Efficacy and safety of pembrolizumab in cervical cancer: Protocol for systematic review and meta-analysis of randomized clinical trials.

PURPOSE: This paper reports a systematic review and meta-analysis protocol that will be used to evaluate the efficacy and safety of pembrolizumab, alone or combined with bevacizumab and other therapies, in adult women with cervical carcinoma from stage IB2 onwards. METHODS: The protocol follows PRISMA-P recommendations and was registered on PROSPERO (CRD42024531233). The search will be conducted without restrictions on language and year of publication in the following databases: Pubmed, Embase, Scopus, Web of Science, Cancerlit, The World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) and Clinical Trials Registry Platform. Grey literature will be searched using the following sources: Clinicaltrials.gov, Google Scholar and Opengrey. Manual search will be carried out for the reference lists of eligible studies. The studies will be selected independently by two reviewers and all completed or ongoing randomized clinical trials that evaluated the efficacy and safety of pembrolizumab, used alone or combined with chemotherapy, radiotherapy, bevacizumab or surgery, in adult women diagnosed with cervical cancer, will be included. The data extraction will include population characteristics, type of treatment and main outcomes of studies. The methodological quality of the studies will be assessed using the Cochrane Risk of Bias 2.0. The certainty of the evidence will be rated using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE). CONCLUSIONS: The findings will be presented in narrative summary tables and a quantitative synthesis will be conducted using the 'meta' package of R software, version 4.3.1. This future systematic review may contribute with quality evidence for clinical decision-making on the use of pembrolizumab in women with cervical cancer.

Botulinum toxin for the management of bruxism: an overview of reviews protocol.

INTRODUCTION: Bruxism is characterised by a repetitive activity in the masticatory muscles that involves teeth clenching or grinding and/or forceful mandibular movements. Its management is typically initiated when individuals start experiencing the adverse effects of the condition. One of the available intervention forms is the administration of botulinum toxin type A (BoNT-A). Numerous systematic reviews have addressed the use of BoNT-A to manage bruxism; however, the results are controversial. The current overview aims to determine BoNT-A's effectiveness for managing bruxism in relation to placebo, the absence of treatment or alternative interventions in the adult population. METHODS AND ANALYSIS: This study will include systematic reviews (SRs), with or without meta-analysis, aiming to evaluate the efficacy of BoNT-A for bruxism in adults. A broad literature search will be carried out on Cochrane Library, EMBASE, LILACS, Livivo, PubMed/MEDLINE, Scopus, Web of Science and the grey literature. Experts in the topic and reference lists of included SRs will also be consulted. The study selection will be conducted in two phases by two independent reviewers. Data collection will be performed by one author and cross-checked by another. The methodological quality of included SRs will be evaluated using AMSTAR-II. A narrative synthesis will be employed as the formal method to combine individual study data. The overlap across studies will be quantified by the corrected covered area and illustrated by the Graphical Representation of Overlap for Overviews. ETHICS AND DISSEMINATION: This overview does not require ethics approval, as it uses secondary data from previously published studies. The results will be disseminated through the publication in a high-impact journal. OSF OF REGISTRATION: DOI: 10.17605/OSF.IO/RB45T.

Mindfulness-Based Cognitive Therapy for Treatment-Resistant Depression: A protocol for systematic review and meta-analysis.

BACKGROUND: Major Depressive Disorder (MDD) is a global health issue, and a significant portion of individuals with MDD experience Treatment-Resistant Depression (TRD), characterized by the lack of response to adequately trialed antidepressant medication and therapy. This systematic review aims to investigate the effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) as an intervention for individuals with TRD. MATERIALS AND METHODS: We will conduct a thorough search for publications of randomized clinical trials and quasi-experimental studies in MEDLINE, Embase, PsycINFO, Web of Science databases, and ClinicalTrials.gov. Furthermore, reference lists of included studies will be manually screened for additional relevant articles, with no restrictions on language or publication date. The search will be conducted from the inception of the databases until June 2024. Our PICO-guided research questions are: (1) In adults with Treatment-Resistant Depression, is MBCT more effective than standard care or other active treatments in reducing depressive symptoms? (2) In adults with Treatment-Resistant Depression, does MBCT demonstrate a comparable safety profile to standard care or other active treatments? The quality of the included studies will be assessed independently using the Cochrane Risk of Bias Tool (RoB 2). This study seeks to evaluate the effectiveness and tolerability of Mindfulness-Based Cognitive Therapy as an intervention for Treatment-Resistant Depression, and will employ the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) methodology to appraise the confidence in the evidence. PROSPERO REGISTRATION: Prospero registration ID: CRD42023411978. Registered on April 07, 2023.

Auricular Therapy to Control Pain in Women With Breast Cancer: Protocol for Systematic Review and Meta-Analysis.

BACKGROUND: The increased incidence of breast cancer implies the appearance of frequent symptoms associated with disease and treatments, such as pain. For the management of this issue, auricular therapy has been used in a complementary manner, especially for its safety and analgesic action. OBJECTIVE: This systematic review aims to summarize available evidence on the effects of auricular therapy on pain in women undergoing breast cancer treatment. METHODS: This is a systematic review that includes randomized controlled trials that evaluated the effects of auricular therapy on pain in women with breast cancer, as compared with other interventions (sham or placebo auricular therapy, other nonpharmacological interventions, and routine pain treatments) during the treatment of the disease. Pain, whether induced or not by cancer treatments, is the main outcome to be evaluated. The search for the studies was performed in the following databases: MEDLINE through PubMed, CINAHL, CENTRAL, Embase, Web of Science, Scopus, VHL, TCIM Americas Network, CNKI, and Wanfang Data. The reviewers have independently evaluated the full texts, and in the near future, they will extract the data and assess the risk of bias in the included studies. The certainty of the evidence will be assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE), and a meta-analysis will be carried out to evaluate the intervention, considering the homogeneity of the results, using the Cochran Q test and quantified by the Higgins inconsistency index. The guidelines of the PRISMA-P (Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols) have been respected in the elaboration of this protocol. RESULTS: The records screening stage has been completed, and the synthesis and meta-analysis were conducted in February 2024. We hope to have finished the preparation of the paper for publication by September 2024. Review reporting will follow standard guidelines for reporting systematic reviews. The results will be published in peer-reviewed scientific journals. CONCLUSIONS: This review will compile the strength of evidence for the use of auricular therapy in the management of pain in women with breast cancer during the treatment of the disease, identifying gaps in the available evidence as well as assisting health professionals in indicating the intervention for clinical practice. TRIAL REGISTRATION: PROSPERO CRD42022382433; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=382433. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55792.

Mapping the evaluation of the electronic health system PEC e-SUS APS in Brazil: a scoping review protocol.

BACKGROUND: The Brazilian Ministry of Health has developed and provided the Citizen's Electronic Health Record (PEC e-SUS APS), a health information system freely available for utilization by all municipalities. Given the substantial financial investment being made to enhance the quality of health services in the country, it is crucial to understand how users evaluate this product. Consequently, this scoping review aims to map studies that have evaluated the PEC e-SUS APS. METHODS: This scoping review is guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) framework, as well as by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Checklist extension for scoping reviews (PRISMA-ScR). The research question was framed based on the "CoCoPop" mnemonic (Condition, Context, Population). The final question posed is, "How has the Citizen's Electronic Health Record (PEC e-SUS APS) been evaluated?" The search strategy will be executed across various databases (LILACS, PubMed/MEDLINE, Scopus, Web of Science, ACM Digital Library, and IEEE Digital Library), along with gray literature from ProQuest Dissertation and Theses Global and Google Scholar, with assistance from a professional healthcare librarian skilled in supporting systematic reviews. The database search will encompass the period from 2013 to 2024. Articles included will be selected by three independent reviewers in two stages, and the findings will undergo a descriptive analysis and synthesis following a "narrative review" approach. Independent reviewers will chart the data as outlined in the literature. DISCUSSION: The implementation process for the PEC e-SUS APS can be influenced by the varying characteristics of the over 5500 Brazilian municipalities. These factors and other challenges encountered by health professionals and managers may prove pivotal for a municipality's adoption of the PEC e-SUS APS system. With the literature mapping to be obtained from this review, vital insights into how users have evaluated the PEC will be obtained. SYSTEMATIC REVIEW REGISTRATION: The protocol has been registered prospectively at the Open Science Framework platform under the number 10.17605/OSF.IO/NPKRU.

Virtual clinical simulation as a paedagogical strategy in healthcare learning: Evidence and Gap Map protocol.

INTRODUCTION: Virtual clinical simulation involves creating and applying scenarios using technology like computers or virtual reality. This method provides a secure experiential learning environment, encouraging active student participation and stimulating clinical, critical and reflective thinking. This article outlines the development of the Evidence and Gap Map, which aims to identify, quantify and visually and interactively classify existing systematic reviews on the effectiveness of virtual clinical simulations in health professional training. METHODS AND ANALYSIS: The Evidence and Gap Map will adhere to the Campbell Collaboration Guidelines. Bibliographic searches in six databases will follow inclusion criteria determined by the Population, Intervention, Comparison, Outcome and Study design strategy. After the initial calibration, two reviewers will independently apply the inclusion and exclusion criteria to the title and abstract of each identified study, with subsequent full reading of the selected articles. The methodological quality of the included systematic reviews will be assessed with the AMSTAR 2 tool. The map will be developed using the EPPI-Mapper software. ETHICS AND DISSEMINATION: There is no requirement for ethical approval for this systematic review. On completion, it will be published in a peer-reviewed academic journal and presented at a conference. This review protocol was registered on the Open Science Framework platform (OSF Associated Project Registration: osf.io/r6wdc and received the following DOI: 10.17605/OSF.IO/R6WDC).

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.

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.

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 .

Development of a core outcome set for maternal and perinatal health research and surveillance in light of emerging and ongoing epidemic threats.

Background: Maternal and perinatal health is often directly and indirectly affected during infectious disease epidemics. Yet, a lack of evidence on epidemics' impact on women and their offspring delays informed decision-making for healthcare providers, pregnant women, women in the post-pregnancy period and policy-makers. To rapidly generate evidence in these circumstances, we aim to develop a Core Outcome Set (COS) for maternal and perinatal health research and surveillance in light of emerging and ongoing epidemic threats. Methods: We will conduct a Systematic Review and a four-stage modified Delphi expert consensus. The systematic literature will aim to inform experts on outcomes reported in maternal and perinatal research and surveillance during previous epidemics. The expert consensus will involve two individual, anonymous online surveys to rate outcomes' importance and suggest new ones, one virtual meeting to discuss disagreements, and one in-person meeting to agree on the final COS, outcomes definitions and measurement methods. Four panels will be established to participate in the modified Delphi with expertise in (a) maternal and perinatal health, (b) neonatal health, (c) public health and emergency response, and (d) representation of civil society. We will recruit at least 20 international experts for each stakeholder group, with diverse backgrounds and gender, professional, and geographic balance. Only highly-rated outcomes (with at least 80% of ratings being 7-9 on a 9-point Likert scale) and no more than 10% of low ratings (1-3) will be included in the final COS. Conclusions: Implementing this COS in future maternal and perinatal research and surveillance, especially in the context of emerging and ongoing epidemic threats, will facilitate the rapid and systematic generation of evidence. It will also enhance the ability of policy-makers, healthcare providers, pregnant women and women in the post-pregnancy period and their families to make well-informed choices in challenging circumstances.

Zinc and thyroid cancer: A systematic review and meta-analysis protocol.

INTRODUCTION: The thyroid cancer has the ninth larger incidence of cancer in the world. Investigations related to the exposure to metals have become important due to the sensibility of the thyroid gland to them. Studies reveal that carcinogenic progressions are associated to the deficiency of the essential trace elements. In this context, the zinc is highlighted, essential for the metabolism of the thyroidal hormone and has a potential relation with the pathogenesis of the thyroid cancer. The objective of this systematic review and meta-analysis is to evaluate the low serum zinc as a risk factor for thyroid cancer in adults. METHODS AND ANALYSIS: PubMed/MEDLINE, Scopus, Embase and LILACS databases will be searched for observational studies investigating the low serum zinc as a risk factor for thyroid cancer in adults. No language or publication period restrictions will be imposed. The primary outcome will be that the low serum zinc is a risk factor for thyroid cancer. Three independent reviewers will select the studies and extract data from the original publications. The risk-of-bias will be assessed by using the Newcastle-Ottawa Quality Assessment Scale (NOS). Data synthesis will be performed using the R software (V.4.3.1) and to assess heterogeneity, we will compute the I2 statistic and the results will be based on either random-effects or fixed-effects models, depending on the heterogeneity. The Grading of Recommendations, Development, and Evaluation (GRADE) system will be used to evaluate the reliability and quality of evidence. PROSPERO REGISTRATION NUMBER: International Prospective Register of Systematic Reviews (PROSPERO) CRD42023463747.

Is the use of Pentoxifylline and Tocopherol effective in the treatment of Osteoradionecrosis of the jaws or for the treatment of medicationosteonecrosis of the jaw? An overview.

PURPOSE: The aim of the present study was to determine the methodological quality of systematic reviews that evaluated the effectiveness of pentoxifylline and tocopherol (PENTO) in the treatment of osteoradionecrosis of the jaw (ORNJ) and medication-related osteonecrosis of the jaw (MRONJ). METHODS: Searches were performed in Databases including PubMed, Scopus, LILACS, DARE, Cochrane Library, and SIGLE through OpenGrey until March 2024, were evaluated by two independent reviewers to answer the following question: Is the use of PENTO protocol effective in the treatment of ORNJ or for the treatment of MRONJ? RESULTS: A total of 256 articles were initially identified; however, following the use of appropriate inclusion and exclusion criteria, five systematic reviews were identified for detailed analysis. The final study sample comprised 588 patients: 397 patients with ORN and 197 patients with MRONJ who were treated with PENTO. The total recovery of individuals who used the PENTO protocol was 62,2 % for ORN and 100 % for MRONJ, with a follow-up period of 1 month to 10 years. The methodological quality of the studies was assessed using the AMSTAR 2 tool, in which four were of low quality and 1 moderate quality. CONCLUSION: The treatment of ORN and MRONJ with pentoxifylline and tocopherol has shown good results in the studies presented, with a partial or total reduction in bone exposure. However, the low quality of the relevant reports highlights the need for primary and secondary studies with better methodological rigor to reduce bias and provide reassurance for this treatment option.

Effects of Different Exercise Interventions on Cardiorespiratory Fitness, as Measured by Peak Oxygen Consumption in Patients with Coronary Heart Disease: An Overview of Systematic Reviews.

BACKGROUND: Exercise is an important component of rehabilitation care for people with coronary heart disease (CHD). OBJECTIVES: The aim of this study was to critically analyze and summarize the existing evidence from published systematic reviews (SRs) and meta-analyses of randomized controlled trials (RCTs) that have evaluated the effects of different types of exercise interventions on cardiorespiratory fitness, as measured by peak oxygen consumption in people with CHD. METHODS: Electronic databases (Cochrane Library, Medline/PubMed, EMBASE, and PEDro) were searched for SRs of exercise interventions of people with CHD. Two reviewers assessed the quality of SRs using the AMSTAR-2 tool and evaluated the strength of evidence quality with the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) system for relevant outcome measures. Mean difference (MD) and 95% confidence intervals (CIs) were calculated. RESULTS: Thirty-one SRs (with 125 RCTs) met the study criteria, including 33,608 patients. Compared with usual care, continuous aerobic exercise produced an improvement in peak oxygen consumption, MD of 3.8 mL kg-1 min-1 (95% CI: 3.204.4, I2 = 67%); high-intensity interval training, MD 6.1 mL kg-1 min-1 (95% CI: 0.4-11.8, I2 = 97%); resistance training, MD of 2.1 mL kg-1 min-1 (95% CI: 0.98-3.2, I2 = 60%); combined aerobic and resistance training, MD of 3.0 mL kg-1 min-1 (95% CI: 2.5-3.4, I2 = 0%); and water-based exercise, MD of 4.4 mL kg-1 min-1 (95% CI, 2.1-6.7; I2 = 2%). CONCLUSION: Exercise interventions improve peak oxygen consumption in people with CHD. However, there was moderate to very-low certainty for the evidence found.

Exercises for the prevention of non-specific low back pain.

OBJECTIVES: This is a protocol for a Cochrane Review (intervention). The objectives are as follows: To evaluate the effects of exercise alone or exercise plus education compared with inactive control or education alone to prevent non-specific LBP.

Pediatric dentistry systematic reviews using the GRADE approach: methodological study.

BACKGROUND: To assess the reporting of the certainty of the evidence using the GRADE approach in systematic reviews of interventions in pediatric dentistry. METHODS: The inclusion criteria were systematic reviews of randomized clinical trials (RCTs) and non-randomized studies of interventions (NRSIs) in pediatric dentistry that reported the certainty of the evidence through the GRADE approach. Paired independent reviewers screened the studies, extracted data, and appraised the methodological quality using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR 2) tool. The certainty of the evidence was extracted for each outcome. A descriptive analysis was conducted. RESULTS: Around 28% of pediatric dentistry reviews of interventions used the GRADE approach (n = 24). Twenty reviews reported 112 evidence outcomes from RCTs and 13 from NRSIs using GRADE evidence profile tables. The methodological quality was high (16.7%), moderate (12.5%), low (37.5%), and critically low (33.3%), fulfilling the majority of the AMSTAR 2 criteria. The certainty of the evidence for outcomes generated from RCTs and NRSIs was very low (40.2% and 84.6%), low (33.1% and 7.7%), moderate (17.8% and 7.7%), and high (9.8% and 0.0%). The main reasons to downgrade the certainty were due to (for RCTs and NRSIs, respectively): risk of bias (68.8% and 84.6%), imprecision (67.8% and 100.0%), inconsistency (18.8% and 23.1%), indirectness (17.8% and 0.0%), and publication bias (7.1% and 0.0%). CONCLUSION: The proportion of systematic reviews assessing the certainty of the evidence using the GRADE approach was considered small, considering the total initial number of published pediatric dentistry reviews of intervention. The certainty of the evidence was mainly very low and low, and the main problems for downgrading the certainty of evidence were due to risk of bias and imprecision. REGISTRATION: PROSPERO database #CRD42022365443.

Methodological quality of research on perioperative immunomodulatory supplementation in oncological gastrointestinal tract surgery: a meta-research protocol.

INTRODUCTION: One of the topics that show differences of opinion in the scientific field of nutrition is the recommendation by clinical practice guidelines (CPGs) of an immunomodulatory diet with arginine, nucleotides and omega-3 for individuals diagnosed with cancer undergoing major surgery. The quality of the recommendations is directly related to credibility, transparency and rigour in their development, but also to the quality of the studies published and available for inclusion in the recommendation, such as systematic reviews (SRs) and randomised clinical trials. The aim of this study is to evaluate the methodological quality of the recommendation of perioperative immunomodulatory supplementation for individuals with gastrointestinal and head and neck cancer, the CPGs, and the studies that support the recommendations. METHODS AND ANALYSIS: We will conduct a systematic search for CPGs. Recommendations for nutritional supplementation with immunomodulatory substrates for individuals undergoing major oncological surgery will be analysed using the Appraisal of Guidelines Research and Evaluation-Recommendations Excellence tool. CPGs will be analysed using the Appraisal of Guidelines Research and Evaluation II tool. The SRs cited in the recommendations will be analysed using the A Measurement Tool to Assess Systematic Reviews II tool and additional questions regarding heterogeneity in reviews. The clinical trials cited in the SRs and in the guideline recommendations (when applicable) will be analysed according to questions regarding heterogeneity in trials. The results will be presented in tables or charts using descriptive analyses. ETHICS AND DISSEMINATION: The results of this study will be disseminated through relevant conferences and peer-reviewed journals. PROTOCOL REGISTRATION NUMBER: 10.17605/OSF.IO/X2GYT.

Obesity-related cancer and bariatric surgery: A comprehensive systematic review and meta-analysis protocol.

INTRODUCTION: Obesity is a silent pandemic affecting all ages and is a component of metabolic syndrome. Its treatment is conducted by lifestyle and behavioral changes, pharmacological therapy, and when correctly indicated, bariatric surgery. In recent years, the procedures for weight loss have been investigated due to their relationship with the development of many types of cancer. Although many studies have shown that bariatric surgery decreases cancer risk, other researchers observed an increase in this association. Carcinogenesis is affected by many factors, such as age, sex, type of cancer, and the bariatric surgery performed on each patient. This systematic review and meta-analysis protocol aims to clarify the association between the different modalities of bariatric surgery and the risk of cancer development in adult patients with metabolic syndrome. METHOD AND ANALYSIS: The proposed systematic review and meta-analysis will be reported conforming to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA-P) guidelines. This research will include observational studies (case-control and cohort studies) about patients who undergo bariatric surgery due to metabolic syndrome. Will be accepted in any language and any year. Publications without peer review will be excluded from this review. Data will be entered into the Review Manager software (RevMan5.2.3). We extracted or calculated the OR and 95% CI for dichotomous outcomes for each study. In case of heterogeneity (I2>50%), the random-effects model will combine the studies to calculate the OR and 95% CI. ETHICS AND DISSEMINATION: This study will review the published data; Thus, obtaining ethical approval is unnecessary. The findings of this systematic review will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42023432079.

Physical therapy for muscle strengthening in individuals with amyotrophic lateral sclerosis: A protocol for a systematic review and meta-analysis.

INTRODUCTION: People with Amyotrophic Lateral Sclerosis (ALS) can present initially muscle weakness, which is a debilitating symptom that may be improved by engaging in muscle strengthening activities. Currently, the effects of motor interventions for muscle strengthening in people with ALS are unclear. This review intends to analyze the effects of motor interventions for muscle strengthening in individuals with ALS. METHODS AND ANALYSIS: Randomized, non-randomized, and quasi-experimental clinical trials assessing individuals with ALS of both sexes, aged 18 years or older, who have received motor interventions for muscle strengthening considering all practices that can lead to increased strength, endurance, power and muscular hypertrophy will be included. No restriction on language, location, or publication date will be applied. MEDLINE, EMBASE, Cochrane Library (CENTRAL), SPORTDiscus, and Physiotherapy Evidence Database (PEDro) databases will be searched. The US National Institutes of Health Ongoing, ClinicalTrials.gov, and the reference lists of included studies will also be searched. Two reviewers will independently screen titles and abstracts and extract data from included studies. The methodological quality of the included studies will be assessed by the PEDro scale and the certainty of the evidence by the GRADE approach. Disagreements will be resolved by a third researcher. Findings will be presented in text and table formats. A meta-analysis will compare the effects of motor interventions for muscle strengthening versus placebo or other interventions.

False claims of equivalence in the neurosurgical trauma literature: prevalence and associated factors-a systematic review protocol.

INTRODUCTION: Research quality within the neurosurgical field remains suboptimal. Therefore, many studies published in the neurosurgical literature lack enough statistical power to establish the presence or absence of clinically important differences between treatment arms. The field of neurotrauma deals with additional challenges, with fewer financial incentives and restricted resources in low-income and middle-income countries with the highest burden of neurotrauma diseases. In this systematic review, we aim to estimate the prevalence of false claims of equivalence in the neurosurgical trauma literature and identify its predictive factors. METHODS AND ANALYSIS: The Preferred Reporting Items for Systematic Review and Meta-Analyses recommendations were followed. Randomised clinical trials that enrolled only traumatic brain injury patients and investigated any type of intervention (surgical or non-surgical) will be eligible for inclusion. The MEDLINE/PubMed database will be searched for articles in English published from January 1960 to July 2020 in 15 top-ranked journals. A false claim of equivalence will be identified by insufficient power to detect a clinically meaningful effect: for categorical outcomes, a difference of at least 25% and 50%, and for continuous outcomes, a Cohen's d of at least 0.5 and 0.8. Using the number of patients in each treatment arm and the minimum effect sizes to be detected, the power of each study will be calculated with the assumption of a two-tailed alpha that equals 0.05. Standardised differences between the groups with and without a false claim of equivalence will be calculated, and the variables with a standardised difference equal or above 0.2 and 0.5 will be considered weakly and strongly associated with false claims of equivalence, respectively. The data analysis will be blinded to the authors and institutions of the studies. ETHICS AND DISSEMINATION: This study will not involve primary data collection. Therefore, formal ethical approval will not be required. The final systematic review will be published in a peer-reviewed journal and presented at appropriate conferences.

A critical analysis of the effect of OM-85 for the prevention of recurrent respiratory tract infections or wheezing/asthma from systematic reviews with meta-analysis.

Acute respiratory tract infections (RTIs) are one of the most common causes of pediatric consultations/hospitalizations and a major trigger for asthma exacerbations. Some consensus statements have recommended the use of immunostimulants to boost natural defenses against severe or repeated infections. One of the most common immunostimulants is OM-85; while several randomized clinical trials (RCTs) have evaluated its efficacy in preventing acute RTIs and wheezing/asthma exacerbations, results have been conflicting. Similarly, various systematic reviews with meta-analyses (SRMs) on OM-85 have used different strategies, populations, and outcomes; moreover, SRM conclusions are limited when the original studies are highly heterogeneous or have a low quality, hindering the generalizability of the findings. Here we summarize the evidence on the effect of OM-85 to prevent acute RTIs, wheezing/asthma episodes, or loss of asthma control in children, by including and critically evaluating all SRMs published to date. We searched for SRMs on OM-85 in three publication databases and found nine SRMs (seven for RTI, and two for wheezing/asthma). Among those, one had a high confidence evaluation of quality (AMSTAR-2 tool) and found a reduction in the total number of acute RTIs among the OM-85 group. Overall, no strong recommendations can be derived from the existing literature, mainly due to the high heterogeneity among included RCTs and SRMs. Further, large, high-quality RCTs are needed to confirm the true efficacy of OM-85 for the prevention of acute RTIs, asthma development, and asthma exacerbations.