.01; I2 = 0.00, 70.00), depression in lactation (MD = -0.46, -0.22; I2 = 0.00, 74.00) and reducing recto-vaginal bacterial colonisation (odds ratio (OR) = 0.62; I2 = 4.80), and with no adverse events. It also effectively remodelled the infant gut microbiome (MD = 0.89; I2 = 95.01) and prevented infant allergies. However, studies on pregnancy outcomes and preeclampsia incidences are limited. Conclusions: Our findings from high-quality studies identify that probiotics are the most common microbiome interventions during pregnancy and lactation. Probiotics have a strong impact on maternal and offspring health through maintaining gut microbiome homeostasis. However, further studies are needed on the effect of microbiota-targeted interventions on maternal cardiometabolic health, pregnancy, and neonatal outcomes. Registration: This umbrella review was registered with PROSPERO, CRD42023437098.

Supporting Carers: Study Protocol of a Meta-Review of Psychosocial Interventions for Carers of People With Cancer.

BACKGROUND: While there is a clear need for psychosocial interventions that promote the well-being of carers of patients with cancer, the corresponding evidence base is disparate, complex, and difficult for end users to navigate and interpret. Carers remain undersupported with a lack of dedicated, effective, evidence-based programs. We will conduct a meta-review to synthesize this evidence and determine the state of science in this field. OBJECTIVE: This study aims to address the question, "what psychosocial interventions are available to promote the well-being of carers for people with cancer?" METHODS: A meta-review will synthesize the relevant reviews of psychosocial interventions that have been developed and evaluated with carers for people with cancer. A total of 4 electronic databases (PsycInfo, MEDLINE, CINAHL, and Cochrane Database of Systematic Reviews) will be searched for reviews published between January 2013 and December 2023. A team-based approach will be taken for screening and assessment of the returned records against the eligibility criteria to determine inclusion. Included reviews will be critically appraised using the Joanna Briggs Institute Critical Appraisal Checklist for Systematic Reviews and Research Syntheses. Relevant data on study characteristics, carer and patient populations, intervention details, and psychosocial outcomes will be extracted, synthesized, and the findings will be presented in a narrative format. RESULTS: It is anticipated that the study will be completed by October 2024. CONCLUSIONS: Ensuring that carers have access to evidence-based programs that promote their well-being as they care for loved ones is critical. This meta-review will contribute to program development and translation efforts by providing a clear picture of the intervention evidence base of carers of patients with cancer and identifying notable strengths, weaknesses, and gaps across the literature. The findings are anticipated to offer future directions to advance research in the field. TRIAL REGISTRATION: PROSPERO (CRD42023403219); https://tinyurl.com/4tnzv49s. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56403.

Effectiveness of moisturising therapy in treating nipple trauma: a systematic review protocol.

INTRODUCTION: Breastfeeding is crucial in infant nutrition and bonding, recommended for at least 6 months and up to 2 years postpartum, providing health benefits for both infants and mothers. However, nipple trauma is common among lactating mothers. Moisturising therapies, such as hydrogel application, aim to promote the healing of nipple wounds. Despite various interventions proposed, comprehensive reviews evaluating the efficacy of moisturising therapies for nipple trauma are lacking. This review aims to appraise the effectiveness of moisturising therapy, particularly tailored for nipple trauma in lactating women. METHODS AND ANALYSIS: This systematic review protocol adheres to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines and is registered in the International Prospective Register of Systematic Reviews. The focus will be on both randomised and non-randomised controlled trials addressing the treatment of nipple trauma in lactating women. In this context, 'moisturising therapy' is categorised as a non-pharmacological intervention applied directly to the nipple, excluding treatments for bacterial or fungal infections. The primary outcomes will include measures of the healing efficiency of nipple trauma and reduction in nipple pain. Searches will be conducted without date restrictions across multiple databases, including PubMed, CINAHL, the Cochrane Library, Web of Science, CiNii Research and Ichushi-Web, in addition to exploration of grey literature. Two independent reviewers will manage all stages of the review process, under the supervision of a third reviewer. Data extraction will encompass participant demographics, study methodologies, sample specifics and measured outcomes. Quality assessment will be conducted using the Joanna Briggs Institute Appraisal Checklist Tools. ETHICS AND DISSEMINATION: Ethics approval is not required for this study. The findings of this review will be disseminated through academic publications, detailed reports and presentations at relevant conferences. PROSPERO REGISTRATION NUMBER: CRD42023481761.

Morphological changes in temporomandibular joint architecture in patients with temporomandibular disorders: systematic review protocol.

OBJECTIVE: The review involves the assessment of morphological variations in the temporomandibular joint (TMJ) and its associated structures in patients with temporomandibular disorder. INTRODUCTION: Temporomandibular disorders (TMD) are debilitating conditions that affect the TMJ complex, surrounding musculature and osseous components. Studies have reported that TMD result from morphological alterations in TMJ. These alterations can be efficiently studied using three-dimensional imaging. This review will summarise the morphological changes in TMJ and associated structures based on studies with three-dimensional imaging in patients with TMD. INCLUSION CRITERIA: The systematic review will include studies with adult subjects with any one symptom of TMD and those studies that assessed TMJ morphology using three-dimensional imaging like CT, cone beam CT, MRI or arthrography. METHODS: Systematic searches for relevant studies will be carried out in multiple databases. Sources will include MEDLINE, Scopus, Dentistry and Oral Sciences Source, Cochrane CENTRAL, CINAHL, Web of Science, ProQuest Dissertation and Thesis and Google Scholar. The databases will be searched from inception to November 2023. Analytical observational studies comprising retrospective and prospective cohort studies, case-control studies and analytical cross-sectional studies will be selected and critical appraisal will be performed. No restrictions will be imposed on the date and country of publication. Joanna Briggs Institute (JBI) guidelines for systematic effectiveness reviews will be followed for data appraisal, extraction and synthesis. The strength of evidence will be graded using the Grading of Recommendations, Assessment, Development and Evaluation method and the summary of findings will be created using GRADEpro software. ETHICS AND DISSEMINATION: Ethical approval is not applicable for this study since this involves analysis of secondary data. Results will be disseminated through peer-reviewed publications and cnference presentations. A comprehensive summary of morphological alterations in TMJ is essential for assessing risk factors, accurate diagnosis, treatment planning and will collectively contribute to enhanced clinical care and overall patient well-being. PROSPERO REGISTRATION NUMBER: The protocol is registered in PROSPERO: CRD42023448882.

Role of sex and training characteristics on exercise effects on cardiovascular aging: protocol for a systematic review with meta-analysis of randomized trials.

BACKGROUND: Cardiovascular diseases remain a leading global cause of mortality worldwide especially in older adults. Although it is known that regular exercise reduces cardiovascular diseases incidence, its effects on specific cardiovascular aging parameters considering the influence of sex and different exercise designs are still not fully understood. Therefore, this systematic review and meta-analysis aims to evaluate the effects of different physical exercise protocols on age-related cardiovascular outcomes in older adults. METHODS: This systematic review and meta-analysis will be reported in agreement with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Articles will be eligible if they are randomized controlled trials with a primary objective of evaluating the chronic effects of exercise interventions on cardiovascular aging parameters. Search strategy will be performed from the inception to September 30th, 2023, in the following electronic databases: MEDLINE (Ovid), SCOPUS (Elsevier), Embase, Sport Discus (EBSCO), Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science Core Collection (Clarivate Analytics). Data will be extracted and managed through Research Electronic Data Capture (REDCap) software. The Tool for the assEssment of Study qualiTy and reporting in EXercise (TESTEX) will be used to assess the methodological quality of included studies. Additionally, the quality of the findings will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) profiler. Meta-analysis based on the random-effects model will be performed (if deemed suitable, considering the methodological and clinical heterogeneity of the studies) to estimate the effects of exercise training on cardiovascular aging variables (i.e., cardiac output; arterial stiffness; stroke volume; endothelial function; and carotid intima-media thickness). Heterogeneity will be assessed with the I2 statistics, while the publication bias will be assessed based on Egger's test. DISCUSSION: To the best of our knowledge, this will be the first systematic review and meta-analysis to investigate the impact of sex and training protocols on the cardiovascular aging parameters. Moreover, the findings of this systematic review and meta-analysis will provide evidence for health professionals in the management of elderly patients in order to optimize the exercise prescription to face the cardiovascular alterations related to the aging process, considering the effects of different protocols according to sex. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42023441015 .

Prediction models for intradialytic hypotension in hemodialysis patients: A protocol for systematic review and critical appraisal.

Intradialytic hypotension (IDH) is common in hemodialysis patients and can lead to several complications. Risk factors for IDH include demographic characteristics, comorbidities, dialysis procedure factors, and so on. Clinical studies on predictive models for dialysis-induced hypotension have shown inconsistent results. This systematic review aims to evaluate published prediction models for IDH, analyzing their characteristics, predictors, efficacy, and the methodological quality and applicability. The protocol has been prepared using the Preferred Items for Systematic Review and Meta-analysis Protocols (PRISMA-P) guidelines. The systematic review protocol for IDH prediction in hemodialysis patients has been registered with the International Platform of Registered Systematic Review and Meta-analysis Protocols (INPLASY2023110081, DOI: 10.37766/inplasy2023.11.0081). A comprehensive search across five major databases (PubMed, Web of Science, Cochrane Library, CNKI, and Wanfang) will be conducted for studies on prediction models of IDH among hemodialysis patients. Two researchers will independently screen literature, extract data, and evaluate the bias risk and applicability of included studies using prediction modelling study tools. This systematic review will provide critical insights into the efficacy and quality of reporting of the IDH model in hemodialysis patients. This will guide clinical staff in selecting the most appropriate IDH prediction model and inform future research endeavors in IDH prediction.

Effects of cocoa consumption on cardiometabolic risk markers: Protocol for a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: Cardiometabolic diseases cover a spectrum of interrelated conditions linked to metabolic dysfunctions and/or cardiovascular disorders, including systemic arterial hypertension, diabetes mellitus, dyslipidemia, and obesity. Cocoa is a rich source of dietary polyphenols and has been associated with cardiovascular health benefits. However, beneficial effects of cocoa consumption and appropriate quantities in decreasing cardiometabolic risk factors have yet to be established. Therefore, we will conduct a systematic review and meta-analysis to examine the effects of cocoa consumption on cardiometabolic risk markers (total cholesterol, HDL, LDL, triglycerides, blood glucose, glycated hemoglobin, waist circumference, abdominal circumference, body mass index, systolic blood pressure and diastolic blood pressure) in adults with or without established cardiovascular risk factors. METHODS: Our review will include all randomized controlled trials published in English, Portuguese and Spanish with no date of publication restrictions evaluating the effects of cocoa consumption on cardiometabolic risk markers selected from the databases MEDLINE (PubMed), LILACS, Cochrane, EMBASE, Web of Science and SciELO, and gray literature. Eligible studies must involve adults (age ≥18y), and the consumption of cocoa or dark chocolate (≥ 70% cocoa), include a control group and evaluate blood pressure, anthropometric measurements, and lipid or glycemic profiles. We will use risk-of-bias 2 (RoB2) tool to assess the risk of bias and the GRADE system to assess the strength of evidence. Statistical analyses will be performed using RStudio for Windows and R package meta. DISCUSSION: This meta-analysis will summarize existing evidence on the effects of cocoa consumption on cardiometabolic health in adults. Better understanding the effects of cocoa consumption on anthropometric measurements, blood pressure, and lipid and glycemic profiles can provide valuable insights for health professionals to improve dietary recommendations regarding appropriate quantities. TRIAL REGISTRATION: Systematic Review Registration: PROSPERO CRD42023484490.

Health professionals' attitudes towards traditional healing for mental illness: A systematic review protocol.

BACKGROUND: Mental illness is a global problem that receives less attention, particularly in developing countries. Integrating modern treatment with traditional healing approaches has been proposed as one way to address mental health problems, especially in developing countries. Despite health professionals' participation in traditional healing being crucial to integrative approaches, their participation is limited to date. This review protocol is designed to explore the attitudes of health professionals towards traditional healing practices in mental health services. METHODS: The review will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guidelines. Searching databases, including PubMed/Medline, PsychINFO, EMBASE, Scopus, and the Web of sciences will be conducted. Additionally, Google and Google Scholar will be searched for other information, including grey literature. Moreover, a manual search of identified articles' reference lists will also be conducted to help ensure all potential papers are included in the review. Qualitative, quantitative, and mixed study methods published in English between January 2014 and April 2024 will be included. The qualities of the included studies will be assessed using the Mixed Methods Appraisal Tool (MMAT) Version 2018. A mixed-method synthesis will be used to synthesis the results. DISCUSSION: It is crucial for healthcare professionals to provide culturally sensitive care to empower people to manage their health. This systematic review will summarize the attitudes of health professionals towards the adoption and delivery of traditional healing approaches to people experiencing mental illness. Therefore, the findings of this review will support integration between traditional healers and modern mental health practitioners for the treatment of mental illness. TRIAL REGISTRATION: Protocol registration number: CRD42024535136.

Nursing staff's attitudes towards the prevention of adverse events among hospitalized people with dementia: Protocol of qualitative systematic review and evidence synthesis.

INTRODUCTION: People with dementia are more likely than people without dementia to be hospitalized and to experience in-hospital preventable adverse events, such as falls, skin injury, and infection, compared to other hospitalized groups. Negative attitudes towards people with dementia are common among acute healthcare workers and have been linked to a cascade of negative adverse events in this population. However, no qualitative systematic review has ever been conducted to synthesize the existing evidence in this area, which hampers the development of preventative measures. AIM: This is a protocol for a qualitative systematic review aimed at exploring and synthesizing existing qualitative evidence regarding the attitudes of nursing staff towards the prevention of adverse events among hospitalized people with dementia. METHODS: Literature searches will be performed in PubMed, CINAHL, PsycINFO, Web of Science, Biblioteca Virtual de Salud, Scopus, The Cochrane Library, and Google Scholar. The references of eligible studies will be checked for eligibility. All primary qualitative or mixed-methods studies with a qualitative component published in peer-reviewed academic journals in English, Portuguese, or Spanish will be eligible. There will be no limitations to the date of publication. The selection process will be conducted independently by two researchers using the software Rayyan and then compared and discussed. Any disagreements regarding eligibility will be discussed among the entire research team and resolved via consensus. Methodological quality will be assessed using Cochrane's guidance. A meta-aggregative approach will be employed to extract and synthesize the evidence using the software package QARI from the JBI. The confidence in the findings will be graded using ConQual. IMPLICATIONS: This review will help identify and better understand specific attitudinal and psychosocial aspects that influence nursing care delivery for people with dementia in hospital settings. Such data can be used to generate novel explanatory models of nursing behaviors in dementia care, as well as capacity building and training to enhance hospital care for people with dementia globally.

Major mistakes or errors in the use of trial sequential analysis in systematic reviews or meta-analyses - the METSA systematic review.

BACKGROUND: Systematic reviews and data synthesis of randomised clinical trials play a crucial role in clinical practice, research, and health policy. Trial sequential analysis can be used in systematic reviews to control type I and type II errors, but methodological errors including lack of protocols and transparency are cause for concern. We assessed the reporting of trial sequential analysis. METHODS: We searched Medline and the Cochrane Database of Systematic Reviews from 1 January 2018 to 31 December 2021 for systematic reviews and meta-analysis reports that include a trial sequential analysis. Only studies with at least two randomised clinical trials analysed in a forest plot and a trial sequential analysis were included. Two independent investigators assessed the studies. We evaluated protocolisation, reporting, and interpretation of the analyses, including their effect on any GRADE evaluation of imprecision. RESULTS: We included 270 systematic reviews and 274 meta-analysis reports and extracted data from 624 trial sequential analyses. Only 134/270 (50%) systematic reviews planned the trial sequential analysis in the protocol. For analyses on dichotomous outcomes, the proportion of events in the control group was missing in 181/439 (41%), relative risk reduction in 105/439 (24%), alpha in 30/439 (7%), beta in 128/439 (29%), and heterogeneity in 232/439 (53%). For analyses on continuous outcomes, the minimally relevant difference was missing in 125/185 (68%), variance (or standard deviation) in 144/185 (78%), alpha in 23/185 (12%), beta in 63/185 (34%), and heterogeneity in 105/185 (57%). Graphical illustration of the trial sequential analysis was present in 93% of the analyses, however, the Z-curve was wrongly displayed in 135/624 (22%) and 227/624 (36%) did not include futility boundaries. The overall transparency of all 624 analyses was very poor in 236 (38%) and poor in 173 (28%). CONCLUSIONS: The majority of trial sequential analyses are not transparent when preparing or presenting the required parameters, partly due to missing or poorly conducted protocols. This hampers interpretation, reproducibility, and validity. STUDY REGISTRATION: PROSPERO CRD42021273811.

Systematic review and meta-analysis of developmental assets scales: A study protocol for psychometric properties.

BACKGROUND AND AIMS: Application of developmental assets, one of existing Positive Youth Development (PYD) frameworks, has gained momentum in research, policy formulations, and interventions, necessitating the introduction of the most efficient scales for this framework. The present study protocol aims to conduct a systematic review and meta-analysis of developmental assets scales to document the underlying logic, objectives, and methodologies earmarked for the identification, selection, and critical evaluation of these scales. METHODS AND MATERIALS: In accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P), the intended search will encompass databases of PubMed, Scopus, Web of Knowledge, and PsycINFO, spanning from the inception of 1988 to 1st of April 2024. The review will include articles published published in English language focusing on individuals aged 10 to 29 years and reporting at least one type of reliability or validity of developmental assets scales. The review process will be in compliance with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN), and the overall quality of evidence will be determined using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) guidelines. DISCUSSION: This comprehensive assessment aims to identify potential biases in prior research and offer guidance to scholars regarding the optimal scales for developmental assets in terms of validity, reliability, responsiveness, and interpretability The evidence-based appraisal of the scales strengths and limitations is imperative in shaping future research, enhancing their methodological rigor, and proposing refinements to existing instruments for developmental assets.

Efficacy of perioperative pain management in paediatric cardiac surgery: a protocol for a network meta-analysis.

INTRODUCTION: Congenital heart disease is a common birth defect, but advancements in diagnosis and treatment have improved survival rates. Enhanced recovery after surgery (ERAS) programmes have emerged in paediatric cardiac surgery. Multimodal pain management, as a vital part of ERAS programmes, has been found to be effective in reducing pain and improving outcomes in cardiac surgery patients. Traditional methods of pain control using high-dose opioids can lead to complications, so nonopioid analgesics and regional anaesthesia techniques are being used to reduce the consumption. However, there is a significant variability in pain management practices in paediatric cardiac surgery. A network meta-analysis (NMA) is needed to comprehensively compare the effects of different analgesic interventions in this population. METHODS AND ANALYSIS: A comprehensive electronic literature database search will be performed using electronic databases, mainly including PubMed, EMBASE, Web of Science and Cochrane Central Register of Controlled Trials. All randomised controlled trials associated with perioperative pain management for paediatric cardiac surgery will be included. The primary outcome will be visual analogue score or numeric rating scale of pain and total opioid consumption (or equivalent) 24 hours after postoperative tracheal extubation. The Revised Cochrane Risk of Bias Tool will be employed to assess the quality of included articles. A random-effects pairwise meta-analysis will be performed to report the head-to-head comparison. Following the assessment of individual articles, an NMA will be conducted using a Bayesian framework with random-effects' models. ETHICS AND DISSEMINATION: Ethics approval is not necessary because this study will be based on publications. The results of this study will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42023477520.

Effect of prehabilitation for patients undergoing gastric cancer surgery: a protocol of a systematic review and meta-analysis.

INTRODUCTION: Gastric cancer is a high-risk cancer with surgical treatments often leading to significant postoperative complications and mortality. Prehabilitation, involving exercise, nutrition and psychological support before surgery, aims to boost patients' physical and mental health. While effective in other cancers, its benefits for gastric cancer need further study. This research will evaluate the impact of trimodal prehabilitation on patient outcomes in gastric cancer surgery, aiming to reduce complications and expedite recovery. METHODS AND ANALYSIS: This study will systematically review randomised controlled trials and cohort studies evaluating the role of prehabilitation in people undergoing gastric cancer resection. The primary outcomes of interest will include overall postoperative complications and length of hospital stay. The secondary outcomes of interest will include mortality, readmission rate or functional recovery. Databases including PubMed, EMBASE, CINAHL, CENTRAL, Chinese BioMedical Literature Database (CBM), Chinese National Knowledge Infrastructure (CNKI), Wanfang database and Chinese Science and Technology Periodicals (VIP) will be searched. All studies will be screened and selected using the criteria described in 'population, intervention/exposure, comparison, outcome and study design' format. Two independent reviewers will screen studies for relevance and methodological validity. Data from included studies will be extracted through a customised, preset data extraction sheet. The Cochrane Review Manager (V.5.3, Nordic Cochrane Centre, Copenhagen, Denmark) software will be used to perform the meta-analysis. ETHICS AND DISSEMINATION: Ethics approval is not required for this study as all results will be based on published papers. No primary data collection will be needed. Study findings will be presented at scientific conferences or published in a peer-reviewed scientific journal. PROSPERO REGISTRATION NUMBER: CRD42023488469.

Comparative effects of sacubitril/valsartan and ACEI/ARB on endothelial function and arterial stiffness in patients with heart failure: a protocol for systematic review and meta-analysis.

INTRODUCTION: Heart failure (HF) is a complex syndrome that affects millions of people worldwide and leads to significant morbidity and mortality. Sacubitril/valsartan, a combination drug consisting of a neprilysin inhibitor and an angiotensin receptor blocker (ARB), has shown a greater improvement in the prognosis of HF than ACE inhibitors (ACEI) or ARB. Recent studies have found that ACEI/ARB or sacubitril/valsartan can increase flow-mediated dilation (FMD) and reduce pulse wave velocity (PWV), which are independent predictors of cardiovascular events and HF prognosis. The purpose of this study is to assess and compare the effect of sacubitril/valsartan and ACEI/ARB on FMD and PWV using meta-analysis and further provide a reference for the role of sacubitril/valsartan in the treatment of HF. METHODS AND ANALYSIS: Clinical randomised controlled trials investigating the effect of sacubitril/valsartan and/or ACEI/ARB on FMD and PWV in patients with HF will be searched in the relevant database, including PubMed, Web of Science, Embase, Cochrane Library and China's National Knowledge Infrastructure up to January 2024. The outcomes of interest are changes in endothelial function assessed by FMD and changes in arterial stiffness assessed by PWV. The risk of bias was evaluated using the revised Cochrane risk of bias tool for randomised trials (RoB2.0). Review Manager V.5.3 software is used for meta-analysis data synthesis, sensitivity analysis, meta-regression analysis, subgroup analysis and risk of bias assessment. The reporting bias of studies will be evaluated using the funnel plot, in which symmetry will be assessed by Begg's and Egger's tests. The evidence quality of the included studies will be evaluated by the Grading of Recommendations Assessment, Development, and Evaluation. ETHICS AND DISSEMINATION: This study only analyses research data from the published literature and therefore does not require ethical approval. We will submit the systematic review to a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42024538148.

Arterial stiffness after 6 weeks postdelivery in women with a history of hypertensive disorders of pregnancy: a systematic review protocol.

INTRODUCTION: Hypertensive disorders of pregnancy (HDP) are one of the leading causes of maternal morbidity and mortality. The risk of developing cardiovascular diseases following HDP is high. Arterial stiffness is a prognostic indicator for cardiovascular disease in the general population, and it is elevated during pregnancy in women with HDP. No systematic reviews have been conducted to determine if arterial stiffness remains elevated beyond puerperium in these women with HDP. METHODS AND ANALYSIS: We will conduct a systematic literature search in the following electronic databases: Medline, PubMed, Embase, Cochrane Library, Google Scholar, Web of Science and CINAHL. The review will consider studies that investigate arterial stiffness in women who had HPD and are between 43 days and 10 years postdelivery and under 60 years of age. This systematic review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols guidelines. Estimates of mean ± SD for arterial stiffness indices (cfPWV, AIx and AIx@75) for the women in the included studies will be obtained. For studies where the estimates were reported as the median and IQR, approximate estimates of mean ± SD will be calculated by using the low and high end of the range, median and sample size. Data from the individual studies will be pooled by use of a random-effects model. The risk of bias assessment will be assessed using the Cochrane Collaboration tool and the Newcastle-Ottawa Quality Assessment Scale as appropriate. Sources of heterogeneity will be explored by sensitivity and subgroup analyses. ETHICS AND DISSEMINATION: No ethics approval is required as only published data will be used in this study. The research study's outcomes will be shared through scientific conferences and peer-reviewed publications. PROSPERO REGISTRATION NUMBER: CRD42023461867.

Stated preferences of adolescents and young adults for sexual and reproductive health services in Africa: a systematic review protocol.

BACKGROUND: Adolescence and young adulthood are critical life stages with varied healthcare needs. Adolescents and young adults (AYAs) are often confronted with challenges in their sexual and reproductive health (SRH) and rights. Uptake of SRH services among AYAs groups remains limited, especially in resource-limited settings. This could be partly attributed to the existing services not catering for the preferences of AYAs. However, there is no systematic evaluation of research to explore the preferences of AYAs for SRH services in Africa. Therefore, the objective of this systematic review is to assess AYAs's preferences for SRH in Africa. METHODS AND ANALYSIS: The systematic review will follow the recommendations of Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2020. Stated preference studies in the area of SRH services conducted among AYAs will be included. We will search MEDLINE, EMBASE, PsycINFO, CINAHL, Scopus, Global Health and Google Scholar databases. Two independent researchers will screen the articles, and any disagreement will be handled through discussion with the broader research team. The quality of the included papers will be assessed and reported. The preferences for attributes, the most important and least important attributes and preference heterogeneity will be reported. In addition, the preference research gap across African regions and SRH services among AYAs will be reported. ETHICS AND DISSEMINATION: Ethical approval is not required for this protocol. The systematic review findings will be published in a peer-reviewed journal and presented at conferences. PROSPERO REGISTRATION NUMBER: CRD42023386944.

Effect of ketogenic diets on lipid metabolism in adults: protocol for a systematic review.

INTRODUCTION: The ketogenic diet is a very low carbohydrate diet known for its ability to reduce weight and counteract hyperglycaemia. However, ketogenic diets recommend an increased intake of fats, raising concerns about cardiometabolic risk in adults. Due to the higher intake of fats in the ketogenic diet, there is significant variability in outcomes of lipid metabolism in the population. Interventions have reported improvements in lipid profile while other studies did not find changes, and there are reports of increased low density lipoprotein (LDL) and triglyceride values. Hence, this is a protocol for a systematic review of the published literature and a summary of the effect of ketogenic diets on lipid metabolism in adults. METHODS AND ANALYSIS: Five databases (PubMed, Embase, Scopus, Cochrane Library and Web of Science) will be searched for studies on ketogenic diets in adult populations. Studies will be included if they report results from ketogenic diet interventions among adults. Exclusion is populations with diagnosed neurological disorders. Two reviewers will independently screen retrieved citations, extract data and appraise the risk of bias. Quantitative estimates (eg, standardised mean difference) measuring the change in the total cholesterol, LDL and triglyceride concentration will be pooled using random effects meta-analysis to produce one summarised weighted estimate. Sources of heterogeneity will be explored using subgroup analysis. This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis for Protocols (PRISMA), and the final review will be reported following the PRISMA 2020 guidelines. ETHICS AND DISSEMINATION: The present protocol and the systematic review to be carried out do not require ethics clearance. The data source will be published studies. This review will provide estimates to inform the public about the effect of ketogenic diets on lipid metabolism and the possible peril of increasing cardiometabolic risk. The results will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42022309665.

[Human vs. ChatGPT. Is it possible obtain comparable results in the analysis of a scientific systematic review?] / Human vs ChatGPT. È possibile ottenere risultati paragonabili nell'analisi di scientific systematic review?

INTRODUCTION: There is growing interest in the use of ChatGPT in the writing and reviewing of scientific articles. In line with the nature of ChatGPT, we tested its effectiveness in the scientific article review process. METHODS: We compared the findings of a systematic review of the published literature, produced by researchers in the traditional way, with a version created by ChatGPT, obtained by providing the same inputs as the original paper and a set of instructions (prompts) optimized to obtain the same type of result; we also identified the process that led to a comparable result. In order to assess the effectiveness of ChatGPT in analyzing the systematic review, we selected an existing, replicable study on the experience of health care professionals in the use of digital tools in clinical practice, from which we extracted and downloaded the related 17 publications in Pdf format. Subsequently, we uploaded these references into ChatGPT, setting specific prompts detailing the professional profile required, the context of the application, the expected outputs, and the level of creative freedom (temperature) to a minimum to limit the possibility of "hallucinations". After verifying ChatGPT's understanding of the task, we performed several iterations of the prompt until we obtained a result comparable to the original review. Finally, we systematically compared the results obtained by ChatGPT with those of the reference review. RESULTS: The analysis showed that ChatGPT's results are comparable to human results, although 4 iterations of the prompt are required to approach the human benchmark. DISCUSSION: Although ChatGPT showed comparable capabilities in text review, human authors exhibited greater analytical depth in interpretation. Due to their greater creative freedom, the authors offered more details about the benefits of digital tools in the hospital setting. ChatGPT, however, enriched the analysis by including elements not contemplated initially. The final comparison revealed comparable macro-themes between the two approaches, emphasizing the need for careful human validation to ensure the full integrity and depth of the analysis. CONCLUSIONS: Generative artificial intelligence (AI), represented by ChatGPT, showed significant potential in revolutionizing the production of scientific literature by supporting healthcare professionals. Although there are challenges that require careful evaluation, ChatGPT's results are comparable to human results. The key element is not so much the superiority of AI over humans but the human ability to configure and direct AI for optimal or even potentially superior human results.

Psychological interventions for early-phase schizophrenia: protocol for a systematic review and network meta-analysis.

Introduction: Treating the early phase of schizophrenia is crucial for preventing further episodes and improving quality of life, functioning, and social inclusion. Pharmacotherapies are first-line treatments, but have limitations. There is consensus on the need for non-pharmacological interventions for individuals in the early phase of schizophrenia. Several psychological interventions have shown promising effects; however, their comparative effectiveness remains largely unknown. To address this issue, a network meta-analysis will be performed. We aim to develop a hierarchy of existing psychological treatments concerning their efficacy and tolerability, which will inform treatment guidelines. Protocol: Randomized controlled trials (RCTs) investigating psychological interventions for first-episode psychosis, first-episode schizophrenia, or early phase schizophrenia will be included. The primary outcome will be overall schizophrenia symptoms (measured up to 6 and 12 months, and at the longest follow-up) and relapse as a co-primary outcome. Secondary outcomes are premature discontinuation; change in positive, negative, and depressive symptoms of schizophrenia; response; quality of life; overall functioning; satisfaction with care; adherence; adverse events; and mortality. The study selection and data extraction are performed by two independent reviewers. We will assess the risk of bias of each study using the Cochrane Risk of Bias tool 2 and evaluate the confidence in the results using Confidence in Network Meta-Analysis (CINeMA). Subgroup and sensitivity analyses will be conducted to explore heterogeneity and assess the robustness of our findings. Discussion: This systematic review and network meta-analysis aims to compare multiple existing psychological interventions, establishing which are best for symptom reduction, relapse prevention, and other important outcomes in early phase schizophrenia. Our results may provide practical guidance concerning the most effective psychological intervention to reduce symptom severity and the societal burden associated with the disorder.

The impact of chiropractic care on prescription opioid use for non-cancer spine pain: protocol for a systematic review and meta-analysis.

BACKGROUND: In recent studies, receipt of chiropractic care has been associated with lower odds of receiving prescription opioids and, among those already prescribed, reduced doses of opioids among patients with non-cancer spine pain. These findings suggest that access to chiropractic services may reduce reliance on opioids for musculoskeletal pain. OBJECTIVE: To assess the impact of chiropractic care on initiation, or continued use, of prescription opioids among patients with non-cancer spine pain. METHODS: We will search for eligible randomized controlled trials (RCTs) and observational studies indexed in MEDLINE, Embase, AMED, CINAHL, Web of Science, and the Index to Chiropractic Literature from database inception to June 2024. Article screening, data extraction, and risk-of-bias assessment will be conducted independently by pairs of reviewers. We will conduct separate analyses for RCTs and observational studies and pool binary outcomes (e.g. prescribed opioid receipt, long-term opioid use, and higher versus lower opioid dose) as odds ratios (ORs) with associated 95% confidence intervals (CIs). When studies provide hazard ratios (HRs) or relative risks (RRs) for time-to-event data (e.g. time-to-first opioid prescription) or incidence rates (number of opioid prescriptions over time), we will first convert them to an OR before pooling. Continuous outcomes such as pain intensity, sleep quality, or morphine equivalent dose will be pooled as weighted mean differences with associated 95% CIs. We will conduct meta-analyses using random-effects models and explore sources of heterogeneity using subgroup analyses and meta-regression. We will evaluate the certainty of evidence of all outcomes using the GRADE approach and the credibility of all subgroup effects with ICEMAN criteria. Our systematic review will follow the PRISMA statement and MOOSE guidelines. DISCUSSION: Our review will establish the current evidence informing the impact of chiropractic care on new or continued prescription opioid use for non-cancer spine pain. We will disseminate our results through peer-reviewed publication and conference presentations. The findings of our review will be of interest to patients, health care providers, and policy-makers. TRIAL REGISTRATION: Systematic review registration: PROSPERO CRD42023432277.