Single-arm Meta-analysis Research Articles

Effect of Antithyroid Drugs Treatment Duration on The Remission Rates of Graves' Disease in Children and Adolescents: A Single-Arm Meta-Analysis and Systematic Review.

Antithyroid drugs (ATDs) are the preferred treatment option for Graves' disease (GD), yet there is a lack of systematic evaluations studying the relationship between treatment duration and therapeutic outcomes. This study aims to assess the remission rate (RR) in children with GD under ATDs therapy and to conduct an analysis of associated factors. Systematically searched PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure and Wanfang database, with a search time limit from the establishment of the database to 23 November 2023. The primary outcome was the RR. The pooled RR was calculated and subgroup comparisons were performed. Meta-analysis was conducted using R Studio 2023.09.0 + 463 software. The study incorporated a total of 19 research projects, which collectively involved 3359 paediatric patients diagnosed with GD (comprising 2600 girls and 759 boys). The overall RR for paediatric GD treated with ATDs was 25.4% (95% Confidence Interval [CI]: 20.7%, 30.1%). The pooled RR following treatment durations of < 2 years, 2-5 years, and > 5 years were respectively 15.5%, 24.1% and 33.0%. Meta-regression results indicated that the duration of treatment and follow-up duration were significant sources of high heterogeneity among the studies. Specifically, for every additional year of ATDs treatment, there was an increase in the RR by 3.8% (Coefficient = 3.8%, 95% CI: 0.6%, 7.0%, p < 0.01). The overall RR for the treatment of paediatric GD with ATDs is 25.4%, and prolonging the treatment course can indeed lead to an increased RR.

Multidisciplinary and multimodal interventions for depressive and anxiety disorders: A single-arm meta-analysis.

Multidisciplinary and multimodal interventions for depressive and anxiety disorders: A single-arm meta-analysis.

Unlocking the future: machine learning models for predicting in-hospital mortality after transcatheter aortic valve replacement: a single-arm meta-analysis

Abstract Background Transcatheter aortic valve replacement (TAVR) continues to be increasingly performed. While machine learning has demonstrated utility in predicting adverse outcomes in various cardiovascular procedures, its effectiveness in predicting in-hospital mortality in TAVR remains uncertain. Purpose We aimed to examine the accuracy of machine learning in predicting in-hospital mortality in TAVR. Methods We searched PubMed and Cochrane databases up to February 2024 for observational studies assessing the diagnostic accuracy of machine learning for predicting in-hospital mortality in TAVR. Extracted data included study characteristics, patient demographics, type of predictive model used, and area under the receiver operating characteristic curves (AUC). Predictive accuracy was assessed by pooling AUC of machine-learning models across studies. AUC values ranging from 0.80 to 0.90, 0.70 to 0.80, 0.60 to 0.70, and 0.50 to 0.60 corresponded to excellent, good, fair, and poor discrimination ability, respectively (1). We used a random effects model to estimate the overall effect size with a 95% confidence interval (CI). Heterogeneity was evaluated with the I2 test.We conducted subgroup analyses based on the type of machine-learning model utilized to assess for any potential differences in predictive accuracy. Results A total of three studies were identified, comprising a study population of 70,714 patients. Across studies, eight machine learning models were utilized, consisting of three artificial neural network models, one logistic regression model, one naive Bayes model, two random forest models, and one support vector machine model. Pooled AUC showed excellent accuracy of machine learning in predicting in-hospital mortality in TAVR (0.92; 95% CI 0.90 - 0.95). Subgroup analyses revealed similar yet excellent accuracy across all types of machine learning models utilized: artificial neural network (0.92; 95% CI 0.86-0.99), logistic regression (0.92; 95% CI 0.89-0.95), naive Bayes (0.90; 95% CI 0.88-0.92), random forest (0.94; 95% CI 0.87-1.00), and support vector machine (0.94; 95% CI 0.91-0.96). Conclusion Our study suggests that utilizing machine learning can accurately predict in-hospital mortality in TAVR. Operators of TAVR procedures may benefit from incorporating machine learning prediction models in their clinical practice. Further exploration of machine learning on outcomes in TAVR is needed to verify our findings.

Unique regional risk profiles and cardiovascular outcomes of patients with acute coronary syndrome in the absence of standard modifiable risk factors: a systematic review and meta-analysis

Abstract Background With differences in prevalence, risk profile, cardiovascular complications, and mortality of patients with acute coronary syndrome (ACS) in the absence of standard modifiable risk factors (SMuRF-less) worldwide, this study examines the regional differences and the unique risk profiles of this often-understudied group of patients. Purpose We hypothesize that differences in non-traditional risk factor profiles may lead to unique ACS-related presentations, complication rates, and secondary preventative strategies across regions. Hence this study was undertaken to assess the cross-regional comparisons of patient characteristics, risk profile, angiographic characteristics that may provide insights into disparate cardiovascular outcomes observed in the SMuRF-less ACS population. Methods Medline and Embase databases were searched in November 2022 to identify relevant literature relating to the prevalence of risk factors in SMuRF-less patients with ACS. A single-arm meta-analysis of proportion and means was conducted on baseline and presentation characteristics, outcomes and complications, management, and risk factors in SMuRF-less ACS patients, stratified according to geographical region (Asia-Pacific, Europe, and North America). Risk of bias was assessed using the Newcastle-Ottawa scale. Results A total of 25 studies comprising of 1,393,184 individuals with ACS were included, of which 242,929 patients were SMuRF-less. Within this SMuRF-less ACS group, mortality rates were similar across the regions (Asia-Pacific:15.8%, Europe:17.5%, p=0.861), cardiac arrest (6.3%, 95%CI:2.3% to 16.3%, p=0.001) and major bleeding (5.2%, 95%CI:2.9% to 9.2%, p=0.001) were more prevalent in Asia-Pacific, and heart failure more common in Europe (21.7%, 95%CI:18.2% to 25.7%, p&amp;lt;0.001). Prevalence of chronic obstructive lung disease (21.4%, 95%CI:21.2% to 21.6%, p&amp;lt;0.001) and peripheral artery disease (3.8%, 95%CI:3.1% to 4.7%, p=0.001) were highest in SMuRF-less ACS patients from North America, chronic liver disease most prevalent in those from Asia-Pacific (3.5%, 95%CI:2.2% to 5.6%, p&amp;lt;0.001) and family history of coronary artery disease highest in SMuRF-less ACS patients from Europe (25.2%, 95%CI:24.8% to 25.7%, p=0.024). Significantly lower rates of guideline-directed medical therapy prescriptions were observed for SMuRF-less ACS patients in Asia-Pacific compared to other regions. Conclusion This regional analysis highlights the different risk profiles, cardiovascular outcomes, and specific needs of individuals presenting with ACS in the absence of cardiovascular risk factors, across Asia-Pacific, Europe, and North America. Whilst unravelling novel pathomechanistic pathways of atherosclerosis will prove beneficial on a global scale, understanding the unique regional profile of these individuals will aid policymakers strategize effective and tailored clinical pathways in the management of SMuRF-less ACS.Graphical AbstractKey Outcomes

Treatment-free remission after discontinuation of tyrosine kinase inhibitors in patients with chronic myeloid leukemia in the chronic phase: a systematic review and meta-analysis

BackgroundTreatment-free remission (TFR) is a new long-term goal for treating selected patients with chronic myeloid leukemia in the chronic phase (CML-CP). Still, the appropriate group in which TFR can be attempted and the factors influencing it have not yet been identified. This meta-analysis aimed to explore TFR in CML-CP patients who achieved a deep molecular response (DMR) before Tyrosine kinase inhibitors (TKIs) discontinuation and to explore possible factors influencing TFR and the safety of discontinuation.MethodsWe performed a systematic review and single-arm meta-analysis with a systematic search of published literature up to September 2023 in PubMed, Embase, Web of Science, Cochrane Library, and CNKI databases. The assessment was performed using the MINORS scale. Random-effects models were used to calculate outcome metrics, including overall mean TFR rates at 12 and 24 months and subgroup differences. Data synthesis and analysis were done by Stata17.0 software.ResultsA total of 19 single-arm trials involving 2336 patients were included in this meta-analysis, with an overall mean TFR rate of 59% [95CI:0.56–0.63] at 12 months and 55% [95CI:0.52–0.59] at 24 months, and no CML-related deteriorations or deaths reported during the TFR period. Our subgroup analysis showed that better TFR was associated with prior interferon therapy (P = 0.003), and molecular response depth MR5.0 (P = 0.020).ConclusionOur study demonstrated that prior interferon therapy and attainment of a molecular response depth of MR5.0 or greater were associated with higher TFR rates, with patients who attained MR5.0 or greater achieving a TFR rate of up to 62% in the second year after TKI discontinuation. Considering the high heterogeneity of the included trials, the above influences still require further validation and more detailed subgroup analysis in future discontinuation trials.Systematic review registration:https://www.crd.york.ac.uk/prospero/ (Registration No. CRD42023471334).

The efficacy and safety of intravenous tocilizumab to treat Graves' ophthalmopathy: A systematic review and single-arm meta-analysis.

This study aims to evaluate the efficacy and safety of intravenous tocilizumab (TCZ) in the treatment of Graves' ophthalmopathy (GO). A comprehensive search was conducted across the Web of Science, PubMed, Embase, Cochrane Library, World Health Organization International Clinical Trials Registry Platform, and https://ClinicalTrials.gov databases from inception to April 2024. Randomized controlled trials (RCTs) and cohort studies that utilized intravenous TCZ for treating GO were included. Twelve studies encompassing 219 patients with active, steroid-resistant GO were analyzed. The meta-analysis demonstrated significant improvements in Clinical Activity Score (CAS) response (effect size [ES] = 0.98, 95% confidence interval [CI]: 0.93-1.00), proptosis response (ES = 0.50, 95% CI: 0.27-0.73), and diplopia response (ES = 0.48, 95% CI: 0.24-0.74). The ES for adverse events was 0.27 (95% CI: 0.22-0.33), with only three severe cases necessitating treatment discontinuation, and a low reactivation rate (ES = 0.01, 95% CI: 0.00-0.04). TCZ treatment led to a mean CAS reduction of 4.60 points (95% CI: 3.88-5.32) across 10 studies, a mean proptosis reduction of 2.04 mm (95% CI: 1.42-2.65) across 7 studies, and a mean decrease in thyroid-stimulating hormone receptor antibodies (TRAb) levels of 10.62 IU (95% CI: 4.67-10.62) across 5 studies. This meta-analysis provides robust evidence supporting the efficacy and safety of intravenous TCZ in patients with GO who are resistant to glucocorticoid therapy. The results highlight TCZ's comparable efficacy to glucocorticoids and suggest that TCZ could significantly expand clinical management options for GO. In the future, more high-quality, large-scale RCTs are still needed to confirm these findings.

Stereotactic radiosurgery for recurrent/residual nonfunctioning pituitary adenoma: a single-arm systematic review and meta-analysis.

Nonfunctioning pituitary adenomas (NFPAs) are a significant subtype of pituitary tumors, accounting for 30% of all pituitary tumors and 10-20% of intracranial tumors. The primary treatment for NFPAs is resection, but complete resection is often challenging due to the tumor's proximity to critical structures, leading to frequent recurrences. Stereotactic radiosurgery (SRS) has emerged as a viable treatment option for recurrent or residual NFPAs, but its long-term efficacy and safety profile require further investigation. This systematic review followed PRISMA guidelines and included studies published up to February 2024. We searched MEDLINE, Embase, and Cochrane databases for studies evaluating SRS for recurrent/residual NFPAs. Inclusion criteria focused on studies reporting outcomes and complications of SRS, while exclusion criteria omitted case reports, case series, and non-English studies. Data extracted included demographic details, dosimetry parameters, and follow-up durations. The risk of bias was assessed using the ROBINS-I tool, and statistical analyses were performed using single-arm meta-analyses. A total of 24 studies involving 3,781 patients were included. The mean follow-up duration was 60months. Tumor control was achieved in approximately 92.3% of patients. The risk of developing hypopituitarism post-SRS was 13.62%, while the risk for panhypopituitarism was 2.55%. New visual field deficits occurred in 3.94% of patients. Cranial nerve deficits were rare, with event rates below 1% for CN III, CN V, and CN VI. SRS is effective in managing recurrent or residual NFPAs, achieving high tumor control rates. However, the risk of hypopituitarism remains a significant concern, necessitating regular endocrinological monitoring. While generally safe, the potential for new visual field deficits and other cranial nerve deficits must be considered. SRS remains a valuable treatment option, but clinicians should be aware of its potential complications.

Efficacy and safety of pasireotide treatment in acromegaly: A systematic review and single arm meta-analysis.

Acromegaly is a rare chronic endocrine disorder associated with significant comorbidities. Many patients fail to achieve biochemical control with current medical therapies, including surgery and first-generation somatostatin ligands (fg-SRLs). We aimed to perform a systematic review and single-arm meta-analysis to evaluate the efficacy of the multi-receptor somatostatin ligand pasireotidein patients with active or uncontrolled acromegaly. We systematically searched PubMed, Embase, and Cochrane databases for studies that assessed the efficacy of pasireotide in patients withacromegaly and reported the outcomes of (1)biochemical control and its composite indicators; (2)normalized IGF-1 level and (3)low GH level.For the statistical analysis, we used R software. We included nine studies with a total of 590 patients: four clinical trials and five observational cohorts. 82.2% of the overall population consisted of inadequately controlled acromegaly patients. After a follow-up of 12months, the pooled biochemical control rate was 26.50% (95% CI 14.87-42.66). The prevalence of normalized IGF-1 and low GH levels was 36.27% (95% CI 29.15-43.39) and 34.76% (95% CI 24.58-44.95), respectively. Additionally, biochemical response rates were sustained throughout the extension phase of these studies. In a pooled analysis including four studies with extension phase results, the prevalence of biochemical control rate was 29.03% (95% CI 11.49-46.58) with 76 events out of 281 patients. The most commonly reported adverse events were gastrointestinal disturbances in 31.26% (95% CI 7.44-72.01) and hyperglycemia in 29.55% (95% CI 21.80-37.29) of patients. The incidence of new-onset diabetes mellitus significantly increased after pasireotide treatment, with a rate of 23.36% (95% CI 19.58-27.13). Pasireotide demonstrates biochemical control in patients with active or uncontrolled acromegaly. Although a high rate of hyperglycemic adverse events and diabetes mellitus related to the treatment were observed, most of them were manageable.

Efficacy and safety of RET-kinase inhibitors in RET-altered thyroid cancer: A single arm meta-analysis

Efficacy and safety of RET-kinase inhibitors in RET-altered thyroid cancer: A single arm meta-analysis

Exploring the benefits of astaxanthin as a functional food ingredient: Its effects on oxidative stress and reproductive outcomes in women with PCOS - A systematic review and single-arm meta-analysis of randomized clinical trials.

Polycystic ovary syndrome (PCOS) is a prevalent gynecological-endocrinological disorder characterized by hyperandrogenism, menstrual irregularities, and metabolic disturbances. Recent research has highlighted the role of oxidative stress and chronic inflammation in exacerbating PCOS symptoms and impeding reproductive outcomes. Astaxanthin, a potent antioxidant found in marine organisms, has been suggested as a potential therapeutic intervention due to its ability to reduce oxidative stress and inflammation. This meta-analysis systematically reviews randomized controlled trials assessing the impact of astaxanthin supplementation on oxidative stress and reproductive outcomes in women with PCOS. Data from four trials were analyzed, focusing on markers of oxidative stress and reproductive health metrics. The meta-analysis utilized fixed and random-effects models to synthesize results, with heterogeneity assessed using Chi-square and I2 statistics. The findings indicate that while astaxanthin significantly improves markers of total antioxidant capacity (TAC) in follicular fluid, it does not show a consistent effect on other oxidative stress biomarkers such as malondialdehyde (MDA), catalase (CAT), or superoxide dismutase (SOD). Reproductive outcomes, including oocyte quality and the number of high-quality embryos, showed moderate improvements, although effects on fertilization rates and pregnancy outcomes were insignificant. The analysis highlights variability in study designs and dosing, suggesting a need for further research with standardized protocols and larger sample sizes. Future studies should focus on determining optimal dosing, exploring mechanistic pathways, and investigating the combined effects of astaxanthin with other interventions. Longitudinal studies are needed to assess long-term benefits and safety, and personalized approaches could enhance treatment efficacy for individualswithPCOS.

Supplemental Material for Multidisciplinary and Multimodal Interventions for Depressive and Anxiety Disorders: A Single-Arm Meta-Analysis

Supplemental Material for Multidisciplinary and Multimodal Interventions for Depressive and Anxiety Disorders: A Single-Arm Meta-Analysis

Efficacy and safety of PARPis combined with an ICIs for advanced or metastatic triple-negative breast cancer: a single-arm meta-analysis.

Although the intervention for triple-negative breast cancer (TNBC) patients has improved and survival time has increased, the combination of immune checkpoint inhibitors(ICIs) and PARP inhibitors (Poly ADP-Ribose Polymerase inhibitors, PARPis) is still controversial. Previous studies revealed that the combined use of ICIs and PARPis led to increased antitumor activity. However, most of these combined regimens are nonrandomized controlled trials with small sample sizes. The purpose of this meta-analysis was to evaluate the efficacy and safety of ICIs combined with PARPis in patients with advanced or metastatic TNBC. The PubMed, Embase, Cochrane Library and Web of Science databases were systematically searched. The results including the objective remission rate (ORR), disease control rate (DCR), progression-free survival (PFS) and adverse events (AEs), were subjected to further analysis. Four studies involving 110 subjects were included in this meta-analysis. The combined ORR and DCR were 23.6% and 53.6%, respectively; while the ORR and DCR of BRCAmut patients were 38.1% and 71.4%, respectively. The median PFS of the patients was 4.29 months. As for safety, the most common AEs were nausea (49.0%), anemia (44.3%) and fatigue (40.6%). Most of them were grade 1 or 2, and the incidence of adverse events ≥ III was obviously low. Except for anemia, the incidence of AEs ≥ III was < 10%. This meta-analysis revealed that the combination of ICIs and PARPis has good efficacy and safety for advanced or metastatic TNBC patients.

How safe is high-intensity focused ultrasound? An intriguing solution for obstetric and gynecological diseases: A systematic review.

High-intensity focused ultrasound (HIFU) is a non-surgical and noninvasive treatment modality that depends on external ultrasound energy sources that induce focused mass ablation and protein degeneration in the treatment area via thermal energy penetration under the intact skin. We aim in our study to collectively evaluate the safety of HIFU for the treatment of different obstetric and gynecological diseases in the literature. We searched PubMed, Scopus, and Science Direct databases, without restriction on date or language, from the inception of these databases until January 20, 2024. We also examined the references of the included studies in the Mendeley archive for eligible articles. We found a total of 706 studies. After the screening and selection process, 56 participants were included. Our dichotomous outcomes were pooled in our single-arm meta-analysis as risk ratio (RR) and with 95% confidence interval (CI) while our continuous outcomes were pooled as mean change and 95% CIs. Fixed- or random-effects models were applied depending on the heterogeneity detected. Our systematic review and meta-analysis included 56 studies including 11.740 patients. Depending on the Society of Interventional Radiology (SIR) classification for adverse effects. The results of this meta-analysis for the type A category that did not require clinical intervention found that pain in the treatment site estimated RR with 95% CI: 0.61 (0.33, 0.89), abnormal vaginal discharge 0.16 (0.073, 0.24), low-grade fever (<38 °C) 0.005 (0.002, 0.009). Sensory abnormalities of the lower limbs were examined in 3390 individuals and observed in only 19 patients who experienced gradual relief of symptoms within one month after treatment. Regarding SIR type B, 99 of a total of 6.437 patients had small vesicles and superficial burns with pooled RR and 95% CI: 0.012 (0.007, 0.018). In terms of groin or perianal and lower abdominal pain, our RRs with 95% CIs were 0.1 (0.067, 0.13) and 0.38 (0.25, 0.51). However, vaginal bleeding was detected in only 32 out of a total of 3.017. Major adverse events like lumber disc herniation, thrombocytopenia, and renal failure, were unmentionable. Additionally, our included studies did not record any deaths. HIFU, either alone or in combination with oxytocin or any other enhancing agent, is safe for patients with different gynecological and obstetric diseases. In terms of efficacy, it showed promising results compared with traditional treatment lines. To our knowledge, we are the first and most comprehensive meta-analysis in the literature that has studied the different safety outcomes related to HIFU as a treatment modality for different obstetric and gynecological diseases with a very large sample size, making our evidence strong and less attributed to errors.

1030P Survival rates in high-risk neuroblastoma patients undergoing anti-GD2 immunotherapy: A single arm meta-analysis and systemic review

1030P Survival rates in high-risk neuroblastoma patients undergoing anti-GD2 immunotherapy: A single arm meta-analysis and systemic review

Letter to the Editor Regarding “Simultaneous Single-Trajectory Endoscopic Biopsy and Third Ventriculostomy in Pineal Region Tumors: A Systematic Review and Single Arm Meta-Analysis”

Letter to the Editor Regarding “Simultaneous Single-Trajectory Endoscopic Biopsy and Third Ventriculostomy in Pineal Region Tumors: A Systematic Review and Single Arm Meta-Analysis”

53039 The prevalence of androgenetic alopecia with hormone therapy in transgender men: a systematic review and single-arm meta-analysis

53039 The prevalence of androgenetic alopecia with hormone therapy in transgender men: a systematic review and single-arm meta-analysis

Outcomes of Single Anastomosis Sleeve Ileal (SASI) Bypass as an Alternative Procedure in Treating Obesity: An Updated Systematic Review and Meta-Analysis.

The Single Anastomosis Sleeve Ileal (SASI) bypass is a novel bariatric procedure that simplifies Santoro's procedure, balancing functional restriction and neuroendocrine modulation while preserving anatomy. We aim to conduct a single-arm meta-analysis of the SASI bypass to explore its moderate-term efficacy, as this might expand the available choices for surgeons to choose the best bariatric surgery that suits the patient's condition. We conducted a comprehensive search on PubMed, Scopus, EMBASE, and Cochrane to identify studies for the SASI bypass surgery focusing on outcomes such as %EWL, %TWL, remission rate of comorbidities, and complications. The statistical analysis was carried out using RStudio version 4.3.2. Heterogeneity was assessed using the Cochrane Q test and I2 statistics. Our findings illuminate SASI's potency by undertaking a single-arm meta-analysis involving 1873 patients across 26 studies. At 12months, we report a noteworthy % Excess Weight Loss (%EWL) (Mean 84.13; 95% CI 78.41-89.85; I2 = 95%), and % Total Weight Loss (%TWL) (Mean 35.17; 95% CI 32.30-38.04; I2 = 97%), highlighting SASI's efficacy on weight loss. Cumulative meta-analyses supported these findings. More weight loss was observed with a 250cm common limb and a greater than 3cm anastomosis. An 88.28% remission rate in type 2 diabetes mellitus (95% CI 79.74-95.03; I2 = 84%) at 12months was observed. Beyond weight outcomes, SASI impacts comorbidities with a good safety profile. Our study positions the SASI bypass as a good alternative option. However, long-term efficacy is yet to be explored in the future.

Symptomatic and Radiographic Improvement Following Surgery for Posterior Fossa Arachnoid Cysts: Meta-Analysis and Literature Review

ObjectiveArachnoid cysts are benign, intradural collections of cerebrospinal fluid that are often asymptomatic but, in rare instances, will grow and may cause symptoms. When these are in the posterior fossa, the symptomatology greatly ranges, and the indications for surgery are not well defined. The objective of this study is to examine radiographic and symptomatic outcomes following surgery for posterior fossa arachnoid cysts (PFAC). MethodsA literature review was performed utilizing PubMed for all studies involving ≥ 5 patients with PFACs who underwent surgery. A single-arm meta-analysis was performed to assess the postoperative radiographic improvement. Given the heterogeneous variety of presenting symptoms, these were not conducive to meta-analyses but the outcomes are reported in detail. ResultsNine publications with 67 patients met inclusion criteria. Excision/fenestration was the most common operation (n=60). Less common included CP shunts (n=2), concurrent excision/fenestration and ETV (n=4), and one patient who underwent concurrent VP/CP shunts. This literature review revealed improvement of headache in 90% of patients; 88% with cerebellar symptoms; 92% with nausea/emesis; 78% with hearing loss; 60% with tinnitus; and 91% with vision deficits. Meta-analysis of seven studies reporting postoperative radiographic size demonstrated that 75% of people experienced decreased PFAC size (Effect Size: 0.75, 95% CI: 0.50-0.94). ConclusionsAlthough there is a high rate of radiographic improvement for PFAC surgery, there is a wide variety of presenting symptoms with differing postoperative improvement rates. This study reinforces the importance of preoperative counseling regarding symptomatic outcomes for PFAC surgery, with supporting statistical analysis but limited by the sample sizes available.

Sexual side effects of antipsychotic drugs in schizophrenia: Protocol for a systematic review with single-arm, pairwise and network meta-analysis of randomized controlled trials and non-randomized studies

Introduction Sexual dysfunctions are common yet underreported side effects of antipsychotics for schizophrenia, affecting 30-80% of treated individuals. These side effects can severely impact social interactions and treatment adherence for individuals with schizophrenia, but comprehensive comparative evidence assessing the risk profiles of different antipsychotics is lacking. This study aims to address this gap using network meta-analysis that integrates data from both randomized-controlled trials (RCTs) and non-randomized studies (NRS). Protocol This systematic review will include both RCTs and NRS focusing on participants with schizophrenia or schizophrenia-like psychoses, without restrictions on symptoms, gender, ethnicity, age, or setting. For interventions, all second-generation antipsychotics will be included. The primary outcome will be the occurrence of at least one sexual adverse event of any kind. Secondary outcomes will be the occurrence of any sexual adverse event evaluated in men and women separately, and any adverse event related to the three phases of sexual response cycle separately: desire (e.g. libido, sexual thoughts), arousal (e.g. erection, lubrication) and orgasm (e.g. ejaculation, anorgasmia), and any adverse effect related to breast dysfunction and menstruation irregularities. Study selection and data extraction will be performed independently by two reviewers. The Cochrane Risk of Bias tool 1 and ROBINS-I will be employed to evaluate the risk of bias for RCTs and NRS, respectively. Single-arm meta-analysis of proportions will synthesize the average frequency of sexual adverse events in treated participants. Pairwise and network meta-analysis of RCTs and NRS will be used to evaluate comparative tolerability. Subgroup and sensitivity analyses will explore possible heterogeneity in results and validate the findings’ robustness. The quality of the evidence will be evaluated using GRADE. Discussion This study will provide vital insights into the sexual side effects of antipsychotics by combining evidence from clinical trials and real-world practice, facilitating better decision-making in choosing the optimal antipsychotic for individuals.

Efficacy of PD-1 or PD-L1 inhibitors for the therapy of cervical cancer with varying PD-L1 expression levels: a single-arm meta-analysis.

To assess the effectiveness and tolerability of both PD-1 and PD-L1 inhibitors in advanced cervical cancer (CC), focusing on varying PD-L1 levels. A comprehensive exploration was carried out on EMBASE, PubMed, Cochrane Library databases as well as Web of Science up to May 25, 2024, for studies involving advanced CC patients receiving PD-1/PD-L1 inhibitors. Inclusion criteria were studies reporting objective response rate (ORR), disease control rate (DCR), median progression-free survival (PFS), as well as median overall survival (OS). Data extraction and quality assessment were performed by two reviewers using the JBI Case Series Critical Appraisal Checklist, followed by a meta-analysis via STATA/MP 16.0. Five eligible studies comprising 223 patients were chosen. ORR and DCR were 42% (95% CI: 17%-66%, P = 0.00) and 70% (95% CI: 22%-117%, P = 0.00), respectively, in the PD-L1 positive patients and were 36% (95% CI: 17%-54%, P = 0.00) and 47% (95% CI: 30%-63%, P = 0.00), respectively, in patients with PD-L1 negativity. For patients exhibiting PD-L1 positivity, median PFS and median OS were 3.98 months (95% CI: 0.80-7.16, P = 0.01) and 11.26 months (95% CI: 3.01-12.58, P = 0.00), respectively. With PD-1/PD-L1 inhibitors, PD-L1 positive CC patients demonstrate superior ORR, DCR, median PFS, and median OS, underscoring PD-L1 as one biomarker for immunotherapy response.