Systematic Reviews最新文献

Background: Breast cancer is the fourth leading cause of cancer mortality worldwide. New drugs, such as cyclin-dependent kinase 4/6 inhibitors (CDKIs), increase the life expectancy of receptor-positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer patients. This class acts to limit the G1/S transition in tumor cells, inducing tumor cell death. Owing to the basic nature of CDKIs, their solubilities are pH dependent and could be influenced by the concurrent use of acid-reducing agents such as proton pump inhibitors (PPIs). This meta-analysis aims to assess the impact of co-administering PPIs on the pharmacokinetics and clinical efficacy of CDKIs in breast cancer patients.

Methods: Four databases with English-language restriction were searched for concomitant CDKIs and PPIs keywords from their inception date to 2024 March 7th. Prospective, retrospective, randomized or nonrandomized clinical studies and observational longitudinal studies with at least one outcome of interest were included. The outcomes included pharmacokinetic variables, progression-free survival (PFS), and overall survival (OS).

Results: We included three pharmacokinetic studies conducted in patients enrolled in clinical trials and seven clinical studies evaluating survival outcomes. When coadministered with palbociclib, PPIs significantly reduced the serum maximum concentration (Cmax) (MD -35.37 ng/mL; 95%CI from -67.59 to -3.16) and increased the clearance (CL/F) (MD 61.24 L/h; 95%CI from 14.66 to 107.82). Ribociclib Cmax and AUC did not significantly differ among the PPIs users. However, the overall PFS favored PPIs non-users (HR 1.74; 95%CI from 1.28 to 2.37). Consistently, coadministration of PPIs with CDKIs significantly increased the likelihood of reduced OS (HR 1.99; 95%CI from 1.18 to 3.33). The effect was confirmed only for the palbociclib subgroup (HR 2.11; 95%CI from 1.17 to 3.81). No data were available for OS evaluation with ribociclib. A single study on abemaciclib revealed nonsignificant differences (HR 1.30; 95%CI from 0.53 to 3.19), with similar results for OS.

Conclusions: PPI use in HR + /HER2- breast cancer patients treated with palociclib should be avoided. When strictly necessary, ribociclib may be preferred to palbociclib, even though closer monitoring is strongly advised.

Systematic review registration: PROSPERO identifier number CRD42024506456.

Introduction: The prevalence and mortality rates of type 2 diabetes mellitus (T2DM) are increasing, making it a significant public health concern. Effective self-management of T2DM requires external factors, such as medical interventions and social support, and internal factors, including self-efficacy. However, during humanitarian emergencies, such as the COVID-19 pandemic, healthcare system disruptions limit external factors, making internal factors even more critical. Nonetheless, existing reviews have primarily focused on external factors and clinical outcomes during the pandemic, with no comprehensive review examining internal factors. Therefore, this review aims to systematically synthesize evidence on the internal factors supporting T2DM self-management during the COVID-19 pandemic and identify research gaps.

Methods: This scoping review follows the Joanna Briggs Institute guidelines and is conducted according to the PRISMA-P framework. A comprehensive search strategy will be employed to systematically explore multiple databases, including PubMed (MEDLINE), CINAHL, Web of Science, Scopus, ERIC, PsycINFO, and the Cochrane Library, as well as gray literature platforms, such as Google, Google Scholar, and Semantic Scholar. The search will include both published and gray literature without language restrictions. Studies that utilize quantitative and qualitative methodologies will also be included. Two independent reviewers will screen titles, abstracts, and full texts for eligibility, and discrepancies will be resolved through discussion or consultation with a third reviewer. The outcomes related to the internal factors contributing to the improvement of self-management among T2DM patients will be extracted and summarized. The findings will be presented descriptively and in tabular form, emphasizing key insights and identifying research gaps in the literature.

Discussion: The findings will be actively disseminated through academic conferences and peer-reviewed journals to provide valuable insights into the internal factors that contribute to the improvement of self-management in T2DM patients. These results are expected to contribute to the development of innovative strategies for sustaining and improving self-management in T2DM patients during future humanitarian emergencies and major public health challenges.

Background: Phosphodiesterase type-5 inhibitors (PDE5is) are used for the treatment of erectile dysfunction (ED) and have potential cardioprotective effects. The impacts of PDE5is on cardiovascular parameters, which may be associated with the occurrence and progression of subclinical cardiovascular diseases, remain uncertain. In this study, we evaluated the effects of PDE5is on vascular parameters.

Methods: Randomized controlled trials (RCTs) that compared the effects of PDE5is and placebo on vascular parameters and were published from 1998 to 2022 were identified from PubMed, Scopus and Web of Science. Mean differences (MDs) with 95% confidence intervals (CIs) were pooled. A sensitivity analysis was conducted to confirm the robustness of the pooled results. The keywords that were searched in the databases are as follows: ((systolic blood pressure) OR (SBP) OR (diastolic blood pressure) OR (DBP) OR (mean arterial pressure) OR (MAP) OR (Pulse Wave Velocity) OR (PWV) OR (intima-media thickness) OR (cIMT) OR (augmentation Index) OR (AI) OR (FMD) OR (flow-mediated dilation) OR (reactive hyperemia index) OR (RHI) OR (Endothelial microparticles) OR (EMP) OR (EPCs) OR (Endothelial Progenitor Cells) OR (PSV) OR (peak systolic velocity)) AND ((PDE5 Inhibitors) OR (PDE5i) OR (Sildenafil) OR (Vardenafil) OR (Tadalafil) OR (Lodenafil) OR (Udenafil) OR (Avanafil)).

Results: Sixty-three studies involving 3242 subjects were included. Overall, PDE5is decreased systolic blood pressure (MD: -2.80 mmHg, 95% CI: -4.24, -1.37, P < 0.001), diastolic blood pressure (MD: -1.80 mmHg, 95% CI: -2.37, -1.22, P < 0.001), carotid intima‒media thickness (MD: -0.01 mm, 95% CI: -0.02, -0.01, P < 0.001), and pulse wave velocity (MD: -0.75 cm/s, 95% CI: -1.01, -0.49, P < 0.001). In addition, PDE5is increased the peak systolic velocity (MD: 3.70 cm/s, 95% CI: 3.52, 3.88, P < 0.001), flow-mediated dilation (MD: 2.47%, 95% CI: 1.24, 3.71, P < 0.001), concentration of endothelial progenitor cells (MD: 475.29 cells/mL, 95% CI: 51.38, 899.20, P = 0.03), and concentration of endothelial microparticles (MD: 4.86%, 95% CI: 0.65, 9.07, P = 0.02). However, the effects of PDE5is on the augmentation index, brachial artery diameter and reactive hyperemia index were not statistically significant.

Conclusion: Compared with the placebo, PDE5is improved vascular parameters, indicating the potential of PDE5is for treating subclinical cardiovascular diseases. Further research is needed to confirm the role of the improvement on vascular parameters by PDE5isin preventing and treating cardiovascular diseases.

Systematic review registration: The present study protocol was reviewed and approved by PROSPERO. The title is "Associations between PDE5is and vascular parameters: A systematic review and meta-analysis" ( https://www.crd.york.ac.uk/PROSPERO/ ) (Reg. No. CRD42023387924).

Introduction: Food insecurity is the violation of this right to regular and permanent access to quality food in sufficient quantity without compromising other essential needs and is associated with an increase in non-communicable chronic diseases (NCDs). Recyclable waste collectors' vulnerable social groups face a high risk of food insecurity due to low income, precarious working conditions, and a lack of public policies targeting them.

Objective: This systematic review aimed to investigate the prevalence of food insecurity as well as changes in nutritional status among recyclable waste collectors.

Methods: The review followed the Cochrane guidelines and was registered in PROSPERO. Five databases were searched and observational studies (cross-sectional, case--control, and cohort) were included. The primary outcome was the prevalence of food insecurity and secondary outcomes were nutritional status such as underweight, overweight, and obese. Meta-analysis was performed using the pooled crude proportions (PRAW) method and random effects in software R version 4.1.1.

Results: The search identified 10 studies involving 788 waste collectors. The prevalence of food insecurity was high, reaching 71% with Brazil showing the highest prevalence (77%). Overweight affected 47% of participants, with higher rates in Brazil (52%) compared to South Africa (25%). Additionally, 29% of the collectors were obese.

Conclusion: The high prevalence of food insecurity and overweight among recyclable waste collectors highlights the urgent need for specific public policies for this group.

Systematic review registration: PROSPERO CRD42025645499.

Background: This scoping review protocol aims to examine the current evidence base on the experiences, barriers, and facilitators of infant and young child feeding (IYCF) among adolescent mothers in sub-Saharan Africa (SSA). The review will help to identify the nature and extent of available research in this area and highlight evidence and knowledge gaps for future research. The work is significant because of the urgent need to understand the unique challenges faced by adolescent mothers in SSA and inform the development of evidence-based interventions to improve IYCF practices.

Methods: The review will be guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A comprehensive search strategy will be employed to identify relevant studies from electronic databases, grey literature, and additional sources. Four independent reviewers will conduct study selection, data extraction, and quality appraisal. Bronfenbrenner's bioecological model system levels will be used as a guiding framework to code, interpret and frame the results by identifying experiences, barriers, and enablers influencing IYCF practices at microsystem, mesosystem, exosystem, and macrosystem levels. Furthermore, the review will highlight gaps in existing literature, providing valuable insights for future research and evidence-based interventions.

Discussion: The study is aligned with global efforts to address child malnutrition and emphasizes the importance of evidence-based interventions in SSA and findings will be disseminated through publication in a peer-reviewed journal and presentation at national and international conferences. The protocol has been registered prospectively on the Open Science Framework ( https://osf.io/h7kzw ).

Background: The global shortage of organs and tissues highlights the need to strengthen and monitor the quality of deceased donor programs. Evaluating each stage of this process using quality-sensitive indicators is essential to ensure transparency, efficiency, safety, and effectiveness. However, there is still no consensus on which indicators best reflect the quality of organ and tissue donation processes, highlighting the need to map and analyze existing evidence. The aim of this study was to map and analyze international literature on indicators for monitoring the quality of the process of deceased organ and tissue donation for transplantation.

Methods: This review will be conducted following the methodology proposed by the JBI and guidelines for scope reviews. The databases, portals, and directories to be searched included MEDLINE (via PubMed), CINAHL (EBSCO), Embase (Elsevier), Scopus (Elsevier), Web of Science (Clarivate Analytics), Business Source Complete (EBSCO), VHL Virtual Health Library; gray literature will be sought on Google Scholar, OpenGrey (GreyNet), CAPES Theses and Dissertations, Global ETD Search (formerly the Union Catalog), Open Access Theses and Dissertations, and websites of organ and tissue donation and transplant organizations. Studies in any language and published after 1980 will be considered for inclusion. A wide range of study designs will be included, encompassing quantitative, qualitative, and mixed-methods research, as well as relevant gray literature on organ and tissue donation and transplantation. Two reviewers will screen the studies, paying attention to the eligibility criteria. The data will be extracted by means of specific variables and presented in categories according to the evaluative triad structure, process, and result, and by the pillars of quality proposed by Avedis Donabedian in the form of diagrams, tables, charts, and narrative synthesis.

Discussion: The evidence on quality indicators for organ and tissue donation processes is conceptually diverse. This scoping review will provide an overview of existing studies, identify gaps in current knowledge, and guide future research on the development and validation of quality indicators.

Systematic review registration: Open Science Framework osf.io/ymuvj/.

Objective: The study aimed to systematically review the evidence on the association between smoking and the risk of diabetic neuropathy, with a particular emphasis on the risk of peripheral neuropathy among individuals with diabetes mellitus.

Design and methods: MEDLINE, EMBASE, SCOPUS, and CENTRAL databases were searched for studies published before August 2024. Cross-sectional, case-control, and cohort studies that assessed the association between smoking and diabetic neuropathy in individuals diagnosed with diabetes mellitus (type 1 or type 2), reported smoking as an exposure, and any type of diabetic neuropathy as an outcome were included in the study. The risk of bias of the included studies was evaluated using the modified risk of bias in non-randomized studies-of exposures (ROBINS-E).

Results: Seventy-five articles, including 228,699 individuals with diabetes met the inclusion criteria. Fifty-four cross-sectional, 8 case-control, and 13 cohort studies provided data for the meta-analyses. Cohort studies demonstrated a significantly increased risk of diabetic peripheral neuropathy (RR 1.28; 95% CI 1.05, 1.51), the most prevalent subtype of diabetic neuropathy. Meta-analyses of cross-sectional and case-control revealed an increased risk of diabetic neuropathy (all types combined) among smokers with diabetes ([OR 1.29; 95% CI 1.17, 1.41], [OR 1.48; 95% CI 1.23, 1.72]). Meta-regression showed no statistically significant impact of total sample size and type of effect estimates on pooled effect estimates for cross-sectional, case-control, and cohort studies.

Conclusion: Smoking is associated with an increased risk of diabetic neuropathy, peripheral neuropathy in particular. Future research should evaluate the precise dynamics of neuropathy pathogenesis among individuals with diabetes to prevent such complications.

Systematic review registration: PROSPERO CRD42022363380.

Background: Sickle cell disease (SCD) is one of the most common genetic disorders in the world, with Nigeria believed to have the highest burden. Despite the high burden in the country, the true prevalence of SCD and its main driver-the sickle cell trait (SCT)-is unknown, which is important for planning and resource allocation. Hence, we conducted a systematic review and meta-analysis of the prevalence of SCD, SCT, and associated factors in Nigerian children and adolescents.

Methods: Using the PRISMA guidelines [ID: CRD42024556354], we systematically search the following major databases: AJOL, Google Scholar, PubMed, EMBASE, Cochrane Library, Scopus, and Web of Science collections from January 1950 to October 2024 on Nigerian children and adolescents with SCD and/or SCT. The quality of the studies was assessed using the Newcastle-Ottawa Scale adapted for cross-sectional studies. We performed a cumulative meta-analysis to estimate the pooled prevalence and associated factors for SCD and SCT.

Results: Thirty studies, comprising 211,938 participants, were included in the final analysis after stepwise screening. The pooled prevalences of SCD and SCT were 4.0% (95% CI 3.0 to 6.0, I² = 99.6%) and 21.0% (95% CI 20.0 to 23.0, I² = 90.5%), respectively. The northwestern geopolitical zone had the highest pooled prevalence of SCD (7.0%; 95% CI 3.0 to 11.0; I² = 98.9%) and SCT (23.0%; 95% CI 19.0 to 28.0%, I² = 54.2%). The southeastern region had the lowest pooled prevalence of SCD (2.0%, 95% CI 0.3 to 3.0%, I² = 96.5), whereas the southwestern region had the lowest pooled prevalence of SCT (19.0%, 95% CI 14.0 to 25.0%, I² = 92.2). There was no relationship between sex, socioeconomic status, and SCD.

Conclusion: The pooled prevalence of SCD and SCT among children and adolescents was high, with the highest burden occurring in the northwestern geopolitical zone in Nigeria. In addition, there was no relationship between sex, socioeconomic class, and prevalence of SCD.

Systematic review registration: PROSPERO ID: CRD42024556354.

Background: Feeding and eating disorders lead to serious health impairments. Boys and men are increasingly affected and may account for a fourth of clinical cases. Current evidence suggests that symptoms and health care needs differ between men and women (e.g., related to muscularity concerns), and that men delay seeking treatment due to the traditional understanding of eating disorders as "women's disease". Treatment guidelines recommend psychotherapy as first-line intervention, but potential gender differences in treatment responses have not been considered. This is due to the lack of systematic evaluations of gender differences related to treatment outcomes for feeding and eating disorders.

Methods: This systematic review with Individual Patient Data Meta-Analysis (IPDMA) will compare the effects of psychotherapeutic interventions for feeding and eating disorders between gender groups. The focus of the analysis is on eating disorders-related psychopathology. For this purpose, randomized-controlled clinical studies will be identified in scientific databases and examined for their methodological quality. Primary investigators will be contacted to deliver anonymized data of their studies. Study results will then be summarized and compared in a two-staged IPDMA. Gender groups will be compared regarding different types of interventions and further relevant intervention characteristics, as identified by men with lived experience.

Discussion: The results will help to formulate treatment recommendations and identify the treatment contexts that are associated with unfavorable outcomes related to patient gender. This may fuel efforts of adapting established interventions to best meet the health care needs of men and women in the context of eating disorders.

Systematic review registration: PROSPERO CRD42022372712.

Background: With the development of remote technology, decentralized clinical trials have rapidly increased in recent years. Despite the comprehensive reporting guidance provided by the CONSORT 2025 guideline, decentralized randomized controlled trials still face specific reporting challenges. Therefore, we aim to evaluate the reporting characteristics and completeness of decentralized randomized controlled trials, using a specially designed checklist that has been extended according to the CONSORT 2025 original items.

Methods: We will search six databases (Embase, Ovid MEDLINE®, PubMed, CNKI, VIP, Wanfang) for decentralized randomized controlled trials published in Chinese or English during 2023. A pre-designed form will be used to extract general characteristics. Reporting completeness will be assessed using a custom 26-item "CONSORT-DRCT" checklist. This checklist includes 17 items focused on design, implementation, quality control, and key technologies related to decentralized elements, while 9 items pertain specifically to intervention details (5 for pharmacological interventions and 4 for non-pharmacological interventions). To ensure consistency, a standard operating procedure for scoring reporting completeness will be developed. Each item will be evaluated independently by two reviewers, and inter-rater agreement will be calculated to assess consistency between reviewers. Data will undergo descriptive analysis, with subgroup analyses performed where applicable to explore factors influencing reporting completeness.

Discussion: This protocol outlines a methodological framework for conducting the review, which aims to identify the current reporting characteristics and completeness of decentralized randomized controlled trials. The results may offer valuable insights into the development of a CONSORT extension guideline for decentralized randomized controlled trials.

Systematic review registration: This study has been registered with the Open Science Framework ( https://osf.io/c9pdx/ ).