-
Multiple Sclerosis and Related Disorders Jul 2024Magnetic resonance imaging [MRI] findings in Neuromyelitis optica spectrum disorder [NMOSD] and Multiple Sclerosis [MS] patients could lead us to discriminate toward... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Magnetic resonance imaging [MRI] findings in Neuromyelitis optica spectrum disorder [NMOSD] and Multiple Sclerosis [MS] patients could lead us to discriminate toward them. For instance, U-fiber and Dawson's finger-type lesions are suggestive of MS, however linear ependymal lesions raise the possibility of NMOSD. Recently, artificial intelligence [AI] models have been used to discriminate between NMOSD and MS based on MRI features. In this study, we aim to systematically review the capability of AI algorithms in NMOSD and MS discrimination based on MRI features.
METHOD
We searched PubMed, Scopus, Web of Sciences, Embase, and IEEE databases up to August 2023. All studies that used AI-based algorithms to discriminate between NMOSD and MS using MRI features were included, without any restriction in time, region, race, and age. Data on NMOSD and MS patients, Aquaporin-4 antibodies [AQP4-Ab] status, diagnosis criteria, performance metrics (accuracy, sensitivity, specificity, and AUC), artificial intelligence paradigm, MR imaging, and used features were extracted. This study is registered with PROSPERO, CRD42023465265.
RESULTS
Fifteen studies were included in this systematic review, with sample sizes ranging between 53 and 351. 1,362 MS patients and 1,118 NMOSD patients were included in our systematic review. AQP4-Ab was positive in 94.9% of NMOSD patients in 9 studies. Eight studies used machine learning [ML] as a classifier, while 7 used deep learning [DL]. AI models based on only MRI or MRI and clinical features yielded a pooled accuracy of 82% (95% CI: 78-86%), sensitivity of 83% (95% CI: 79-88%), and specificity of 80% (95% CI: 75-86%). In subgroup analysis, using only MRI features yielded an accuracy, sensitivity, and specificity of 83% (95% CI: 78-88%), 81% (95% CI: 76-87%), and 84% (95% CI: 79-89%), respectively.
CONCLUSION
AI models based on MRI features showed a high potential to discriminate between NMOSD and MS. However, heterogeneity in MR imaging, model evaluation, and reporting performance metrics, among other confounders, affected the reliability of our results. Well-designed studies on multicentric datasets, standardized imaging and evaluation protocols, and detailed transparent reporting of results are needed to reach optimal performance.
Topics: Humans; Neuromyelitis Optica; Magnetic Resonance Imaging; Multiple Sclerosis; Artificial Intelligence; Algorithms; Diagnosis, Differential
PubMed: 38781885
DOI: 10.1016/j.msard.2024.105682 -
Investigational New Drugs Jun 2024In the era of precision oncology (PO), systemic therapies for patients (pts) with solid tumors have shifted from chemotherapy (CT) to targeted therapy (TT) and...
In the era of precision oncology (PO), systemic therapies for patients (pts) with solid tumors have shifted from chemotherapy (CT) to targeted therapy (TT) and immunotherapy (IO). This systematic survey describes features of trials enrolling between 2010 and 2020, focusing on inclusion criteria, type of dose escalation scheme (DES) utilized, and use of expansion cohorts (ECs). A literature search identified phase I studies in adults with solid tumors published January 1, 2000- December 31, 2020 from 12 journals. We included only studies enrolling between 2010 and 2020 to better capture the PO era. Two reviewers abstracted data; a third established concordance. Of 10,744 studies, 10,195 were non-topical or enrolled prior to 2010; 437 studies were included. The most common drug classes were TT (47.6%), IO (22%), and CT (6.9%). In studies which reported race, patients were predominantly white (61.7%) or Asian (25.7%), followed by black (6.5%) or other (6.1%). Heterogeneity was observed in the reporting and specification of study inclusion criteria. Only 40.1% of studies utilized ECs, and among the studies which used ECS, 46.6% were defined by genomic selection. Rule-based DES were used in 89% of trials; a 3+3 design was used in 80.5%. Of all drugs tested, 37.5% advanced to phase II, while 10.3% garnered regulatory licensure (for an indication tested in phase I). In the era of PO, TT and IO have emerged as the most studied agents in phase I trials. Rule-based DES, which are more relevant for escalating CT, are still chiefly utilized.
Topics: Humans; Neoplasms; Precision Medicine; Clinical Trials, Phase I as Topic; Antineoplastic Agents; Molecular Targeted Therapy; Immunotherapy; Medical Oncology
PubMed: 38775890
DOI: 10.1007/s10637-024-01445-z -
Obesity Reviews : An Official Journal... May 2024Beyond obesity, excess levels of visceral adipose tissue (VAT) significantly contribute to the risk of developing metabolic syndrome (MetS), although thresholds for... (Review)
Review
Beyond obesity, excess levels of visceral adipose tissue (VAT) significantly contribute to the risk of developing metabolic syndrome (MetS), although thresholds for increased risk vary based on population, regions of interest, and units of measure employed. We sought to determine whether a common threshold exists that is indicative of heightened MetS risk across all populations, accounting for sex, age, BMI, and race/ethnicity. A systematic literature review was conducted in September 2023, presenting threshold values for elevated MetS risk. Standardization equations harmonized the results from DXA, CT, and MRI systems to facilitate a comparison of threshold variations across studies. A total of 52 papers were identified. No single threshold could accurately indicate elevated risk for both males and females across varying BMI, race/ethnicity, and age groups. Thresholds fluctuated from 70 to 165.9 cm, with reported values consistently lower in females. Generally, premenopausal females and younger adults manifested elevated risks at lower VAT compared to their older counterparts. Notably, Asian populations exhibited elevated risks at lower VAT areas (70-136 cm) compared to Caucasian populations (85.6-165.9 cm). All considered studies reported associations of VAT without accommodating covariates. No single VAT area threshold for elevated MetS risk was discernible post-harmonization by technology, units of measure, and region of interest. This review summarizes available evidence for MetS risk assessment in clinical practice. Further exploration of demographic-specific interactions between VAT area and other risk factors is imperative to comprehensively delineate overarching MetS risk.
PubMed: 38761009
DOI: 10.1111/obr.13767 -
The Journal of Allergy and Clinical... Aug 2024The demographic characteristics of patients with eosinophilic gastrointestinal diseases (EGIDs) are poorly understood. Population-based assessments of EGID demographics...
BACKGROUND
The demographic characteristics of patients with eosinophilic gastrointestinal diseases (EGIDs) are poorly understood. Population-based assessments of EGID demographics may indicate health disparities in diagnosis.
OBJECTIVES
We aimed to characterize the demographic distribution of EGIDs and evaluate the potential for bias in reporting patient characteristics.
METHODS
We conducted a systematic review, extracting data on age, sex, gender, race, ethnicity, body mass index, insurance, and urban/rural residence on EGID patients and the source population. Differences in proportions were assessed by chi-square tests. Demographic reporting was compared to recent guidelines.
RESULTS
Among 50 studies that met inclusion/exclusion criteria, 12 reported ≥1 demographic feature in both EGID and source populations. Except for age and sex or gender, demographics were rarely described (race = 4, ethnicity = 1, insurance = 1) or were not described (body mass index, urban/rural residence). A higher proportion of male subjects was observed for EoE or esophageal eosinophilia relative to the source population, but no difference in gender or sex distribution was observed for other EGIDs. "Sex" and "gender" were used interchangeably, and frequently only the male proportion was reported. Reporting of race and ethnicity was inconsistent with guidelines.
CONCLUSION
Current data support a male predominance for EoE only. Evidence was insufficient to support enrichment of EGIDs in any particular racial, ethnic, or other demographic group. Population-based studies presenting demographics on both cases and source populations are needed. Implementation of guidelines for more inclusive reporting of demographic characteristics is crucial to prevent disparities in timely diagnosis and management of patients with EGIDs.
PubMed: 38745866
DOI: 10.1016/j.jacig.2024.100260 -
Osteoporosis International : a Journal... May 2024This systematic review seeks to evaluate the proportion of fragility fracture patients screened in secondary fracture prevention programs who were indicated for... (Review)
Review
PURPOSE
This systematic review seeks to evaluate the proportion of fragility fracture patients screened in secondary fracture prevention programs who were indicated for pharmacological treatment, received prescriptions for bone-active medications, and initiated the prescribed medication. Additionally, the study aims to analyze equity in pharmacological treatment by examining equity-related variables including age, sex, gender, race, education, income, and geographic location.
METHODS
We conducted a systematic review to ascertain the proportion of fragility fracture patients indicated for treatment who received prescriptions and/or initiated bone-active medication through secondary fracture prevention programs. We also examined treatment indications reported in studies and eligibility criteria to confirm patients who were eligible for treatment. To compute the pooled proportions for medication prescription and initiation, we carried out a single group proportional meta-analysis. We also extracted the proportions of patients who received a prescription and/or began treatment based on age, sex, race, education, socioeconomic status, location, and chronic conditions.
RESULTS
This review included 122 studies covering 114 programs. The pooled prescription rate was 77%, and the estimated medication initiation rate was 71%. Subgroup analysis revealed no significant difference in treatment initiation between the Fracture Liaison Service and other programs. Across all studies, age, sex, and socioeconomic status were the only equity variables reported in relation to treatment outcomes.
CONCLUSION
Our systematic review emphasizes the need for standardized reporting guidelines in post-fracture interventions. Moreover, considering equity stratifiers in the analysis of health outcomes will help address inequities and improve the overall quality and reach of secondary fracture prevention programs.
PubMed: 38740589
DOI: 10.1007/s00198-024-07078-5 -
Thrombosis Research Jun 2024COVID-19 has disproportionately affected racialized populations, with particular impact among individuals of Black individuals. However, it is unclear whether... (Meta-Analysis)
Meta-Analysis Review
IMPORTANCE
COVID-19 has disproportionately affected racialized populations, with particular impact among individuals of Black individuals. However, it is unclear whether disparities in venous thromboembolic (VTE) complications exist between Black individuals and those belonging to other racial groups with confirmed SARS-CoV2 infections.
OBJECTIVE
To summarize the prevalence and moderators associated with VTE among Black COVID-19 patients in minoritized settings, and to compare this to White and Asian COVID-19 patients according to sex, age, and comorbid health conditions (heart failure, cancer, obesity, hypertension).
DESIGN SETTING, AND PARTICIPANTS
A systematic search of MEDLINE, Embase, CINAHL and CENTRAL for articles or reports published from inception to February 15, 2023.
STUDY SELECTION
Reports on VTE among Black individuals infected with SARS-CoV2, in countries where Black people are considered a minority population group.
DATA EXTRACTION AND SYNTHESIS
Study characteristics and results of eligible studies were independently extracted by 2 pairs of reviewers. VTE prevalence was extracted, and risk of bias was assessed. Prevalence estimates of VTE prevalence among Black individuals with COVID19 in each study were pooled. Where studies provided race-stratified VTE prevalence among COVID19 patients, odds ratios were generated using a random-effects model.
MAIN OUTCOMES AND MEASURES
Prevalence of VTE, comprising of deep vein thrombosis and pulmonary embolism.
RESULTS
Ten studies with 66,185 Black individuals reporting the prevalence of COVID-19 associated VTE were included. Weighted median age of included studies was 47.60. Pooled prevalence of COVID-19 associated VTE was 7.2 % (95 % CI, 3.8 % - 11.5 %) among Black individuals. Among individuals with SARS-CoV2 infections, Black population had higher risks of VTE compared to their White (OR = 1.79, [95 % CI 1.28-2.53], p < .001) or Asian (OR = 2.01, [95 % CI, 1.14-3.60], p = .017) counterparts, or patients with other racial identities (OR = 2.01, [95 % CI, 1.39, 2.92]; p < .001).
CONCLUSIONS AND RELEVANCE
Black individuals with COVID-19 had substantially higher risk of VTE compared to White or Asian individuals. Given racial disparities in thrombotic disease burden related to COVID-19, medical education, research, and health policy interventions are direly needed to ensure adequate disease awareness among Black individuals, to facilitate appropriate diagnosis and treatment among Black patients with suspected and confirmed VTE, and to advocate for culturally safe VTE prevention strategies, including pre-existing inequalities to the COVID-19 pandemic that persist after the crisis.
Topics: Humans; COVID-19; Venous Thromboembolism; White People; Prevalence; SARS-CoV-2; Asian People; Female; Male; Risk Factors; Minority Groups; Black People
PubMed: 38733691
DOI: 10.1016/j.thromres.2024.05.007 -
Frontiers in Psychology 2024Ethnic-racial identity (ERI) development refers to how individuals' experiences, beliefs, and attitudes influence understanding of ethnic-racial group membership....
BACKGROUND
Ethnic-racial identity (ERI) development refers to how individuals' experiences, beliefs, and attitudes influence understanding of ethnic-racial group membership. Messages about race, from multiple ecosystems, influence identity development and how individuals come to form their ERI. There has been a shift in ERI research to focus on Multiracial populations, however, most of the research focus is on Black/white biracial and general, non-specified Multiracial populations. The ERI development process and experience for persons of other Multiracial backgrounds (e.g., AfroLatinx or AsianBlack) is not as extensively studied. This systematic literature review aims to elucidate the existing conceptualization of Multiracial ERI development for non-Black/white biracial and general Multiracial populations in the United States.
METHODS
A comprehensive search strategy was employed across multiple academic databases to identify relevant studies based on explicit inclusion criteria. The initial search resulted in 1,846 articles, but when only Black/white biracial and non-specified general Multiracial studies were eliminated from this review, only 18 articles met the criteria for inclusion.
RESULTS
Common themes emerged from the reviewed literature, including the importance of spaces, conflicting social messages directed at Multiracial individuals, and coping responses used by Multiracial individuals when faced with challenges by family members and peers regarding their multiracial identity.
DISCUSSION
The findings underscore the need for a more nuanced exploration of ERI development among diverse Multiracial populations. Understanding the unique strengths, experiences, and challenges of different Multiracial populations beyond the Black-white biracial paradigm is essential for understanding ERI development across and between different Multiracial populations in today's world.
PubMed: 38725948
DOI: 10.3389/fpsyg.2024.1307624 -
The Lancet. Diabetes & Endocrinology Jun 2024Medications for obesity have been studied in various populations over the past three decades. We aimed to quantify the baseline demographic characteristics of BMI, sex,... (Review)
Review
Medications for obesity have been studied in various populations over the past three decades. We aimed to quantify the baseline demographic characteristics of BMI, sex, age, and race in randomised clinical trials (RCTs) across three decades to establish whether the population studied is representative of the global population affected by the disease. Clinical trials of 12 medications for obesity (ie, orlistat, naltrexone-bupropion, topiramate-phentermine, liraglutide, semaglutide, lorcaserin, sibutramine, rimonabant, taranabant, tirzepatide, retatrutide, and orforglipron) published from Jan 20, 1999, to Nov 12, 2023, were assessed through a systematic review for methodological quality and baseline demographic characteristics. 246 RCTs were included, involving 139 566 participants with or without type 2 diabetes. Most trials over-recruited White, female participants aged 40 years or older with class 1 (30·0-34·9 kg/m) and class 2 (35·0-39·9 kg/m) obesity; older participants, those with class 3 (≥40·0 kg/m) obesity, non-White participants, and male participants were under-recruited. Our systematic review suggests that future trials need to recruit traditionally under-represented populations to allow for accurate measures of efficacy of medications for obesity, enabling more informed decisions by clinicians. It is also hoped that these data will help to refine trial recruitment strategies to ensure that future studies are relevant to the population affected by obesity.
Topics: Humans; Obesity; Anti-Obesity Agents; Female; Male; Body Mass Index; Sex Factors; Randomized Controlled Trials as Topic; Racial Groups; Adult
PubMed: 38723646
DOI: 10.1016/S2213-8587(24)00098-6 -
BMJ Open May 2024To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal...
OBJECTIVE
To characterise sex and gender-based analysis (SGBA) and diversity metric reporting, representation of female/women participants in acute care trials and temporal changes in reporting before and after publication of the 2016 Sex and Gender Equity in Research guideline.
DESIGN
Systematic review.
DATA SOURCES
We searched MEDLINE for trials published in five leading medical journals in 2014, 2018 and 2020.
STUDY SELECTION
Trials that enrolled acutely ill adults, compared two or more interventions and reported at least one clinical outcome.
DATA ABSTRACTION AND SYNTHESIS
4 reviewers screened citations and 22 reviewers abstracted data, in duplicate. We compared reporting differences between intensive care unit (ICU) and cardiology trials.
RESULTS
We included 88 trials (75 (85.2%) ICU and 13 (14.8%) cardiology) (n=111 428; 38 140 (34.2%) females/women). Of 23 (26.1%) trials that reported an SGBA, most used a forest plot (22 (95.7%)), were prespecified (21 (91.3%)) and reported a sex-by-intervention interaction with a significance test (19 (82.6%)). Discordant sex and gender terminology were found between headings and subheadings within baseline characteristics tables (17/32 (53.1%)) and between baseline characteristics tables and SGBA (4/23 (17.4%)). Only 25 acute care trials (28.4%) reported race or ethnicity. Participants were predominantly white (78.8%) and male/men (65.8%). No trial reported gendered-social factors. SGBA reporting and female/women representation did not improve temporally. Compared with ICU trials, cardiology trials reported significantly more SGBA (15/75 (20%) vs 8/13 (61.5%) p=0.005).
CONCLUSIONS
Acute care trials in leading medical journals infrequently included SGBA, female/women and non-white trial participants, reported race or ethnicity and never reported gender-related factors. Substantial opportunity exists to improve SGBA and diversity metric reporting and recruitment of female/women participants in acute care trials.
PROSPERO REGISTRATION NUMBER
CRD42022282565.
Topics: Humans; Female; Male; Critical Care; Periodicals as Topic; Sex Factors; Journal Impact Factor; Clinical Trials as Topic; Gender Equity; Cardiology
PubMed: 38719297
DOI: 10.1136/bmjopen-2023-081118 -
The Cochrane Database of Systematic... May 2024Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infections (LRTIs) in infants. Maternal RSV vaccination is a preventive strategy of great... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infections (LRTIs) in infants. Maternal RSV vaccination is a preventive strategy of great interest, as it could have a substantial impact on infant RSV disease burden. In recent years, the clinical development of maternal RSV vaccines has advanced rapidly.
OBJECTIVES
To assess the efficacy and safety of maternal respiratory syncytial virus (RSV) vaccination for preventing RSV disease in infants.
SEARCH METHODS
We searched Cochrane Pregnancy and Childbirth's Trials Register and two other trials registries on 21 October 2022. We updated the search on 27 July 2023, when we searched MEDLINE, Embase, CENTRAL, CINAHL, and two trials registries. Additionally, we searched the reference lists of retrieved studies and conference proceedings. There were no language restrictions on our searches.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) comparing maternal RSV vaccination with placebo or no intervention in pregnant women of any age. The primary outcomes were hospitalisation with clinically confirmed or laboratory-confirmed RSV disease in infants. The secondary outcomes covered adverse pregnancy outcomes (intrauterine growth restriction, stillbirth, and maternal death) and adverse infant outcomes (preterm birth, congenital abnormalities, and infant death).
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods and assessed the certainty of evidence using the GRADE approach.
MAIN RESULTS
We included six RCTs (25 study reports) involving 17,991 pregnant women. The intervention was an RSV pre-F protein vaccine in four studies, and an RSV F protein nanoparticle vaccine in two studies. In all studies, the comparator was a placebo (saline, formulation buffer, or sterile water). We judged four studies at overall low risk of bias and two studies at overall high risk (mainly due to selection bias). All studies were funded by pharmaceutical companies. Maternal RSV vaccination compared with placebo reduces infant hospitalisation with laboratory-confirmed RSV disease (risk ratio (RR) 0.50, 95% confidence interval (CI) 0.31 to 0.82; 4 RCTs, 12,216 infants; high-certainty evidence). Based on an absolute risk with placebo of 22 hospitalisations per 1000 infants, our results represent 11 fewer hospitalisations per 1000 infants from vaccinated pregnant women (15 fewer to 4 fewer). No studies reported infant hospitalisation with clinically confirmed RSV disease. Maternal RSV vaccination compared with placebo has little or no effect on the risk of congenital abnormalities (RR 0.96, 95% CI 0.88 to 1.04; 140 per 1000 with placebo, 5 fewer per 1000 with RSV vaccination (17 fewer to 6 more); 4 RCTs, 12,304 infants; high-certainty evidence). Maternal RSV vaccination likely has little or no effect on the risk of intrauterine growth restriction (RR 1.32, 95% CI 0.75 to 2.33; 3 per 1000 with placebo, 1 more per 1000 with RSV vaccination (1 fewer to 4 more); 4 RCTs, 12,545 pregnant women; moderate-certainty evidence). Maternal RSV vaccination may have little or no effect on the risk of stillbirth (RR 0.81, 95% CI 0.38 to 1.72; 3 per 1000 with placebo, no difference with RSV vaccination (2 fewer to 3 more); 5 RCTs, 12,652 pregnant women). There may be a safety signal warranting further investigation related to preterm birth. This outcome may be more likely with maternal RSV vaccination, although the 95% CI includes no effect, and the evidence is very uncertain (RR 1.16, 95% CI 0.99 to 1.36; 6 RCTs, 17,560 infants; very low-certainty evidence). Based on an absolute risk of 51 preterm births per 1000 infants from pregnant women who received placebo, there may be 8 more per 1000 infants from pregnant women with RSV vaccination (1 fewer to 18 more). There was one maternal death in the RSV vaccination group and none in the placebo group. Our meta-analysis suggests that RSV vaccination compared with placebo may have little or no effect on the risk of maternal death (RR 3.00, 95% CI 0.12 to 73.50; 3 RCTs, 7977 pregnant women; low-certainty evidence). The effect of maternal RSV vaccination on the risk of infant death is very uncertain (RR 0.81, 95% CI 0.36 to 1.81; 6 RCTs, 17,589 infants; very low-certainty evidence).
AUTHORS' CONCLUSIONS
The findings of this review suggest that maternal RSV vaccination reduces laboratory-confirmed RSV hospitalisations in infants. There are no safety concerns about intrauterine growth restriction and congenital abnormalities. We must be careful in drawing conclusions about other safety outcomes owing to the low and very low certainty of the evidence. The evidence available to date suggests RSV vaccination may have little or no effect on stillbirth, maternal death, and infant death (although the evidence for infant death is very uncertain). However, there may be a safety signal warranting further investigation related to preterm birth. This is driven by data from one trial, which is not fully published yet. The evidence base would be much improved by more RCTs with substantial sample sizes and well-designed observational studies with long-term follow-up for assessment of safety outcomes. Future studies should aim to use standard outcome measures, collect data on concomitant vaccines, and stratify data by timing of vaccination, gestational age at birth, race, and geographical setting.
Topics: Humans; Pregnancy; Female; Respiratory Syncytial Virus Infections; Randomized Controlled Trials as Topic; Respiratory Syncytial Virus Vaccines; Infant; Infant, Newborn; Stillbirth; Premature Birth; Pregnancy Complications, Infectious; Hospitalization; Fetal Growth Retardation; Pregnancy Outcome; Vaccination; Congenital Abnormalities; Bias; Infant Death
PubMed: 38695784
DOI: 10.1002/14651858.CD015134.pub2