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Neuro-oncology Advances 2024Meningioma clinical trials have assessed interventions including surgery, radiotherapy, and pharmacotherapy. However, agreement does not exist on what, how, and when...
BACKGROUND
Meningioma clinical trials have assessed interventions including surgery, radiotherapy, and pharmacotherapy. However, agreement does not exist on what, how, and when outcomes of interest should be measured. To do so would allow comparative analysis of similar trials. This systematic review aimed to summarize the outcomes measured and reported in meningioma clinical trials.
METHODS
Systematic literature and trial registry searches were performed to identify published and ongoing intracranial meningioma clinical trials (PubMed, Embase, Medline, CINAHL via EBSCO, and Web of Science, completed January 22, 2022). Reported outcomes were extracted verbatim, along with an associated definition and method of measurement if provided. Verbatim outcomes were deduplicated and the resulting unique outcomes were grouped under standardized outcome terms. These were classified using the taxonomy proposed by the "Core Outcome Measures in Effectiveness Trials" (COMET) initiative.
RESULTS
Thirty published articles and 18 ongoing studies were included, describing 47 unique clinical trials: Phase 2 = 33, phase 3 = 14. Common interventions included: Surgery = 13, radiotherapy = 8, and pharmacotherapy = 20. In total, 659 verbatim outcomes were reported, of which 84 were defined. Following de-duplication, 415 unique verbatim outcomes remained and were grouped into 115 standardized outcome terms. These were classified using the COMET taxonomy into 29 outcome domains and 5 core areas.
CONCLUSIONS
Outcome measurement across meningioma clinical trials is heterogeneous. The standardized outcome terms identified will be prioritized through an eDelphi survey and consensus meeting of key stakeholders (including patients), in order to develop a core outcome set for use in future meningioma clinical trials.
PubMed: 38596717
DOI: 10.1093/noajnl/vdae030 -
Journal of Clinical Medicine Sep 2023Various studies have demonstrated that low-Model for End-Stage Liver Disease (MELD) living-donor liver transplant (LDLT) recipients have better outcomes with improved... (Review)
Review
Comparing High- and Low-Model for End-Stage Liver Disease Living-Donor Liver Transplantation to Determine Clinical Efficacy: A Systematic Review and Meta-Analysis (CHALICE Study).
INTRODUCTION
Various studies have demonstrated that low-Model for End-Stage Liver Disease (MELD) living-donor liver transplant (LDLT) recipients have better outcomes with improved patient survival than deceased-donor liver transplantation (DDLT) recipients. LDLT recipients gain the most from being transplanted at MELD <25-30; however, some existing data have outlined that LDLT may provide equivalent outcomes in high-MELD and low-MELD patients, although the term "high" MELD is arbitrarily defined in the literature and various cut-off scores are outlined between 20 and 30, although most commonly, the dividing threshold is 25. The aim of this meta-analysis was to compare LDLT in high-MELD with that in low-MELD recipients to determine patient survival and graft survival, as well as perioperative and postoperative complications.
METHODS
Following PROSPERO registration CRD-42021261501, a systematic database search was conducted for the published literature between 1990 and 2021 and yielded a total of 10 studies with 2183 LT recipients; 490 were HM-LDLT recipients and 1693 were LM-LDLT recipients.
RESULTS
Both groups had comparable mortality at 1, 3 and 5 years post-transplant (5-year HR 1.19; 95% CI 0.79-1.79; -value 0.40) and graft survival (HR 1.08; 95% CI 0.72, 1.63; -value 0.71). No differences were observed in the rates of major morbidity, hepatic artery thrombosis, biliary complications, intra-abdominal bleeding, wound infection and rejection; however, the HM-LDLT group had higher risk for pulmonary infection, abdominal fluid collection and prolonged ICU stay.
CONCLUSIONS
The high-MELD LDLT group had similar patient and graft survival and morbidities to the low-MELD LDLT group, despite being at higher risk for pulmonary infection, abdominal fluid collection and prolonged ICU stay. The data, primarily sourced from high-volume Asian centers, underscore the feasibility of living donations for liver allografts in high-MELD patients. Given the rising demand for liver allografts, it is sensible to incorporate these insights into U.S. transplant practices.
PubMed: 37762738
DOI: 10.3390/jcm12185795 -
International Journal of Gynecological... Oct 2023This analysis aimed to better define the relationship between progression-free survival and overall survival in adult patients with ovarian cancer (including fallopian...
OBJECTIVES
This analysis aimed to better define the relationship between progression-free survival and overall survival in adult patients with ovarian cancer (including fallopian tube or primary peritoneal cancer) following primary cytoreductive surgery or interval cytoreductive surgery.
METHODS
A systematic literature review was carried out across the Medline, Embase, and Cochrane Central databases on 7 July 2020 (date limits 1 January 2011 to 7 July 2020) to identify studies with the following eligibility criteria: clinical trials/observational studies including >200 patients with ovarian cancer aged ≥18 years, evaluating overall survival/progression-free survival following cytoreductive surgery by residual disease status in the United States, Europe, Japan, or China. Weighted linear regression models were used to assess any correlation between median progression-free survival and overall survival, and between logHR for progression-free survival and logHR for overall survival. Risk of bias was assessed for all included studies.
RESULTS
Of the 50 studies reported, 43 were observational studies (41 retrospective and two prospective cohort studies), and seven were reporting for randomized clinical trials-of which four were retrospective data analyses. For analyses of the relationship between overall survival and progression-free survival, 21 studies were eligible. The weighted linear regression model showed a strong positive association between the two survival endpoints. Goodness-of-fit analysis measured the adjusted R as 0.84 (p<0.001); a positive association was also observed between logHRs for overall survival and progression-free survival in the included studies.
CONCLUSIONS
Median progression-free survival was predictive of median overall survival. This correlation between progression-free survival and overall survival after primary treatment for ovarian cancer highlights the validity of progression-free survival as a primary endpoint. Observational studies contributed most data, with limited information on disease stage and histology.
Topics: Adult; Humans; Female; Adolescent; Progression-Free Survival; Cytoreduction Surgical Procedures; Retrospective Studies; Prospective Studies; Ovarian Neoplasms
PubMed: 37643825
DOI: 10.1136/ijgc-2023-004487 -
Frontiers in Psychiatry 2023Considering the growing number of gamers worldwide and increasing public concerns regarding the negative consequences of problematic gaming, the aim of the present... (Review)
Review
BACKGROUND AND AIMS
Considering the growing number of gamers worldwide and increasing public concerns regarding the negative consequences of problematic gaming, the aim of the present systematic review was to provide a comprehensive overview of gaming disorder (GD) by identifying empirical studies that investigate biological, psychological, and social factors of GD using screening tools with well-defined psychometric properties.
MATERIALS AND METHODS
A systematic literature search was conducted through PsycINFO, PubMed, RISS, and KISS, and papers published up to January 2022 were included. Studies were screened based on the GD diagnostic tool usage, and only five scales with well-established psychometric properties were included. A total of 93 studies were included in the synthesis, and the results were classified into three groups based on biological, psychological, and social factors.
RESULTS
Biological factors ( = 8) included reward, self-concept, brain structure, and functional connectivity. Psychological factors ( = 67) included psychiatric symptoms, psychological health, emotion regulation, personality traits, and other dimensions. Social factors ( = 29) included family, social interaction, culture, school, and social support.
DISCUSSION
When the excess amount of assessment tools with varying psychometric properties were controlled for, mixed results were observed with regards to impulsivity, social relations, and family-related factors, and some domains suffered from a lack of study results to confirm any relevant patterns.
CONCLUSION
More longitudinal and neurobiological studies, consensus on a diagnostic tool with well-defined psychometric properties, and an in-depth understanding of gaming-related factors should be established to settle the debate regarding psychometric weaknesses of the current diagnostic system and for GD to gain greater legitimacy in the field of behavioral addiction.
PubMed: 37533885
DOI: 10.3389/fpsyt.2023.1200230 -
Diabetology & Metabolic Syndrome Jan 2024Randomized controlled trials have found that once-weekly insulin resulted in greater glycemic control compared to once-daily insulin in patients with type 2 diabetes.... (Review)
Review
BACKGROUND
Randomized controlled trials have found that once-weekly insulin resulted in greater glycemic control compared to once-daily insulin in patients with type 2 diabetes. However, no direct comparisons have been made between different types of once-weekly insulin thus far. This systematic review and network meta-analysis aimed to evaluate the effect of the two most advanced once-weekly insulin analogues, namely insulin icodec and insulin Fc, in patients with type 2 diabetes.
METHODS
We conducted a thorough search in the databases PubMed, Embase, and the Cochrane Central Register of Controlled Trials. The search included articles published from the beginning to October 10, 2023, with no language limitations. Our aim was to conduct a systematic review of randomized controlled trials that investigated the effectiveness and safety of once-weekly insulin in individuals with type 2 diabetes. Our primary outcome was to evaluate excellent glycemic control, defined as patients achieving glycated hemoglobin levels below 7%.
RESULTS
We identified a total of 7 trials involving 2829 patients. The results showed that once-weekly insulin icodec is more effective than once-weekly insulin Fc (RR 1.59 [95% CI 1.08-2.38]), once-daily degludec (RR 1.43 [95% CI 1.14-1.83]), and once-daily glargine (RR 1.15 [95% CI 1.00-1.41]). Moreover, the incidence of severe hypoglycemia was lower with once-weekly insulin icodec compared to once-daily degludec (RR 0.00016 [95% CI 0 to 0.41]). However, no significant difference in the incidence of severe hypoglycemia was observed between once-weekly insulin icodec and once-daily glargine (RR 0.39 [95% CI 0.03 to 4.83]).
CONCLUSIONS
In patients with type 2 diabetes, once-weekly insulin icodec achieved superior glycemic control compared to once-weekly insulin Fc, with no significant difference in the occurrence of hypoglycemia. The ranking probability results have shown that one weekly icodec seems to be the preferred option in patients with type 2 diabetes.
TRIAL REGISTRATION
PROSPERO Identifier: CRD42023470894.
PubMed: 38172995
DOI: 10.1186/s13098-023-01240-5 -
Journal of Intensive Care Nov 2023The efficacy of therapeutic drug monitoring (TDM)-based antimicrobial dosing optimization strategies on pharmacokinetics/pharmacodynamics and specific drug properties...
BACKGROUND
The efficacy of therapeutic drug monitoring (TDM)-based antimicrobial dosing optimization strategies on pharmacokinetics/pharmacodynamics and specific drug properties for critically ill patients is unclear. Here, we conducted a systematic review and meta-analysis of randomized controlled trials to evaluate the effectiveness of TDM-based regimen in these patients.
METHODS
Articles from three databases were systematically retrieved to identify relevant randomized control studies. Version two of the Cochrane tool for assessing risk of bias in randomized trials was used to assess the risk of bias in studies included in the analysis, and quality assessment of evidence was graded using the Grading of Recommendations Assessment, Development, and Evaluation approach. Primary outcome was the 28-day mortality and secondary outcome were in-hospital mortality, clinical cure, length of stay in the intensive care unit (ICU) and target attainment at day 1 and 3.
RESULTS
In total, 5 studies involving 1011 patients were included for meta-analysis of the primary outcome, of which no significant difference was observed between TDM-based regimen and control groups (risk ratio [RR] 0.94, 95% confidence interval [CI]: 0.77-1.14; I = 0%). In-hospital mortality (RR 0.96, 95% CI: 0.76-1.20), clinical cure (RR 1.23, 95% CI: 0.91-1.67), length of stay in the ICU (mean difference 0, 95% CI: - 2.18-2.19), and target attainment at day 1 (RR 1.14, 95% CI: 0.88-1.48) and day 3 (RR 1.35, 95% CI: 0.90-2.03) were not significantly different between the two groups, and all evidence for the secondary outcomes had a low or very low level of certainty because the included studies had serious risk of bias, variation of definition for outcomes, and small sample sizes.
CONCLUSION
TDM-based regimens had no significant efficacy for clinical or pharmacological outcomes. Further studies with other achievable targets and well-defined outcomes are required.
TRIAL REGISTRATION
Clinical trial registration; PROSPERO ( https://www.crd.york.ac.uk/prospero/ ), registry number: CRD 42022371959. Registered 24 November 2022.
PubMed: 37936203
DOI: 10.1186/s40560-023-00699-8 -
Beyoglu Eye Journal 2024Micro-pulse cyclophotocoagulation (MP-CPC) represents the latest iteration of minimally invasive laser procedures aimed at reducing intraocular pressure (IOP) through... (Review)
Review
OBJECTIVES
Micro-pulse cyclophotocoagulation (MP-CPC) represents the latest iteration of minimally invasive laser procedures aimed at reducing intraocular pressure (IOP) through the disruption of pigmented ciliary body epithelium. This systematic review aims to assess the efficacy and safety profile of the MP-CPC procedure in comparison to CW-CPC for the treatment of glaucoma.
METHODS
We initiated a search on PubMed, ScienceDirect, and the Cochrane Library databases for studies that compared micro-pulse and traditional CW-CPC in terms of their efficacy and safety profiles. We employed medical subject headings terms and keywords such as "cyclophotocoagulation," "cyclodestructive," "photocoagulation," "CPC," "micropulse," "micro-pulse," and "glaucoma" within the timeframe from 2015 to 2023. We assessed the success rate, IOP reduction, antiglaucoma medications, and complications of MP-CPC and CW-CPC.
RESULTS
We included six articles in this study, comprising two randomized controlled trials, three retrospective, and one prospective cohort, published between 2015 and 2023. Five out of six reported a significant reduction in IOP for both procedures with comparable success rates observed in MP-CPC compared to CW-CPC. One article reported an increase in IOP in MP-CPC. Both groups reported a decrease in the number of antiglaucoma medications, while one study reported an increase in medications in both MP-CPC and CW-CPC groups. Complication rates were lower in the MP-CPC group with two articles reporting a significant decrease compared to the CW-CPC group.
CONCLUSION
MP-CPC has shown promising results in the treatment of glaucoma in the adult population. With comparable results in IOP reduction and fewer instances of serious ocular complications, MP-CPC may open new possibilities for the use of cyclophotocoagulation procedures in the earlier stages of glaucoma. However, its efficacy in the pediatric population and for neovascular glaucoma remains less defined, thus warranting further studies to establish optimal laser parameters for different types of glaucoma and specific populations of glaucoma patients.
PubMed: 38504958
DOI: 10.14744/bej.2024.47123 -
Scientific Reports Feb 2024The association between social frailty and adverse health outcomes, especially mortality and functional disability, which are essential health outcomes, has not been... (Meta-Analysis)
Meta-Analysis
The association between social frailty and adverse health outcomes, especially mortality and functional disability, which are essential health outcomes, has not been systematically summarized or meta-analyzed. In this study, we conducted a systematic review and meta-analysis of the impact of social frailty on all-cause mortality and functional disability, while addressing the components of social frailty. In this study, social frailty was operationally defined in alignment with the previous literature, as follows: "a state of increased vulnerability to the interactive back-and-forth of the community, including general resources, social resources, social behaviors, and needs." Hazard ratios or odds ratios described in each selected literature were used as the meta-analytic results. Considering the impact of social frailty on all-cause mortality, the hazard ratio was 1.96 (95% CI 1.20-3.19), indicating a significant association between the two but high heterogeneity. The hazard and odds ratios for the impact of social frailty on functional disability were 1.43 (95% CI 1.20-1.69) and 2.06 (95% CI 1.55-2.74), respectively. A significant association was found between social frailty and functional disability; both hazard and odds ratios were found, and low heterogeneity between these articles was observed. These results highlight the importance of assessing social frailty using more standardized methods and examining its effects on various health outcomes.
Topics: Humans; Aged; Frailty; Frail Elderly; Social Behavior; Odds Ratio; Proportional Hazards Models
PubMed: 38341512
DOI: 10.1038/s41598-024-53984-3 -
Journal of Asthma and Allergy 2023Strong associations between early antibiotic exposure and increased risk of childhood allergies have been established. Antibiotics have the potential to induce microbial... (Review)
Review
BACKGROUND
Strong associations between early antibiotic exposure and increased risk of childhood allergies have been established. Antibiotics have the potential to induce microbial dysbiosis that may be linked to allergic conditions. This review examines the limited available evidence on the associations between adult antibiotic use, microbial dysbiosis and atopic conditions.
METHODS
A systematic literature search was conducted using PubMed and Embase for relevant studies, published between 01-01-2000 and 08-17-2022. We searched for associations between antibiotic use, microbial dysbiosis, and allergic conditions in adults, defined as over 13 years of age for the purposes of this review.
RESULTS
Twenty-one studies were analyzed, with the inclusion of four narrative reviews as scarce relevant literature was found when stricter selection criteria were employed. Relevant studies predominantly focused on asthma. Significant microbial differences were observed in most measures between healthy subjects and subjects with allergic conditions. However, no system-wise and strain-wise associations were evident. Notably, at the phyla level, the Bacillota and Pseudomonadota phyla were associated with asthmatics, while the Actinobacteria phylum was linked to healthy controls. Asthmatics tends to reflect upregulation in the Bacillota and Pseudomonadota phyla in both airway and gut microbiomes.
CONCLUSION
No compelling evidence could be found between adult antibiotic exposure, consequent microbial dysbiosis, and allergic conditions in adults. Our review is limited by scarce literature and therefore remains inconclusive. However, potential implications of antibiotic use impacting on allergic conditions justify additional research and heightened pharmacovigilance in this area.
PubMed: 37822520
DOI: 10.2147/JAA.S401755 -
Journal of Clinical Anesthesia Nov 2023The objective of this systematic review was to estimate the relative risk of prolonged times to tracheal extubation with desflurane versus sevoflurane or isoflurane.... (Meta-Analysis)
Meta-Analysis Review
The objective of this systematic review was to estimate the relative risk of prolonged times to tracheal extubation with desflurane versus sevoflurane or isoflurane. Prolonged times are defined as ≥15 min from end of surgery (or anesthetic discontinuation) to extubation in the operating room. They are associated with reintubations, naloxone and flumazenil administration, longer times from procedure end to operating room exit, greater differences between actual and scheduled operating room times, longer times from operating room exit to next case start, longer durations of the workday, and more operating room personnel idle while waiting for extubation. Published randomized clinical trials of humans were included. Generalized pivotal methods were used to estimate the relative risk of prolonged extubation for each study from reported means and standard deviations of extubation times. The relative risks were combined using DerSimonian-Laird random effects meta-analysis with Knapp-Hartung adjustment. From 67 papers, there were 78 two-drug comparisons, including 5167 patients. Studies were of high quality (23/78) or moderate quality (55/78), the latter due to lack of blinding of observers to group assignment and/or patient attrition because patients were extubated after operating room exit. Desflurane resulted in a 65% relative reduction in the incidence of prolonged extubation compared with sevoflurane (95% confidence interval 49% to 76%, P < .0001) and in a 78% relative reduction compared with isoflurane (58% to 89%, P = .0001). There were no significant associations between studies' relative risks and quality, industry funding, or year of publication (all six meta-regressions P ≥ .35). In conclusion, when emergence from general anesthesia with different drugs are compared with sevoflurane or isoflurane, suitable benchmarks quantifying rapidity of emergence are reductions in the incidence of prolonged extubation achieved by desflurane, approximately 65% and 78%, respectively. These estimates give realistic context for interpretation of results of future studies that compare new anesthetic agents to current anesthetics.
Topics: Humans; Isoflurane; Sevoflurane; Desflurane; Risk; Airway Extubation; Anesthetics, Inhalation; Methyl Ethers; Anesthesia Recovery Period
PubMed: 37481911
DOI: 10.1016/j.jclinane.2023.111210