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Menopause (New York, N.Y.) Aug 2023Ospemifene is a novel selective estrogen receptor modulator developed for the treatment of moderate to severe postmenopausal vulvovaginal atrophy (VVA). (Meta-Analysis)
Meta-Analysis
Efficacy, tolerability, and endometrial safety of ospemifene compared with current therapies for the treatment of vulvovaginal atrophy: a systematic literature review and network meta-analysis.
IMPORTANCE
Ospemifene is a novel selective estrogen receptor modulator developed for the treatment of moderate to severe postmenopausal vulvovaginal atrophy (VVA).
OBJECTIVE
The aim of the study is to perform a systematic literature review (SLR) and network meta-analysis (NMA) to assess the efficacy and safety of ospemifene compared with other therapies used in the treatment of VVA in North America and Europe.
EVIDENCE REVIEW
Electronic database searches were conducted in November 2021 in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Randomized or nonrandomized controlled trials targeting postmenopausal women with moderate to severe dyspareunia and/or vaginal dryness and involving ospemifene or at least one VVA local treatment were considered. Efficacy data included changes from baseline in superficial and parabasal cells, vaginal pH, and the most bothersome symptom of vaginal dryness or dyspareunia, as required for regulatory approval. Endometrial outcomes were endometrial thickness and histologic classifications, including endometrial polyp, hyperplasia, and cancer. For efficacy and safety outcomes, a Bayesian NMA was performed. Endometrial outcomes were compared in descriptive analyses.
FINDINGS
A total of 44 controlled trials met the eligibility criteria ( N = 12,637 participants). Network meta-analysis results showed that ospemifene was not statistically different from other active therapies in most efficacy and safety results. For all treatments, including ospemifene, the posttreatment endometrial thickness values (up to 52 wk of treatment) were under the recognized clinical threshold value of 4 mm for significant risk of endometrial pathology. Specifically, for women treated with ospemifene, endometrial thickness ranged between 2.1 and 2.3 mm at baseline and 2.5 and 3.2 mm after treatment. No cases of endometrial carcinoma or hyperplasia were observed in ospemifene trials, nor polyps with atypical hyperplasia or cancer after up to 52 weeks of treatment.
CONCLUSIONS AND RELEVANCE
Ospemifene is an efficacious, well-tolerated, and safe therapeutic option for postmenopausal women with moderate to severe symptoms of VVA. Efficacy and safety outcomes with ospemifene are similar to other VVA therapies in North America and Europe.
Topics: Female; Humans; Dyspareunia; Vagina; Hyperplasia; Bayes Theorem; Network Meta-Analysis; Vulva; Atrophy; Tamoxifen; Selective Estrogen Receptor Modulators; Vaginal Diseases; Endometrial Neoplasms
PubMed: 37369079
DOI: 10.1097/GME.0000000000002211 -
Human Fertility (Cambridge, England) Dec 2023The purpose of this systematic review is to identify common hysteroscopic findings suggestive of endometritis, chronic or subclinical, based on current scientific... (Review)
Review
The purpose of this systematic review is to identify common hysteroscopic findings suggestive of endometritis, chronic or subclinical, based on current scientific evidence. Data sources were MEDLINE, Embase, PubMed and other sources of grey literature. Four (4) authors independently selected studies addressing hysteroscopic detection of CE based on specific and clearly stated hysteroscopic criteria. The diagnosis was confirmed by histologic assessment, as stated in the materials and methods of these studies included. The initial search identified 599 studies, of which 21 met the inclusion criteria. Significant heterogeneity among published studies on Chronic endometritis (CE) remains the main limitation in performing a metanalysis and further analysis of diagnostic accuracy on the subject. Hysteroscopy is an important diagnostic tool in cases of chronic endometritis when accompanied by endometrial biopsies. Clinicians relate hyperaemia and endometrial oedema with chronic endometritis while more than half include micropolyposis as a pathognomonic feature of this subclinical condition. Micropolyps, stromal oedema, haemorrhagic spots, strawberry aspect, and hyperaemia are proposed as adequate indicators of hysteroscopic evidence of CE according to the literature. The impact of CE in long-term reproductive outcomes remain unclear, thus clinicians ought to communicate this to the patients and provide treatment where clinically appropriate. In addition, we present hysteroscopic images of histologically confirmed CE cases that could play the role of a hysteroscopic atlas.
Topics: Female; Humans; Chronic Disease; Edema; Endometritis; Endometrium; Hyperemia; Hysteroscopy
PubMed: 37811835
DOI: 10.1080/14647273.2023.2265155 -
JAMA Network Open Mar 2024Multiple strategies integrating magnetic resonance imaging (MRI) and clinical data have been proposed to determine the need for a prostate biopsy in men with suspected... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Multiple strategies integrating magnetic resonance imaging (MRI) and clinical data have been proposed to determine the need for a prostate biopsy in men with suspected clinically significant prostate cancer (csPCa) (Gleason score ≥3 + 4). However, inconsistencies across different strategies create challenges for drawing a definitive conclusion.
OBJECTIVE
To determine the optimal prostate biopsy decision-making strategy for avoiding unnecessary biopsies and minimizing the risk of missing csPCa by combining MRI Prostate Imaging Reporting & Data System (PI-RADS) and clinical data.
DATA SOURCES
PubMed, Ovid MEDLINE, Embase, Web of Science, and Cochrane Library from inception to July 1, 2022.
STUDY SELECTION
English-language studies that evaluated men with suspected but not confirmed csPCa who underwent MRI PI-RADS followed by prostate biopsy were included. Each study had proposed a biopsy plan by combining PI-RADS and clinical data.
DATA EXTRACTION AND SYNTHESIS
Studies were independently assessed for eligibility for inclusion. Quality of studies was appraised using the Quality Assessment of Diagnostic Accuracy Studies 2 tool and the Newcastle-Ottawa Scale. Mixed-effects meta-analyses and meta-regression models with multimodel inference were performed. Reporting of this study followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guideline.
MAIN OUTCOMES AND MEASURES
Independent risk factors of csPCa were determined by performing meta-regression between the rate of csPCa and PI-RADS and clinical parameters. Yields of different biopsy strategies were assessed by performing diagnostic meta-analysis.
RESULTS
The analyses included 72 studies comprising 36 366 patients. Univariable meta-regression showed that PI-RADS 4 (β-coefficient [SE], 7.82 [3.85]; P = .045) and PI-RADS 5 (β-coefficient [SE], 23.18 [4.46]; P < .001) lesions, but not PI-RADS 3 lesions (β-coefficient [SE], -4.08 [3.06]; P = .19), were significantly associated with a higher risk of csPCa. When considered jointly in a multivariable model, prostate-specific antigen density (PSAD) was the only clinical variable significantly associated with csPCa (β-coefficient [SE], 15.50 [5.14]; P < .001) besides PI-RADS 5 (β-coefficient [SE], 9.19 [3.33]; P < .001). Avoiding biopsy in patients with lesions with PI-RADS category of 3 or less and PSAD less than 0.10 (vs <0.15) ng/mL2 resulted in reducing 30% (vs 48%) of unnecessary biopsies (compared with performing biopsy in all suspected patients), with an estimated sensitivity of 97% (vs 95%) and number needed to harm of 17 (vs 15).
CONCLUSIONS AND RELEVANCE
These findings suggest that in patients with suspected csPCa, patient-tailored prostate biopsy decisions based on PI-RADS and PSAD could prevent unnecessary procedures while maintaining high sensitivity.
Topics: Male; Humans; Magnetic Resonance Imaging; Prostatic Neoplasms; Prostate-Specific Antigen; Prostate; Biopsy
PubMed: 38551559
DOI: 10.1001/jamanetworkopen.2024.4258 -
Head & Neck Nov 2023The possibility of detecting circulating tumor HPV DNA (ctHPVDNA) in plasma in patients with oropharyngeal cancer has been demonstrated in several reports. However,... (Meta-Analysis)
Meta-Analysis Review
The possibility of detecting circulating tumor HPV DNA (ctHPVDNA) in plasma in patients with oropharyngeal cancer has been demonstrated in several reports. However, these data are from small cohorts and available tests for detection of ctHPVDNA are not fully validated. The aim is to evaluate sensitivity, specificity, and accuracy of ctHPVDNA by ddPCR to define its efficacy in the clinical setting for the diagnosis of HPV + OPSCC. A comprehensive search of three different databases: MEDLINE, Embase, and Cochrane Library databases. A total of 998 patients were evaluated from the 13 studies. OPSSC p16+ were 729, while controls p16- were 269. The meta-analytic study estimated the diagnostic performance of ctHPVDNA as follows: pooled sensitivity and specificity of 0.90 (95% CI: 0.82-0.94) and 0.94 (95% CI: 0.85-0.98), respectively; positive and negative likelihood ratios of 12.6 (95% CI: 4.9-32.1) and 0.05 (95% CI: 0.02-0.13), respectively. ddPCR for ctHPVDNA has good accuracy, sensitivity, and specificity for diagnosis of HPV + OPSCC. ctHPVDNA kinetic represents a great reliable opportunity to improve diagnostic and therapeutic management of cancer patients and could open new perspectives for understanding tumor biology.
Topics: Humans; Papillomavirus Infections; Circulating Tumor DNA; Papillomaviridae; Oropharyngeal Neoplasms; Human Papillomavirus Viruses; DNA, Viral; Head and Neck Neoplasms
PubMed: 37715656
DOI: 10.1002/hed.27515 -
Medical Mycology Jul 2023The (1→3)-β-D-glucan (BDG) is a component of the fungal cell wall that can be detected in serum and used as an adjunctive tool for the diagnosis of invasive mold... (Meta-Analysis)
Meta-Analysis
The (1→3)-β-D-glucan (BDG) is a component of the fungal cell wall that can be detected in serum and used as an adjunctive tool for the diagnosis of invasive mold infections (IMI) in patients with hematologic cancer or other immunosuppressive conditions. However, its use is limited by modest sensitivity/specificity, inability to differentiate between fungal pathogens, and lack of detection of mucormycosis. Data about BDG performance for other relevant IMI, such as invasive fusariosis (IF) and invasive scedosporiosis/lomentosporiosis (IS) are scarce. The objective of this study was to assess the sensitivity of BDG for the diagnosis of IF and IS through systematic literature review and meta-analysis. Immunosuppressed patients diagnosed with proven or probable IF and IS, with interpretable BDG data were eligible. A total of 73 IF and 27 IS cases were included. The sensitivity of BDG for IF and IS diagnosis was 76.7% and 81.5%, respectively. In comparison, the sensitivity of serum galactomannan for IF was 27%. Importantly, BDG positivity preceded the diagnosis by conventional methods (culture or histopathology) in 73% and 94% of IF and IS cases, respectively. Specificity was not assessed because of lacking data. In conclusion, BDG testing may be useful in patients with suspected IF or IS. Combining BDG and galactomannan testing may also help differentiating between the different types of IMI.
Topics: Animals; Fusariosis; beta-Glucans; Invasive Fungal Infections; Sensitivity and Specificity
PubMed: 37381179
DOI: 10.1093/mmy/myad061 -
Oral Diseases Nov 2023To identify the prevalence of geographic tongue in patients >18 years. A systematic literature review was performed in search of population-based observational... (Meta-Analysis)
Meta-Analysis Review
To identify the prevalence of geographic tongue in patients >18 years. A systematic literature review was performed in search of population-based observational studies. Searches were performed using five main databases: Embase, LILACS, PubMed, Scopus and Web of Science; and three gray literature sources: Google Scholar, ProQuest, and OpenGrey. In addition, a manual search in the reference list and consultation with experts on the topic studied were performed. Methodological quality was assessed using the Joanna Briggs Institute's checklist for prevalence studies. Ratio meta-analyses were performed using JAMOVI. Initially, 3046 studies were identified. After a two-phase selection, 11 studies were included for quantitative synthesis. Two studies were classified as of low methodological quality, five studies as of moderate quality, and four as of high quality. Two types of prevalence were analyzed: by period and point. Three studies were included in the period prevalence meta-analysis, and the prevalence was 3% (Confidence interval [CI]: 0.4%-5.5%, n = 9813). Eight studies were included in the point-prevalence meta-analysis, and the prevalence was 3% (CI: -0.2% to 5.5%, n = 10,967). Although there are phases of exacerbation and remission in geographic tongue, prevalence and period prevalence were similar. Approximately one in 30 adults has a geographic tongue.
Topics: Humans; Adult; Prevalence; Glossitis, Benign Migratory; Cross-Sectional Studies
PubMed: 36208129
DOI: 10.1111/odi.14397 -
Journal of Clinical Neuroscience :... Jan 2024Considering the different results regarding the correlation between Magnetic Resonance Imaging (MRI) structural measures and cognitive dysfunction in patients with MS,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Considering the different results regarding the correlation between Magnetic Resonance Imaging (MRI) structural measures and cognitive dysfunction in patients with MS, we aimed to perform a systematic review and meta-analysis study to investigate the correlation between T1 and T2 weighted lesions and cognitive scores to find the most robust MRI markers for cognitive function in MS population.
METHODS
The literature of this paper was identified through a comprehensive search of electronic datasets including PubMed, Scopus, Web of Science, and Embase in February 2022. Studies that reported the correlation between cognitive status and T1 and T2 weighted lesions in MS patients were selected.
RESULTS
21 studies with a total of 3771 MS patients with mean ages ranging from 30 to 57 years were entered into our study. Our analysis revealed that the volume of T1 lesions was significantly correlated with Symbol Digit Modality test (SDMT) (r: -0.30, 95 %CI: -0.59, -0.01) and Paced Auditory Serial-Addition Task (PASAT) scores (r: -0.23, 95 %CI: -0.36, -0.10). We investigated the correlation between T2 lesions and cognitive scores. The pooled estimates of z scores were significant for SDMT (r: -0.27, 95 %CI: -0.51, -0.03) and PASAT (r: -0.27, 95 %CI: -0.41, -0.13).
CONCLUSION
In conclusion, our systematic review and meta-analysis study provides strong evidence of the correlation between T1 and T2 lesions and cognitive function in MS patients. Further research is needed to explore the potential mechanisms underlying this relationship and to develop targeted interventions to improve cognitive outcomes in MS patients.
Topics: Humans; Adult; Middle Aged; Multiple Sclerosis; Cognition; Cognitive Dysfunction; Magnetic Resonance Imaging; Neuropsychological Tests
PubMed: 37952373
DOI: 10.1016/j.jocn.2023.11.014 -
Journal of Magnetic Resonance Imaging :... Dec 2023Hepatocellular carcinoma (HCC) can be diagnosed without pathologic confirmation in high-risk patients. Therefore, it is necessary to compare current imaging criteria for... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Hepatocellular carcinoma (HCC) can be diagnosed without pathologic confirmation in high-risk patients. Therefore, it is necessary to compare current imaging criteria for noninvasive-diagnosis of HCC.
PURPOSE
To systematically compare performance of 2018 European Association for the Study of the Liver (EASL) criteria and Liver Imaging Reporting and Data System (LI-RADS) for noninvasive-diagnosis of HCC.
STUDY TYPE
Systematic review and meta-analysis.
SUBJECTS
Eight studies with 2232 observations, including 1617 HCCs.
FIELD STRENGTH/SEQUENCE
1.5 T, 3.0 T/T2-weighted, unenhanced T1-weighted in-/opposed-phases, multiphase T1-weighted imaging.
ASSESSMENT
Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, two reviewers independently reviewed and extracted data, including patient characteristics, index test, reference standard and outcomes, from studies intraindividually comparing the sensitivities and specificities of 2018 EASL-criteria and LR-5 of LI-RADS for HCC. Risk of bias and concerns regarding applicability were evaluated using QUADAS-2 tool. Subgroup analysis was performed based on observation size (≥20 mm, 10-19 mm).
STATISTICAL TESTS
Bivariate random-effects model to calculate pooled per-observation sensitivity and specificity of both imaging criteria, and pooled estimates of intraindividual paired data were compared considering the correlation. Forest and linked-receiver-operating-characteristic plots were drawn, and study heterogeneity was assessed using Q-test and Higgins-index. Publication bias was evaluated by Egger's test. A P-value <0.05 was considered statistically significant, except for heterogeneity (P < 0.10).
RESULTS
The sensitivity for HCC did not differ significantly between the imaging-based diagnosis using EASL-criteria (61%; 95% CI, 50%-73%) and LR-5 (64%; 95% CI, 53%-76%; P = 0.165). The specificities were also not significantly different between EASL-criteria (92%; 95% CI, 89%-94%) and LR-5 (94%; 95% CI, 91%-96%; P = 0.257). In subgroup analysis, no statistically significant differences were identified in the pooled performances between the two criteria for observations ≥20 mm (sensitivity P = 0.065; specificity P = 0.343) or 10-19 mm (sensitivity P > 0.999; specificity P = 0.851). There was no publication bias for EASL (P = 0.396) and LI-RADS (P = 0.526).
DATA CONCLUSION
In the present meta-analysis of paired comparisons, the pooled sensitivities and specificities were not significantly different between 2018 EASL-criteria and LR-5 of LI-RADS for noninvasive-diagnosis of HCC.
EVIDENCE LEVEL
3.
TECHNICAL EFFICACY
Stage 2.
Topics: Humans; Carcinoma, Hepatocellular; Liver Neoplasms; Magnetic Resonance Imaging; Sensitivity and Specificity; Retrospective Studies; Tomography, X-Ray Computed; Contrast Media
PubMed: 37010244
DOI: 10.1002/jmri.28716 -
Journal of Clinical Neuroscience :... Sep 2023Overall survival (OS)for glioblastoma multiforme (GBM) has a known association with the extent of tumor resection with gross total resection (GTR) typically considered... (Meta-Analysis)
Meta-Analysis Review
Overall survival (OS)for glioblastoma multiforme (GBM) has a known association with the extent of tumor resection with gross total resection (GTR) typically considered as the upper limit. In certain regions such as the anterior temporal lobe, more extensive resection by means of a lobectomy may be feasible. In our systematic review and meta-analysis, we aimed to compare the outcomes of lobectomy and GTR for GBM. PubMed and Embase were queriedfor studies that compared the outcomes after lobectomy or GTR for GBM. The primary outcomes were OS, progression-free survival (PFS), and Karnofksy Performance Status (KPS) score at the latest follow-up. The secondary outcomes were seizure control at the latest follow-up and complication rates. Meta-analysis for OS and PFS was performed using individual-participant data reconstructed from published Kaplan-Meier curves. Random-effect meta-analysis was performed for KPS. The secondary outcomes were pooled using descriptive statistics. Of the 795 records screened, 6 were included in our study. Meta-analysis revealed that anterior temporal, frontal, or occipital lobectomy was associated with significantly better OS (p < 0.001) and PFS (p < 0.001) than GTR, but not KPS (MD = 6.37; 95% CI=(-13.80, 26.54); p = 0.536). Anterior temporal lobectomy was associated with significantly better seizure control rates than GTR for temporal GBM (OR = 27; 95% CI=(1.4, 515.9); p = 0.002). There was no statistically significant difference in complication rates between anterior temporal, frontal, or occipital lobectomy and GTR. In conclusion, lobectomy was associated with significantly better OS, PFS, and seizure control than GTR for GBM.
Topics: Humans; Glioblastoma; Brain Neoplasms; Psychosurgery; Progression-Free Survival; Seizures; Retrospective Studies; Neurosurgical Procedures
PubMed: 37487449
DOI: 10.1016/j.jocn.2023.07.016 -
Journal of Cancer Education : the... Aug 2023Cholangiocarcinoma (CCA), caused mainly by Opisthorchis viverrini (OV) infection, is a public health issue. Health literacy can play a significant role in preventing OV... (Meta-Analysis)
Meta-Analysis Review
Cholangiocarcinoma (CCA), caused mainly by Opisthorchis viverrini (OV) infection, is a public health issue. Health literacy can play a significant role in preventing OV and CCA and adopting preventive behaviors. Therefore, this study aimed to evaluate, summarize, and synthesize the current evidence on health literacy programs for preventing OV and CCA.A systematic literature search, with Thai and English languages, was performed using electronic databases through PubMed, Google Scholar, ThaiJo, ThaiLis, and Embase to identify studies examining health literacy programs to prevent OV and CCA. We followed PRISMA 2020 guidelines. In addition, we used the RevMan software to perform a meta-analysis to analyze effect sizes using a fixed-effects model and measures of heterogeneity using Cochran's Q and I. This meta-analysis included seven studies that met the criteria. The results showed that the people who received a program had an increased health literacy overall and in each aspect with a statistically significant (p < 0.001). So, health literacy programs can assist people in understanding their health and gaining access to health information and services. Additionally, the effect of programs (communication abilities, self-management, media and information literacy, and decision-making in practice) can help prevent OV and CCA. As a result, multi-disciplinary healthcare teams are crucial to developing preventive programs to prevent OV and CCA. Further studies need to be done and applied to these programs to modify behavior to avoid other diseases.
Topics: Animals; Humans; Opisthorchiasis; Opisthorchis; Health Literacy; Cholangiocarcinoma; Bile Duct Neoplasms; Bile Ducts, Intrahepatic
PubMed: 36637714
DOI: 10.1007/s13187-023-02265-0