Pub Date : 2024-11-20DOI: 10.1186/s13643-024-02698-8
Veronika Bencheva, Nina-Kristin Mann, Tanja Rombey, Dawid Pieper, Sven Schmiedl
Background: Recruiting a sufficient number of patients is often a challenge for conducting clinical trials. Published data reveal that only 10% of eligible patients according to inclusion and exclusion criteria are enrolled in clinical trials. Consequentially, identifying barriers and facilitators may improve enrollment. These factors may differ in the pediatric population, for example, due to the involvement of parents in the decision-making process. We aimed to conduct an overview of systematic reviews to summarize the barriers and facilitators influencing the enrollment of pediatric participants in clinical trials.
Methods: A systematic literature search in PubMed and Epistemonikos of published systematic reviews focusing on barriers and facilitators influencing the enrollment of pediatric patients in clinical trials was conducted. Study selection, data extraction, and quality assessment were performed by two authors independently. The methodological quality was judged using a critical appraisal tool. Finally, data were narratively synthesized.
Results: Of 283 identified systematic reviews, four met the inclusion criteria and were included in the overview. Parents belonging to an ethnic minority or having low socioeconomic status were identified as barriers to enrollment whereas higher parental education and higher age served as facilitators. Additionally, existing expectations, previous treatment experiences and preferences, study duration, type of control group, and the child's attitude toward study participation could favor or hinder participation. Furthermore, physicians' opinions of study-related treatments may also influence the enrollment process.
Conclusion: This overview provides a summary of barriers and facilitators to the enrollment of pediatric patients in clinical trials. Taking into account this information may enhance the enrollment of this hard-to-reach population.
{"title":"Barriers and facilitators to enrollment in pediatric clinical trials: an overview of systematic reviews.","authors":"Veronika Bencheva, Nina-Kristin Mann, Tanja Rombey, Dawid Pieper, Sven Schmiedl","doi":"10.1186/s13643-024-02698-8","DOIUrl":"10.1186/s13643-024-02698-8","url":null,"abstract":"<p><strong>Background: </strong>Recruiting a sufficient number of patients is often a challenge for conducting clinical trials. Published data reveal that only 10% of eligible patients according to inclusion and exclusion criteria are enrolled in clinical trials. Consequentially, identifying barriers and facilitators may improve enrollment. These factors may differ in the pediatric population, for example, due to the involvement of parents in the decision-making process. We aimed to conduct an overview of systematic reviews to summarize the barriers and facilitators influencing the enrollment of pediatric participants in clinical trials.</p><p><strong>Methods: </strong>A systematic literature search in PubMed and Epistemonikos of published systematic reviews focusing on barriers and facilitators influencing the enrollment of pediatric patients in clinical trials was conducted. Study selection, data extraction, and quality assessment were performed by two authors independently. The methodological quality was judged using a critical appraisal tool. Finally, data were narratively synthesized.</p><p><strong>Results: </strong>Of 283 identified systematic reviews, four met the inclusion criteria and were included in the overview. Parents belonging to an ethnic minority or having low socioeconomic status were identified as barriers to enrollment whereas higher parental education and higher age served as facilitators. Additionally, existing expectations, previous treatment experiences and preferences, study duration, type of control group, and the child's attitude toward study participation could favor or hinder participation. Furthermore, physicians' opinions of study-related treatments may also influence the enrollment process.</p><p><strong>Conclusion: </strong>This overview provides a summary of barriers and facilitators to the enrollment of pediatric patients in clinical trials. Taking into account this information may enhance the enrollment of this hard-to-reach population.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"283"},"PeriodicalIF":6.3,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11577732/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142682829","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-20DOI: 10.1186/s13643-024-02473-9
Lu Zhou, LiXiong Bi, YuMing Wu, Lei Wang, Gao Liu, EnLi Cai
<p><strong>Background: </strong>Recognizing and appropriately responding to ethical considerations is a crucial element of ethical nursing practice. To mitigate instances of ethical incongruity in healthcare and to promote nurses' comprehension of their professional ethical responsibilities, it is imperative for researchers to accurately evaluate ethical sensitivity. Conducting a systematic review of the available instruments would enable practitioners to determine the most suitable instrument for implementation in the field of nursing.</p><p><strong>Aim: </strong>This review aims to systematically assess the measurement properties of instruments used to measure ethical sensitivity in nursing.</p><p><strong>Methods: </strong>A systematic literature search was conducted in July 2022 in the following electronic databases: Scopus, CINAHL, APAPsycINFO, Embase, Web of Science, and PubMed. Two reviewers independently screened and assessed the studies in accordance with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. The updated criteria for good measurement properties are used to rate the result of measurement properties, and the modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to grade the quality of the summarized evidence.</p><p><strong>Results: </strong>This review encompasses a total of 29 studies that describe 11 different instruments. Neither cross-cultural validity nor responsiveness was examined in any of the included studies. Whereas the majority of the instruments were conducted with at least some type of validity assessment, nearly all of the reliability results rated were indeterminate. Two instruments were recommended, the Ethical Sensitivity Questionnaire for Nursing Students (ESQ-NS) and the Ethical Awareness Scale for nurses in intensive care units. It is recommended that new self-administration instruments for special nursing settings be developed in accordance with the item response theory (IRT)/Rasch model.</p><p><strong>Conclusion: </strong>The selection of ethical sensitivity measurement instruments in nursing, and further research on the development, psychometric, and cross-cultural adaptation of these instruments, could be conducted in accordance with the findings and suggestions of this systematic review.</p><p><strong>Strengths and limitations: </strong>• This review was conducted to assess 11 instruments that were used to measure ethical sensitivity in nursing in 29 studies. • The Ethical Sensitivity Questionnaire for Nursing Students (ESQ-NS) and the Ethical Awareness Scale for nurses in intensive care units can be recommended, but further reliability and cross-cultural validity testing are needed. • The IRT/Rasch model is also recommended to measure ethical sensitivity in nursing. • The potential limitation of utilizing the COSMIN checklist for assessing methodological quality is worth considering. • Test-retest was con
{"title":"The psychometric properties of instruments measuring ethical sensitivity in nursing: a systematic review.","authors":"Lu Zhou, LiXiong Bi, YuMing Wu, Lei Wang, Gao Liu, EnLi Cai","doi":"10.1186/s13643-024-02473-9","DOIUrl":"10.1186/s13643-024-02473-9","url":null,"abstract":"<p><strong>Background: </strong>Recognizing and appropriately responding to ethical considerations is a crucial element of ethical nursing practice. To mitigate instances of ethical incongruity in healthcare and to promote nurses' comprehension of their professional ethical responsibilities, it is imperative for researchers to accurately evaluate ethical sensitivity. Conducting a systematic review of the available instruments would enable practitioners to determine the most suitable instrument for implementation in the field of nursing.</p><p><strong>Aim: </strong>This review aims to systematically assess the measurement properties of instruments used to measure ethical sensitivity in nursing.</p><p><strong>Methods: </strong>A systematic literature search was conducted in July 2022 in the following electronic databases: Scopus, CINAHL, APAPsycINFO, Embase, Web of Science, and PubMed. Two reviewers independently screened and assessed the studies in accordance with the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. The updated criteria for good measurement properties are used to rate the result of measurement properties, and the modified Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach was used to grade the quality of the summarized evidence.</p><p><strong>Results: </strong>This review encompasses a total of 29 studies that describe 11 different instruments. Neither cross-cultural validity nor responsiveness was examined in any of the included studies. Whereas the majority of the instruments were conducted with at least some type of validity assessment, nearly all of the reliability results rated were indeterminate. Two instruments were recommended, the Ethical Sensitivity Questionnaire for Nursing Students (ESQ-NS) and the Ethical Awareness Scale for nurses in intensive care units. It is recommended that new self-administration instruments for special nursing settings be developed in accordance with the item response theory (IRT)/Rasch model.</p><p><strong>Conclusion: </strong>The selection of ethical sensitivity measurement instruments in nursing, and further research on the development, psychometric, and cross-cultural adaptation of these instruments, could be conducted in accordance with the findings and suggestions of this systematic review.</p><p><strong>Strengths and limitations: </strong>• This review was conducted to assess 11 instruments that were used to measure ethical sensitivity in nursing in 29 studies. • The Ethical Sensitivity Questionnaire for Nursing Students (ESQ-NS) and the Ethical Awareness Scale for nurses in intensive care units can be recommended, but further reliability and cross-cultural validity testing are needed. • The IRT/Rasch model is also recommended to measure ethical sensitivity in nursing. • The potential limitation of utilizing the COSMIN checklist for assessing methodological quality is worth considering. • Test-retest was con","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"87"},"PeriodicalIF":6.3,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11577582/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142676836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-16DOI: 10.1186/s13643-024-02704-z
Kehinde Charles Mofolorunsho, Vinogrin Dorsamy, Chauntelle Bagwandeen, Nathlee Samantha Abbai
Background: Men who have sex with men (MSM) are disproportionately affected by sexually transmitted infections (STI) including Neisseria gonorrhoeae (Ng) and Chlamydia trachomatis (Ct). The lack of robust data on STIs among African MSM has limited the development of evidence-based screening strategies. This study aimed at documenting the pooled prevalence of Ng/Ct among MSM in sub-Saharan Africa (SSA).
Methods: This systematic review was performed according to the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) 2020 guidelines. Relevant articles from the following databases were searched: PubMed, Scopus, ISI Web of Science, and the Directory of Open Access Journals (DOAJ). Eligible studies reported on the prevalence of Ng/Ct among the MSM population in SSA. Publication bias was assessed using the Hoy tool, Doi plot, and LFK ratio. Due to heterogeneity among studies, subgroup analyses were performed using the MetaXL add-on tool for Microsoft Excel.
Results: Of 525 articles screened, 20 were selected for inclusion. Six were cross-sectional, four had a prospective cohort study design, and one was an epidemiological study. The pooled prevalence of Ng/Ct in MSM was 27% (95% CI, 19-39%), with an I2 of 98% signifying heterogeneity among the studies. Subgroup analysis by country revealed South Africa had the highest prevalence (38%).
Discussion: Interpretation The high prevalence of Ng/Ct infection among MSM in SSA is of concern. Limitations Due to limited data available on Ng/Ct prevalence, the true prevalence of SSA and its associated risk factors is uncertain.
Conclusion: As the first study to systematically review the available literature on STI prevalence among the MSM population in SSA, it showed the burden of Ng/Ct is higher than in other regions, warranting the strengthening of health systems to improve education, testing, and treatment in MSM population.
背景:包括淋病奈瑟菌(Ng)和沙眼衣原体(Ct)在内的性传播感染(STI)对男男性行为者(MSM)的影响尤为严重。由于缺乏有关非洲男男性行为者性传播感染的可靠数据,以证据为基础的筛查策略的制定受到了限制。本研究旨在记录撒哈拉以南非洲(SSA)男男性行为者中Ng/Ct的总体流行率:本系统综述根据《系统综述与元分析首选报告项目》(PRISMA)2020 指南进行。检索了以下数据库中的相关文章:PubMed、Scopus、ISI Web of Science 和 Directory of Open Access Journals (DOAJ)。符合条件的研究报告了Ng/Ct在SSA地区MSM人群中的流行情况。采用 Hoy 工具、Doi 图和 LFK 比值对发表偏倚进行了评估。由于研究之间存在异质性,因此使用 Microsoft Excel 的 MetaXL 附加工具进行了亚组分析:在筛选出的 525 篇文章中,有 20 篇被选中纳入研究。其中 6 篇为横断面研究,4 篇为前瞻性队列研究,1 篇为流行病学研究。汇总的男男性行为者Ng/Ct患病率为27%(95% CI,19%-39%),I2为98%,表明研究之间存在异质性。按国家进行的分组分析显示,南非的患病率最高(38%):释义 在撒哈拉以南非洲地区的男男性行为者中,Ng/Ct 感染的高流行率令人担忧。局限性 由于有关Ng/Ct感染率的数据有限,SSA的真实感染率及其相关风险因素尚不确定:作为第一项系统回顾性传播疾病在 SSA MSM 人口中流行情况的现有文献的研究,该研究表明,Ng/Ct 的负担高于其他地区,因此有必要加强卫生系统,以改善 MSM 人口的教育、检测和治疗:系统综述注册:prospero crd42022327095。
{"title":"Prevalence of gonococcal and chlamydial infections among men who have sex with men in sub-Saharan Africa: a systematic review and meta-analysis.","authors":"Kehinde Charles Mofolorunsho, Vinogrin Dorsamy, Chauntelle Bagwandeen, Nathlee Samantha Abbai","doi":"10.1186/s13643-024-02704-z","DOIUrl":"10.1186/s13643-024-02704-z","url":null,"abstract":"<p><strong>Background: </strong>Men who have sex with men (MSM) are disproportionately affected by sexually transmitted infections (STI) including Neisseria gonorrhoeae (Ng) and Chlamydia trachomatis (Ct). The lack of robust data on STIs among African MSM has limited the development of evidence-based screening strategies. This study aimed at documenting the pooled prevalence of Ng/Ct among MSM in sub-Saharan Africa (SSA).</p><p><strong>Methods: </strong>This systematic review was performed according to the Preferred Reporting Items for Systematic Review and Meta-analyses (PRISMA) 2020 guidelines. Relevant articles from the following databases were searched: PubMed, Scopus, ISI Web of Science, and the Directory of Open Access Journals (DOAJ). Eligible studies reported on the prevalence of Ng/Ct among the MSM population in SSA. Publication bias was assessed using the Hoy tool, Doi plot, and LFK ratio. Due to heterogeneity among studies, subgroup analyses were performed using the MetaXL add-on tool for Microsoft Excel.</p><p><strong>Results: </strong>Of 525 articles screened, 20 were selected for inclusion. Six were cross-sectional, four had a prospective cohort study design, and one was an epidemiological study. The pooled prevalence of Ng/Ct in MSM was 27% (95% CI, 19-39%), with an I<sup>2</sup> of 98% signifying heterogeneity among the studies. Subgroup analysis by country revealed South Africa had the highest prevalence (38%).</p><p><strong>Discussion: </strong>Interpretation The high prevalence of Ng/Ct infection among MSM in SSA is of concern. Limitations Due to limited data available on Ng/Ct prevalence, the true prevalence of SSA and its associated risk factors is uncertain.</p><p><strong>Conclusion: </strong>As the first study to systematically review the available literature on STI prevalence among the MSM population in SSA, it showed the burden of Ng/Ct is higher than in other regions, warranting the strengthening of health systems to improve education, testing, and treatment in MSM population.</p><p><strong>Systematic review registration: </strong>PROSPERO CRD42022327095.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"282"},"PeriodicalIF":6.3,"publicationDate":"2024-11-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11568532/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142644732","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-14DOI: 10.1186/s13643-024-02672-4
Jule Pinter, David J Tunnicliffe, Pooshwikaa Karunikaikumar, Anastasios Anastasiadis, Robert K Hills
Background: Patients with kidney failure often lack robust evidence because they are excluded from randomized trials. Trial emulation provides an alternative approach to derive treatment effect estimates when randomized trials cannot be conducted. Critical questions about the comparative efficacy and safety of interventions in kidney failure are now being answered using this approach or parts of it. However, variations and inconsistencies in reporting cast doubt on the reliability and validity of effect estimates not derived from randomized trials. The aim of this methodological systematic review is to understand the extent to which the target study approach is used in kidney failure and the appropriateness of this approach. By identifying and evaluating studies that qualify as emulating a target trial, compared with studies that did not apply the principles. We aim to provide more specific methodological guidance to increase the clarity and reliability of reporting treatment effect estimates when running a trial in kidney failure is not feasible.
Methods: This protocol is developed in accordance with Preferred Reporting Items for Systematic reviews and Meta-Analyses Protocols (PRISMA-P) statement. MEDLINE, Embase, and reference lists (backwards citation chasing) will be searched up until 1st July 2023 and the search updated prior to publication to identify all studies evaluating patient outcomes in late-stage kidney disease and failure that use target trial emulation as the primary approach for analysis. Two authors (A. A., P. K.) will select articles based on title and abstract and then full text, with a third reviewer settling disagreements (J. P.). The prespecified variables will be extracted, and the risk of bias will be assessed by at least two authors (A. A., P. K., A. N.) using prespecified data forms. This will enable the determination of the robustness of the methodological quality of observational studies in using the whole or elements of the target trial approach. We will thereby assess their ability to reliably report treatment effect estimates.
Discussion: We will provide specific methodological recommendations on how to design target trials and model assumptions for emulation to get reliable treatment effect estimates for therapeutic interventions in kidney failure.
Methodological systematic review registration: Open Science Framework: Identifier https://doi.org/10.17605/OSF.IO/Z4Y29 .
背景:肾衰竭患者往往被排除在随机试验之外,因此缺乏有力的证据。在无法进行随机试验的情况下,试验仿真为得出治疗效果估计值提供了另一种方法。目前,有关肾衰竭干预措施的比较疗效和安全性的关键问题正在通过这种方法或部分方法得到解答。然而,报告中的差异和不一致性使人们对非随机试验得出的疗效估计值的可靠性和有效性产生了怀疑。本方法学系统综述旨在了解目标研究法在肾衰竭中的应用程度以及该方法的适宜性。通过识别和评估符合目标试验条件的研究,并与未采用目标试验原则的研究进行比较。我们旨在提供更具体的方法学指导,以提高在肾衰竭中进行试验不可行时报告治疗效果估计值的清晰度和可靠性:方法:本方案根据系统综述和荟萃分析首选报告项目(PRISMA-P)声明制定。我们将检索MEDLINE、Embase和参考文献列表(反向引用追溯),直至2023年7月1日,并在发表前更新检索结果,以确定所有评估晚期肾病和肾衰竭患者预后的研究,这些研究以目标试验模拟作为主要分析方法。两位作者(A. A. 和 P. K.)将根据标题和摘要选择文章,然后再选择全文,由第三位审稿人(J. P.)解决分歧。至少两名作者(A. A.、P. K.、A. N.)将使用预先指定的数据表格提取预先指定的变量并评估偏倚风险。这将有助于确定观察性研究在使用目标试验方法的全部或部分内容时方法质量的稳健性。因此,我们将评估这些研究可靠地报告治疗效果估计值的能力:我们将就如何设计目标试验和模型假设提供具体的方法学建议,以便为肾衰竭的治疗干预获得可靠的治疗效果估计值:开放科学框架:标识符 https://doi.org/10.17605/OSF.IO/Z4Y29 。
{"title":"Review of the target trial methodological approach on treatment effect estimates in kidney failure: protocol for a systematic assessment.","authors":"Jule Pinter, David J Tunnicliffe, Pooshwikaa Karunikaikumar, Anastasios Anastasiadis, Robert K Hills","doi":"10.1186/s13643-024-02672-4","DOIUrl":"10.1186/s13643-024-02672-4","url":null,"abstract":"<p><strong>Background: </strong>Patients with kidney failure often lack robust evidence because they are excluded from randomized trials. Trial emulation provides an alternative approach to derive treatment effect estimates when randomized trials cannot be conducted. Critical questions about the comparative efficacy and safety of interventions in kidney failure are now being answered using this approach or parts of it. However, variations and inconsistencies in reporting cast doubt on the reliability and validity of effect estimates not derived from randomized trials. The aim of this methodological systematic review is to understand the extent to which the target study approach is used in kidney failure and the appropriateness of this approach. By identifying and evaluating studies that qualify as emulating a target trial, compared with studies that did not apply the principles. We aim to provide more specific methodological guidance to increase the clarity and reliability of reporting treatment effect estimates when running a trial in kidney failure is not feasible.</p><p><strong>Methods: </strong>This protocol is developed in accordance with Preferred Reporting Items for Systematic reviews and Meta-Analyses Protocols (PRISMA-P) statement. MEDLINE, Embase, and reference lists (backwards citation chasing) will be searched up until 1st July 2023 and the search updated prior to publication to identify all studies evaluating patient outcomes in late-stage kidney disease and failure that use target trial emulation as the primary approach for analysis. Two authors (A. A., P. K.) will select articles based on title and abstract and then full text, with a third reviewer settling disagreements (J. P.). The prespecified variables will be extracted, and the risk of bias will be assessed by at least two authors (A. A., P. K., A. N.) using prespecified data forms. This will enable the determination of the robustness of the methodological quality of observational studies in using the whole or elements of the target trial approach. We will thereby assess their ability to reliably report treatment effect estimates.</p><p><strong>Discussion: </strong>We will provide specific methodological recommendations on how to design target trials and model assumptions for emulation to get reliable treatment effect estimates for therapeutic interventions in kidney failure.</p><p><strong>Methodological systematic review registration: </strong>Open Science Framework: Identifier https://doi.org/10.17605/OSF.IO/Z4Y29 .</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"280"},"PeriodicalIF":6.3,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566441/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628010","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Hypoxemia is a common complication of sedation. This meta-analysis aimed to evaluate the efficacy and safety of supraglottic jet oxygenation and ventilation (SJOV) in preventing hypoxemia during sedative procedures.
Methods: Randomized controlled trials (RCTs) that compared SJOV with conventional oxygen therapy in sedated patients were searched in five databases (MEDLINE, EMBASE, Cochrane Library, China National Knowledge Infrastructure [CNKI], and Google Scholar) from their inception to March 2024. The primary outcome was the proportion of patients who developed hypoxia (SpO2 < 90%). The secondary outcomes included subclinical respiratory depression (90% ≤ SpO2 < 95%), severe hypoxemia (SpO2 < 75%), airway interventions, adverse events, hemodynamics, propofol dosage, and procedure time. The certainty of evidence was determined using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
Results: Twelve trials (n = 3058) were included in the analysis. The evidence suggests that SJOV results in a large reduction in the risk of hypoxemia (risk ratio [RR], 0.26; 95% confidence interval, 0.19-0.36; low certainty) and subclinical respiratory depression (RR, 0.40; low certainty) compared with the control. SJOV likely resulted in a large reduction in the risk of severe hypoxemia (RR, 0.22; moderate certainty). In addition, it may result in a large reduction in the need for jaw lift (RR, 0.22; low certainty) and mask ventilation (RR, 0.13; low certainty). The risk of sore throat probably increases with SJOV (RR, 1.71; moderate certainty), whereas SJOV may result in little to no difference in nasal bleeding (RR, 1.75; low certainty). Evidence is very uncertain regarding the effect of SJOV on hemodynamics (very low certainty) and procedure time (very low certainty). SJOV probably resulted in little to no difference in sedative doses between the groups (moderate certainty).
Conclusion: According to the GRADE approach, SJOV likely results in a large reduction in the risk of severe hypoxemia but probably increases the risk of sore throat. Compared with the control, evidence suggests that SJOV results in a large reduction in the risk of hypoxemia, subclinical respiratory depression, and the need for airway manipulation, with little to no difference in nasal bleeding. The integration of SJOV into clinical practice may help minimize hypoxemic events in at-risk patients.
{"title":"Efficacy and safety of supraglottic jet oxygenation and ventilation to minimize sedation-related hypoxemia: a meta-analysis with GRADE approach.","authors":"I-Wen Chen, Wei-Ting Wang, Pei-Chun Lai, Chun-Ning Ho, Chien-Ming Lin, Yao-Tsung Lin, Yen-Ta Huang, Kuo-Chuan Hung","doi":"10.1186/s13643-024-02707-w","DOIUrl":"10.1186/s13643-024-02707-w","url":null,"abstract":"<p><strong>Introduction: </strong>Hypoxemia is a common complication of sedation. This meta-analysis aimed to evaluate the efficacy and safety of supraglottic jet oxygenation and ventilation (SJOV) in preventing hypoxemia during sedative procedures.</p><p><strong>Methods: </strong>Randomized controlled trials (RCTs) that compared SJOV with conventional oxygen therapy in sedated patients were searched in five databases (MEDLINE, EMBASE, Cochrane Library, China National Knowledge Infrastructure [CNKI], and Google Scholar) from their inception to March 2024. The primary outcome was the proportion of patients who developed hypoxia (SpO<sub>2</sub> < 90%). The secondary outcomes included subclinical respiratory depression (90% ≤ SpO<sub>2</sub> < 95%), severe hypoxemia (SpO<sub>2</sub> < 75%), airway interventions, adverse events, hemodynamics, propofol dosage, and procedure time. The certainty of evidence was determined using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.</p><p><strong>Results: </strong>Twelve trials (n = 3058) were included in the analysis. The evidence suggests that SJOV results in a large reduction in the risk of hypoxemia (risk ratio [RR], 0.26; 95% confidence interval, 0.19-0.36; low certainty) and subclinical respiratory depression (RR, 0.40; low certainty) compared with the control. SJOV likely resulted in a large reduction in the risk of severe hypoxemia (RR, 0.22; moderate certainty). In addition, it may result in a large reduction in the need for jaw lift (RR, 0.22; low certainty) and mask ventilation (RR, 0.13; low certainty). The risk of sore throat probably increases with SJOV (RR, 1.71; moderate certainty), whereas SJOV may result in little to no difference in nasal bleeding (RR, 1.75; low certainty). Evidence is very uncertain regarding the effect of SJOV on hemodynamics (very low certainty) and procedure time (very low certainty). SJOV probably resulted in little to no difference in sedative doses between the groups (moderate certainty).</p><p><strong>Conclusion: </strong>According to the GRADE approach, SJOV likely results in a large reduction in the risk of severe hypoxemia but probably increases the risk of sore throat. Compared with the control, evidence suggests that SJOV results in a large reduction in the risk of hypoxemia, subclinical respiratory depression, and the need for airway manipulation, with little to no difference in nasal bleeding. The integration of SJOV into clinical practice may help minimize hypoxemic events in at-risk patients.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"281"},"PeriodicalIF":6.3,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11566649/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142627881","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-13DOI: 10.1186/s13643-024-02703-0
Long Zhu, Lijia Ou, Binjie Liu, Yang Yang, Chang Su, Ousheng Liu, Hui Feng
Background: Fibrosis is the ultimate, common pathological ending of most chronic inflammatory diseases and increases the chances of developing life-threatening illnesses. Pyroptosis, a newfound form of lytic programmed cell death initiated by the inflammasome, has received more and more attention because of its association with fibrotic diseases. Therefore, this study visualizes the connection between pyroptosis and fibrosis research through bibliometric methods, aimed at providing global research hits and tendencies in the field.
Methods: We collected and analyzed the articles on pyroptosis and fibrosis from 2010 to 2024 via Web of Science. Visual data analysis was performed for countries, institutions, authors, references, and keywords in the field using VOSviewer, CiteSpace software, the "Bibliometrix" R package, the bibliometric website ( https://bibliometric.com/ ), and Excel software. We analyzed the data by utilizing the bibliometric review method.
Results: A total of 566 articles and reviews relating to pyroptosis and fibrosis were identified in the Web of Science. The number of publications in the domain has continued to grow since 2010. These scientific outputs were mainly from 129 countries/regions and 1919 institutions, particularly China (n = 423) and the USA (n = 83). More importantly, although China publishes a vast majority of articles, its centrality is lower than that of the USA (0.59 vs 0.61). Among the 3833 authors involved in this field, Feldstein, A. E. is the most prolific author. Shi, J. J. is the world's most-cited author among the 12,143 authors in these academic journals. Frontiers in Immunology was a prolific contributor, and Nature was the most frequently cited journal. After analysis, Cleavage of GSDMD by inflammatory caspases determines pyroptotic cell death were the top-cited articles. The analysis of keywords displayed that pyroptosis, fibrosis, and pathways were the main research hotspots and frontier directions in recent years.
Conclusion: We analyzed the characteristics of published articles and drew a fundamental knowledge structure on pyroptosis and fibrosis research via bibliometric analysis. The potential mechanism between fibrosis and pyroptosis is deeply tied to the current moment. Our findings can help researchers make clear the research status and value of fibrosis and pyroptosis and provide new directions for future research as soon as possible.
背景:纤维化是大多数慢性炎症性疾病的最终常见病理结局,会增加患上危及生命的疾病的几率。由炎性体引发的一种新发现的细胞溶解性程序性死亡形式--裂解酶,因其与纤维化疾病的关联而受到越来越多的关注。因此,本研究通过文献计量学方法直观地展示了热蛋白沉积症与纤维化研究之间的联系,旨在提供该领域的全球研究热点和趋势:我们通过 Web of Science 收集并分析了 2010 年至 2024 年有关热蛋白沉积症和纤维化的文章。我们使用 VOSviewer、CiteSpace 软件、"Bibliometrix "R 软件包、文献计量学网站 ( https://bibliometric.com/ ) 和 Excel 软件对该领域的国家、机构、作者、参考文献和关键词进行了可视化数据分析。我们利用文献计量学审查方法对数据进行了分析:结果:我们在 Web of Science 上共找到了 566 篇与热病和纤维化相关的文章和综述。自 2010 年以来,该领域的论文数量持续增长。这些科学成果主要来自 129 个国家/地区和 1919 个机构,尤其是中国(n = 423)和美国(n = 83)。更重要的是,尽管中国发表了绝大多数文章,但其中心度却低于美国(0.59 对 0.61)。在该领域的 3833 位作者中,Feldstein, A. E. 是最多产的作者。在这些学术期刊的 12,143 位作者中,Shi, J. J. 是世界上被引用次数最多的作者。免疫学前沿》是多产作者,《自然》是被引用次数最多的期刊。经过分析,GSDMD 被炎性 Caspases 分解决定了细胞的热解死亡是被引用最多的文章。关键词分析表明,热变态、纤维化和通路是近年来的主要研究热点和前沿方向:我们分析了已发表文章的特点,并通过文献计量学分析得出了热解和纤维化研究的基本知识结构。纤维化与热蛋白沉积之间的潜在机制与当下的研究息息相关。我们的研究结果可以帮助研究人员明确纤维化和热病的研究现状和价值,并尽快为未来的研究提供新的方向。
{"title":"The pyroptosis and fibrotic diseases: a bibliometric analysis from 2010 to 2024.","authors":"Long Zhu, Lijia Ou, Binjie Liu, Yang Yang, Chang Su, Ousheng Liu, Hui Feng","doi":"10.1186/s13643-024-02703-0","DOIUrl":"10.1186/s13643-024-02703-0","url":null,"abstract":"<p><strong>Background: </strong>Fibrosis is the ultimate, common pathological ending of most chronic inflammatory diseases and increases the chances of developing life-threatening illnesses. Pyroptosis, a newfound form of lytic programmed cell death initiated by the inflammasome, has received more and more attention because of its association with fibrotic diseases. Therefore, this study visualizes the connection between pyroptosis and fibrosis research through bibliometric methods, aimed at providing global research hits and tendencies in the field.</p><p><strong>Methods: </strong>We collected and analyzed the articles on pyroptosis and fibrosis from 2010 to 2024 via Web of Science. Visual data analysis was performed for countries, institutions, authors, references, and keywords in the field using VOSviewer, CiteSpace software, the \"Bibliometrix\" R package, the bibliometric website ( https://bibliometric.com/ ), and Excel software. We analyzed the data by utilizing the bibliometric review method.</p><p><strong>Results: </strong>A total of 566 articles and reviews relating to pyroptosis and fibrosis were identified in the Web of Science. The number of publications in the domain has continued to grow since 2010. These scientific outputs were mainly from 129 countries/regions and 1919 institutions, particularly China (n = 423) and the USA (n = 83). More importantly, although China publishes a vast majority of articles, its centrality is lower than that of the USA (0.59 vs 0.61). Among the 3833 authors involved in this field, Feldstein, A. E. is the most prolific author. Shi, J. J. is the world's most-cited author among the 12,143 authors in these academic journals. Frontiers in Immunology was a prolific contributor, and Nature was the most frequently cited journal. After analysis, Cleavage of GSDMD by inflammatory caspases determines pyroptotic cell death were the top-cited articles. The analysis of keywords displayed that pyroptosis, fibrosis, and pathways were the main research hotspots and frontier directions in recent years.</p><p><strong>Conclusion: </strong>We analyzed the characteristics of published articles and drew a fundamental knowledge structure on pyroptosis and fibrosis research via bibliometric analysis. The potential mechanism between fibrosis and pyroptosis is deeply tied to the current moment. Our findings can help researchers make clear the research status and value of fibrosis and pyroptosis and provide new directions for future research as soon as possible.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"279"},"PeriodicalIF":6.3,"publicationDate":"2024-11-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11562867/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628137","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: The effects of various risk and associated factors on post-kidney transplant anemia (PTA) have not been fully compared and estimated. This meta-analysis aims to elucidate factors contributing to PTA and determine the influence of erythropoietin-stimulating agents (ESAs) on renal outcomes, thus offering potential pathways for enhanced management strategies post-transplant.
Methods: A systematic review was conducted in electronical database. Studies reporting on risk factors (with cause-effect relationships) and associated factors (without definite cause-effect relationships) of PTA, and the effects of ESAs on post-kidney transplant outcomes, were included. Pooled odds ratios (ORs) and weighted mean differences (WMDs) were analyzed using random-effects models.
Results: This systematic review encompassed 38,233 patients from 85 studies. Factors increased PTA risk included African American, older donor age, human antigen leukocyte mismatches, and low pre-transplant hemoglobin levels. Poor allograft function, high interleukine-6, Cytomegalovirus, delayed graft function, allograft rejections, immunosuppressive medications, and renin-angiotensin system blockades were associated with PTA. Native autosomal dominant polycystic kidney disease was a protective factor against PTA. Administration of ESAs with the aim of normalizing hemoglobin levels in patients with chronic allograft dysfunction slowed the decline in eGFR and reduce the risk of death, with a pooled OR of 0.36 (95% CI: 0.14 to 0.89; p = 0.040).
Conclusions: The risks and associated factors for PTA have been elucidated, underscoring the need for individualized treatment approaches. Late ESA therapy, aimed at hemoglobin normalization, suggests a renal-protective effect and reduced mortality, which should be considered in the management of PTA.
{"title":"A systematic review and meta-analysis of factors contributing to post-kidney transplant anemia and the effect of erythropoietin-stimulating agents.","authors":"Kittiphan Chienwichai, Supitchaya Phirom, Thunyatorn Wuttiputhanun, Asada Leelahavanichkul, Natavudh Townamchai, Yingyos Avihingsanon, Suwasin Udomkarnjananun","doi":"10.1186/s13643-024-02709-8","DOIUrl":"10.1186/s13643-024-02709-8","url":null,"abstract":"<p><strong>Background: </strong>The effects of various risk and associated factors on post-kidney transplant anemia (PTA) have not been fully compared and estimated. This meta-analysis aims to elucidate factors contributing to PTA and determine the influence of erythropoietin-stimulating agents (ESAs) on renal outcomes, thus offering potential pathways for enhanced management strategies post-transplant.</p><p><strong>Methods: </strong>A systematic review was conducted in electronical database. Studies reporting on risk factors (with cause-effect relationships) and associated factors (without definite cause-effect relationships) of PTA, and the effects of ESAs on post-kidney transplant outcomes, were included. Pooled odds ratios (ORs) and weighted mean differences (WMDs) were analyzed using random-effects models.</p><p><strong>Results: </strong>This systematic review encompassed 38,233 patients from 85 studies. Factors increased PTA risk included African American, older donor age, human antigen leukocyte mismatches, and low pre-transplant hemoglobin levels. Poor allograft function, high interleukine-6, Cytomegalovirus, delayed graft function, allograft rejections, immunosuppressive medications, and renin-angiotensin system blockades were associated with PTA. Native autosomal dominant polycystic kidney disease was a protective factor against PTA. Administration of ESAs with the aim of normalizing hemoglobin levels in patients with chronic allograft dysfunction slowed the decline in eGFR and reduce the risk of death, with a pooled OR of 0.36 (95% CI: 0.14 to 0.89; p = 0.040).</p><p><strong>Conclusions: </strong>The risks and associated factors for PTA have been elucidated, underscoring the need for individualized treatment approaches. Late ESA therapy, aimed at hemoglobin normalization, suggests a renal-protective effect and reduced mortality, which should be considered in the management of PTA.</p><p><strong>Systematic review registration: </strong>PROSPERO CRD42024545330.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"278"},"PeriodicalIF":6.3,"publicationDate":"2024-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11556001/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142627462","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Family caregivers of people with dementia are a distinct group due to the particularly stressful and time-intensive care situation at home. Despite these challenges, involving them in research is crucial to better understand and address their specific needs. However, little evidence exists regarding a tailored approach for researchers for this group considering their situation at home.
Methods: A scoping review will be conducted following the Joanna Briggs Institute methodological guidance, including the databases MEDLINE (PubMed), CINAHL, Scopus (Elsevier), and PsycINFO (EBSCO). The review will include family caregivers of people with dementia, regardless of age, gender, or ethnicity, who have been actively involved in research throughout the research process. Moreover, sources of evidence from any country in both English and German are eligible for inclusion. Sources will be screened by two independent reviewers. Results will be extracted using a tailored charting tool and presented in the final report according to the research questions and objectives.
Discussion: Developing a tailored approach to involve family caregivers of people with dementia in research and development has profound importance to both the scientific community and the target group itself.
Systematic review registration: Open Science Framework https://doi.org/10.17605/OSF.IO/PMZYV .
{"title":"Involvement of family caregivers in dementia care research: a scoping review protocol.","authors":"Franziska Anushi Jagoda, Julian Hirt, Claudia Mueller, Margareta Halek","doi":"10.1186/s13643-024-02696-w","DOIUrl":"10.1186/s13643-024-02696-w","url":null,"abstract":"<p><strong>Background: </strong>Family caregivers of people with dementia are a distinct group due to the particularly stressful and time-intensive care situation at home. Despite these challenges, involving them in research is crucial to better understand and address their specific needs. However, little evidence exists regarding a tailored approach for researchers for this group considering their situation at home.</p><p><strong>Methods: </strong>A scoping review will be conducted following the Joanna Briggs Institute methodological guidance, including the databases MEDLINE (PubMed), CINAHL, Scopus (Elsevier), and PsycINFO (EBSCO). The review will include family caregivers of people with dementia, regardless of age, gender, or ethnicity, who have been actively involved in research throughout the research process. Moreover, sources of evidence from any country in both English and German are eligible for inclusion. Sources will be screened by two independent reviewers. Results will be extracted using a tailored charting tool and presented in the final report according to the research questions and objectives.</p><p><strong>Discussion: </strong>Developing a tailored approach to involve family caregivers of people with dementia in research and development has profound importance to both the scientific community and the target group itself.</p><p><strong>Systematic review registration: </strong>Open Science Framework https://doi.org/10.17605/OSF.IO/PMZYV .</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"277"},"PeriodicalIF":6.3,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11552150/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-08DOI: 10.1186/s13643-024-02701-2
Shiyi Tao, Lintong Yu, Jun Li, Ji Wu, Deshuang Yang, Tiantian Xue, Lanxin Zhang, Zicong Xie, Xuanchun Huang
<p><strong>Background: </strong>Stem cell therapy is the transplantation of human cells to aid the healing of damaged or wounded tissues and cells. Only a few small-scale trials have been conducted to investigate stem cell therapy for non-ischemic dilated cardiomyopathy (DCM). We aimed to perform a systematic review and meta-analysis to assess the efficacy and safety of stem cell therapy for DCM.</p><p><strong>Methods: </strong>A comprehensive search of the databases of PubMed, Embase, Web of Science Core Collection, Cochrane Library, and ProQuest was conducted from their inception to June 30, 2024, to access randomized controlled trials (RCTs) that were centered on stem cell therapy for DCM. The primary outcome was left ventricular ejection fraction (LVEF), and the secondary outcomes included left ventricular end-diastolic dimension (LVEDD), left ventricular end-diastolic volume (LVEDV), 6-min walk test (6MWT), NYHA functional classification, quality of life (QoL) such as Minnesota Living with Heart Failure Questionnaire (MLHFQ) and Kansas City Cardiomyopathy Questionnaire (KCCQ), N-terminal pro-brain natriuretic peptide (NT-proBNP), and VO<sub>2</sub> peak. Moreover, major adverse cardiovascular events (MACEs) were also recorded. The Cochrane risk-of-bias assessment tool was used to evaluate the quality of the included RCTs, and the certainty of the evidence was assessed using the GRADE method. Sensitivity analysis was taken into consideration to determine the stability of the results. This review was registered with PROSPERO (CRD42024568912).</p><p><strong>Results: </strong>Eleven RCTs involving 637 participants were included in the quantitative analysis. The results indicated that there was a significant increase in mean LVEF (MD = 4.84, 95% CI 3.25-6.42, P < 0.00001) and considerable decrease in LVEDV (MD = - 29.51, 95% CI - 58.07 to - 0.95, P = 0.04) and NT-proBNP (MD = - 737.55, 95% CI - 904.28 to - 570.82, P < 0.00001) in DCM patients treated with stem cell therapy compared with controls. Stem cell therapy was also related to the improvement in functional capacity, as evaluated by 6MWT (MD = 44.32, 95% CI 34.70 - 53.94, P < 0.00001) and NYHA functional classification (MD = - 0.63, 95% CI - 0.96 to - 0.30, P = 0.0002). It also had positive effects on improving QoL, including significantly decreasing MLHFQ score (MD = - 16.60, 95% CI - 26.57 to - 6.63, P = 0.001) and increasing the KCCQ score (MD = 14.76, 95% CI 7.76 - 21.76, P < 0.0001). No significant differences were observed in LVEDD, VO<sub>2</sub> peak, and MACEs between the two groups. The GRADE analysis revealed that the evidence was graded from low to moderate. Sensitivity analysis of the results suggested that the results were stable.</p><p><strong>Conclusion: </strong>The systematic review and meta-analysis indicates that stem cell therapy may be an effective and safe approach to improve cardiac function and quality of life in DCM patients. Nevertheless, given the limitations of
{"title":"Stem cell therapy for non-ischemic dilated cardiomyopathy: a systematic review and meta-analysis.","authors":"Shiyi Tao, Lintong Yu, Jun Li, Ji Wu, Deshuang Yang, Tiantian Xue, Lanxin Zhang, Zicong Xie, Xuanchun Huang","doi":"10.1186/s13643-024-02701-2","DOIUrl":"10.1186/s13643-024-02701-2","url":null,"abstract":"<p><strong>Background: </strong>Stem cell therapy is the transplantation of human cells to aid the healing of damaged or wounded tissues and cells. Only a few small-scale trials have been conducted to investigate stem cell therapy for non-ischemic dilated cardiomyopathy (DCM). We aimed to perform a systematic review and meta-analysis to assess the efficacy and safety of stem cell therapy for DCM.</p><p><strong>Methods: </strong>A comprehensive search of the databases of PubMed, Embase, Web of Science Core Collection, Cochrane Library, and ProQuest was conducted from their inception to June 30, 2024, to access randomized controlled trials (RCTs) that were centered on stem cell therapy for DCM. The primary outcome was left ventricular ejection fraction (LVEF), and the secondary outcomes included left ventricular end-diastolic dimension (LVEDD), left ventricular end-diastolic volume (LVEDV), 6-min walk test (6MWT), NYHA functional classification, quality of life (QoL) such as Minnesota Living with Heart Failure Questionnaire (MLHFQ) and Kansas City Cardiomyopathy Questionnaire (KCCQ), N-terminal pro-brain natriuretic peptide (NT-proBNP), and VO<sub>2</sub> peak. Moreover, major adverse cardiovascular events (MACEs) were also recorded. The Cochrane risk-of-bias assessment tool was used to evaluate the quality of the included RCTs, and the certainty of the evidence was assessed using the GRADE method. Sensitivity analysis was taken into consideration to determine the stability of the results. This review was registered with PROSPERO (CRD42024568912).</p><p><strong>Results: </strong>Eleven RCTs involving 637 participants were included in the quantitative analysis. The results indicated that there was a significant increase in mean LVEF (MD = 4.84, 95% CI 3.25-6.42, P < 0.00001) and considerable decrease in LVEDV (MD = - 29.51, 95% CI - 58.07 to - 0.95, P = 0.04) and NT-proBNP (MD = - 737.55, 95% CI - 904.28 to - 570.82, P < 0.00001) in DCM patients treated with stem cell therapy compared with controls. Stem cell therapy was also related to the improvement in functional capacity, as evaluated by 6MWT (MD = 44.32, 95% CI 34.70 - 53.94, P < 0.00001) and NYHA functional classification (MD = - 0.63, 95% CI - 0.96 to - 0.30, P = 0.0002). It also had positive effects on improving QoL, including significantly decreasing MLHFQ score (MD = - 16.60, 95% CI - 26.57 to - 6.63, P = 0.001) and increasing the KCCQ score (MD = 14.76, 95% CI 7.76 - 21.76, P < 0.0001). No significant differences were observed in LVEDD, VO<sub>2</sub> peak, and MACEs between the two groups. The GRADE analysis revealed that the evidence was graded from low to moderate. Sensitivity analysis of the results suggested that the results were stable.</p><p><strong>Conclusion: </strong>The systematic review and meta-analysis indicates that stem cell therapy may be an effective and safe approach to improve cardiac function and quality of life in DCM patients. Nevertheless, given the limitations of ","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"276"},"PeriodicalIF":6.3,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11546504/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142628133","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-11-05DOI: 10.1186/s13643-024-02685-z
Jianbin Guan, Ningning Feng, Kaitan Yang, Haimiti Abudouaini, Peng Liu
<p><strong>Background: </strong>Ketorolac is widely utilized for postoperative pain management, including back pain after lumbar spinal surgery. Several trials have assessed the efficacy of Ketorolac alone and in combination with other analgesics such as bupivacaine, morphine, epinephrine, paracetamol, and pregabalin. However, the effects and safety profile of ketorolac in these contexts remain controversial.</p><p><strong>Objective: </strong>We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of Ketorolac administration, both as a monotherapy and in combination with other analgesics, for managing postoperative pain in adults undergoing lumbar spinal surgery.</p><p><strong>Methods: </strong>We searched PubMed, EMbase, Web of Science, EBSCO, CNKI, WanFang, VIP, and Cochrane library databases through July 2024 for randomized controlled trials (RCTs) assessing the analgesic efficacy of Ketorolac administration for postoperative pain of lumbar surgery. The meta-analysis was conducted following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statements. Data were extracted and analyzed using open-source meta-analysis software OpenMeta-Analyst, focusing on outcomes such as VAS pain scores, postoperative morphine requirements (PMR), length of hospital stay (LOS), and adverse effects, such as nausea, vomiting, pruritus, and constipation. The quality of evidence was assessed using the Jada scale.</p><p><strong>Results: </strong>Thirteen RCTs comprising a total of 938 patients were included. The methodological quality of the studies was high, with three studies scoring 5, six studies scoring 4, and four studies scoring 3 on the Jadad scale. Ketorolac significantly reduced pain compared to controls at 0-6 h, with a mean difference (MD) of - 1.42 (95% CI: - 2.03 to - 0.80; P < 0.0001), exceeding the Minimal Clinically Important Difference (MCID) of 1.2 to 2.0 points on the Visual Analog Scale (VAS), indicating clinically meaningful pain relief. During the 6-12-h period, the pain reduction was significant (MD = - 0.58; 95% CI: - 0.80 to - 0.35; P < 0.0001), though below the MCID threshold. In the 12-24-h period, Ketorolac continued to show significant pain reduction (MD = - 0.48; 95% CI: - 0.68 to - 0.28; P < 0.0001), but this reduction was also below the MCID. Heterogeneity was low in the 12-24-h period (I<sup>2</sup> = 13%), indicating consistent results across studies. There was a significant reduction in PMR (SMD = - 1.83; 95% CI = - 3.42 to - 0.23; P < 0.0001), although with considerable heterogeneity among the studies (I<sup>2</sup> = 93%, heterogeneity P < 0.01). Ketorolac administration also significantly reduced the LOS compared to controls (MD = - 0.45 days; 95% CI = - 0.74 to - 0.16; P = 0.0001), though this reduction, which is less than a full day (0.45 days), may have limited clinical significance. The findings suggest that Ketorolac ef
{"title":"The efficacy and safety of ketorolac for postoperative pain management in lumbar spine surgery: a meta-analysis of randomized controlled trials.","authors":"Jianbin Guan, Ningning Feng, Kaitan Yang, Haimiti Abudouaini, Peng Liu","doi":"10.1186/s13643-024-02685-z","DOIUrl":"10.1186/s13643-024-02685-z","url":null,"abstract":"<p><strong>Background: </strong>Ketorolac is widely utilized for postoperative pain management, including back pain after lumbar spinal surgery. Several trials have assessed the efficacy of Ketorolac alone and in combination with other analgesics such as bupivacaine, morphine, epinephrine, paracetamol, and pregabalin. However, the effects and safety profile of ketorolac in these contexts remain controversial.</p><p><strong>Objective: </strong>We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of Ketorolac administration, both as a monotherapy and in combination with other analgesics, for managing postoperative pain in adults undergoing lumbar spinal surgery.</p><p><strong>Methods: </strong>We searched PubMed, EMbase, Web of Science, EBSCO, CNKI, WanFang, VIP, and Cochrane library databases through July 2024 for randomized controlled trials (RCTs) assessing the analgesic efficacy of Ketorolac administration for postoperative pain of lumbar surgery. The meta-analysis was conducted following the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statements. Data were extracted and analyzed using open-source meta-analysis software OpenMeta-Analyst, focusing on outcomes such as VAS pain scores, postoperative morphine requirements (PMR), length of hospital stay (LOS), and adverse effects, such as nausea, vomiting, pruritus, and constipation. The quality of evidence was assessed using the Jada scale.</p><p><strong>Results: </strong>Thirteen RCTs comprising a total of 938 patients were included. The methodological quality of the studies was high, with three studies scoring 5, six studies scoring 4, and four studies scoring 3 on the Jadad scale. Ketorolac significantly reduced pain compared to controls at 0-6 h, with a mean difference (MD) of - 1.42 (95% CI: - 2.03 to - 0.80; P < 0.0001), exceeding the Minimal Clinically Important Difference (MCID) of 1.2 to 2.0 points on the Visual Analog Scale (VAS), indicating clinically meaningful pain relief. During the 6-12-h period, the pain reduction was significant (MD = - 0.58; 95% CI: - 0.80 to - 0.35; P < 0.0001), though below the MCID threshold. In the 12-24-h period, Ketorolac continued to show significant pain reduction (MD = - 0.48; 95% CI: - 0.68 to - 0.28; P < 0.0001), but this reduction was also below the MCID. Heterogeneity was low in the 12-24-h period (I<sup>2</sup> = 13%), indicating consistent results across studies. There was a significant reduction in PMR (SMD = - 1.83; 95% CI = - 3.42 to - 0.23; P < 0.0001), although with considerable heterogeneity among the studies (I<sup>2</sup> = 93%, heterogeneity P < 0.01). Ketorolac administration also significantly reduced the LOS compared to controls (MD = - 0.45 days; 95% CI = - 0.74 to - 0.16; P = 0.0001), though this reduction, which is less than a full day (0.45 days), may have limited clinical significance. The findings suggest that Ketorolac ef","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"275"},"PeriodicalIF":6.3,"publicationDate":"2024-11-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11536961/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142584384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}