Background Although regulatory changes towards correcting the underrepresentation of women in randomized controlled trials (RCTs) occurred (National Institutes of Health 1994), concerns exist about whether an improvement is taking place. In this systematic review and meta-analysis, we aimed to assess the inclusion rates of women in recent RCTs and to explore the potential barriers for the enrollment of women. Methods RCTs published in 2017 examining any type of intervention in adults were searched in PubMed and Cochrane Library. The following predefined medical fields were included: cardiovascular diseases, neoplasms, endocrine system diseases, respiratory tract diseases, bacterial and fungal infections, viral diseases, digestive system diseases, and immune system diseases. Studies were screened independently by two reviewers, and an equal number of studies was randomly selected per calendric month. The primary outcome was the enrollment rate of women, calculated as the number of randomized women patients divided by the total number of randomized patients. Rates were weighted by their inverse variance; statistical significance was tested using general linear models (GLM). Results Out of 398 RCTs assessed for eligibility, 300 RCTs were included. The enrollment rate of women in all the examined fields was lower than 50%, except for immune system diseases [median enrollment rate of 68% (IQR 46 to 81)]. The overall median enrollment rate of women was 41% (IQR 27 to 54). The median enrollment rate of women decreased with older age of the trials’ participants [mean age of trials’ participants ≤ 45 years: 47% (IQR 30–64), 46–55 years: 46% (IQR 33–58), 56–62 years: 38% (IQR 27–50), ≥ 63 years: 33% (IQR 20–46), p < 0.001]. Methodological quality characteristics showed no significant association with the enrollment rates of women. Out of the 300 included RCTs, eleven did not report on the number of included women. There was no significant difference between these studies and the studies included in the analysis. Conclusions Women are being inadequately represented, in the selected medical fields analyzed in our study, in recent RCTs. Older age is a potential barrier for the enrollment of women in clinical trials. Low inclusion rates of elderly women might create a lack of crucial knowledge in the adverse effects and the benefit/risk profile of any given treatment. Factors that might hinder the participation of women should be sought and addressed in the design of the study.
PurposeInvasive lobular breast cancer (ILC) may be hard to detect using conventional imaging modalities and usually shows less avidity to 18F-FDG PET/CT. 68Ga–fibroblast activation protein inhibitor (FAPI) PET/CT has shown promising results in detecting non–18F-FDG–avid cancers. We aimed to assess the feasibility of detecting metastatic disease in patients with non–18F-FDG–avid ILC.MethodsThis prospective study included patients with metastatic ILC, infiltrative to soft tissues, which was not 18F-FDG avid. The patients underwent 68Ga-FAPI PET/CT for evaluation, which was correlated with the fully diagnostic CT performed at the same time.ResultsSeven women (aged 57 ± 10 years) were included. Among the 30 organs and structures found to be involved by tumor, the number of findings observed by FAPI PET/CT was significantly higher than that observed by CT alone (P = 0.022), especially in infiltrative soft tissue and serosal locations.ConclusionsThis small pilot trial suggests a role for 68Ga-FAPI PET/CT in ILC, which needs to be confirmed by subsequent trials.
BackgroundCoronavirus disease (COVID-19) has caused a pandemic threatening millions of people worldwide. Yet studies specifically assessing the geriatric population are scarce. We aimed to examine the participation of elderly patients in therapeutic or prophylactic trials on COVID-19.MethodsIn this review, randomized controlled trials (RCTs; n=12) comparing therapeutic or prophylactic interventions registered on preprint repositories and/or published since December 2019 were analyzed. We searched in PubMed, leading journals websites, and preprint repositories for RCTs and large observational studies. We aimed to describe the age of included patients, the presence of an upper age limit and of adjusted analyses on age, any exclusion criteria that could limit participation of elderly adults such as comorbidities, cognitive impairment, limitation of life expectancy; and the assessment of long-term outcomes such as the need of rehabilitation or institutionalization. Mean participant ages were reported and compared with observational studies.ResultsTwelve RCTs assessing drug therapy for COVID-19 were included. Mean age of patients included in RCTs was 56.3 years. An upper age limit was applied in three published trials (25%) and in 200/650 (31%) trials registered at clinicaltrials.gov. One trial reported a subgroup analysis in patients ≥65. Patients were excluded for liver-function abnormalities in eight trials, renal disease in six, cardiac disease or risk of torsade de pointes in five, and four for cognitive or mental criteria, which are frequent comorbidities in the oldest patients. Only three trials allowed a family member to provide consent. Patients enrolled in RCTs were on average 20 years younger than those included in large (n≥1000) observational studies. Seven studies had as their primary outcome a clinical endpoint, but none reported cognitive, functional or quality of life outcomes or need for rehabilitation or long-term care facility placement.ConclusionsElderly patients are clearly underrepresented in RCTs, although they comprise the population hardest hit by the COVID-19 pandemic. Long-term outcomes such as the need of rehabilitation or institutionalization were not reported. Future investigations should target specifically this vulnerable population.
Background Coronavirus disease (COVID-19) has caused a pandemic threatening millions of people worldwide. Yet studies specifically assessing the geriatric population are scarce. We aimed to examine the participation of elderly patients in therapeutic or prophylactic trials on COVID-19.Methods In this review, randomized controlled trials (RCTs; n=12) comparing therapeutic or prophylactic interventions registered on preprint repositories and/or published since December 2019 were analyzed. We searched in PubMed, leading journals websites, and preprint repositories for RCTs and large observational studies. We aimed to describe the age of included patients, the presence of an upper age limit and of adjusted analyses on age, any exclusion criteria that could limit participation of elderly adults such as comorbidities, cognitive impairment, limitation of life expectancy; and the assessment of long-term outcomes such as the need of rehabilitation or institutionalization. Mean participant ages were reported and compared with observational studies. Results Twelve RCTs assessing drug therapy for COVID-19 were included. Mean age of patients included in RCTs was 56.3 years. An upper age limit was applied in three published trials (25%) and in 200/650 (31%) trials registered at clinicaltrials.gov. One trial reported a subgroup analysis in patients ≥65. Patients were excluded for liver-function abnormalities in eight trials, renal disease in six, cardiac disease or risk of torsade de pointes in five, and four for cognitive or mental criteria, which are frequent comorbidities in the oldest patients. Only three trials allowed a family member to provide consent. Patients enrolled in RCTs were on average 20 years younger than those included in large (n≥1000) observational studies. Seven studies had as their primary outcome a clinical endpoint, but none reported cognitive, functional or quality of life outcomes or need for rehabilitation or long-term care facility placement.Conclusions Elderly patients are clearly underrepresented in RCTs, although they comprise the population hardest hit by the COVID-19 pandemic. Long-term outcomes such as the need of rehabilitation or institutionalization were not reported. Future investigations should target specifically this vulnerable population.
BackgroundCoronavirus disease (COVID-19) has caused a pandemic threatening millions of people worldwide. Yet studies specifically assessing the geriatric population are scarce. We aimed to examine the participation of elderly patients in therapeutic or prophylactic trials on COVID-19.MethodsIn this review, randomized controlled trials (RCTs; n=12) comparing therapeutic or prophylactic interventions registered on preprint repositories and/or published since December 2019 were analyzed. We searched in PubMed, leading journals websites, and preprint repositories for RCTs and large observational studies. We aimed to describe the age of included patients, the presence of an upper age limit and of adjusted analyses on age, any exclusion criteria that could limit participation of elderly adults such as comorbidities, cognitive impairment, limitation of life expectancy; and the assessment of long-term outcomes such as the need of rehabilitation or institutionalization. Mean participant ages were reported and compared with observational studies.ResultsTwelve RCTs assessing drug therapy for COVID-19 were included. Mean age of patients included in RCTs was 56.3 years. An upper age limit was applied in three published trials (25%) and in 200/650 (31%) trials registered at clinicaltrials.gov. One trial reported a subgroup analysis in patients ≥65. Patients were excluded for liver-function abnormalities in eight trials, renal disease in six, cardiac disease or risk of torsade de pointes in five, and four for cognitive or mental criteria, which are frequent comorbidities in the oldest patients. Only three trials allowed a family member to provide consent. Patients enrolled in RCTs were on average 20 years younger than those included in large (n≥1000) observational studies. Seven studies had as their primary outcome a clinical endpoint, but none reported cognitive, functional or quality of life outcomes or need for rehabilitation or long-term care facility placement.ConclusionsElderly patients are clearly underrepresented in RCTs, although they comprise the population hardest hit by the COVID-19 pandemic. Long-term outcomes such as the need of rehabilitation or institutionalization were not reported. Future investigations should target specifically this vulnerable population.
Objectives: To assess the effect of a commercial Artificial Intelligence (AI) solution implementation in the emergency department on clinical outcomes in a single Level 1 Trauma Center. Methods: A retrospective cohort study for two time periods – Pre-AI (1.1.2017-1.1.2018) and Post-AI (1.1.2019-1.1.2020), in a Level 1 Trauma Center was performed. Participants older than 18 years with a confirmed diagnosis of ICH on head CT upon admission to the emergency department were collected. Study variables included demographics, patient outcomes, and imaging data. Participants admitted to the emergency department during the same time periods for other acute diagnoses (ischemic stroke –IS; and myocardial infarction - MI) served as control groups. Primary outcomes were 30- and 120-day all-cause mortality. Secondary outcome was morbidity based on Modified Rankin Scale for Neurologic Disability (mRS) at discharge. Results: 587 participants (289 Pre-AI – age 71 ± 1, 169 men; 298 Post-AI – age 69 ± 1, 187 men) with ICH were eligible for the analyzed period. Demographics, comorbidities, Emergency Severity Score, type of ICH and length of stay were not significantly different between the two time periods. The 30- and 120-day all-cause mortality weresignificantly reduced in the Post-AI group when compared to the Pre-AI group (27.7% vs 17.5%; p=0.004 and 31.8% vs 21.7%; p=0.017 respectively).Modified Rankin Scale (mRS) at discharge was significantly reduced Post-AI implementation (3.2 vs 2.8; p=0.044). Conclusion:Implementation of an AI based computer aided triage and prioritization solution for flagging participants with ICH in an emergent care setting coincided with significant reductions of 30- and 120-day all-cause mortality and morbidity.
A 22-year-old healthy man presented to the emergency department with worsening left flank and testicular pain. lower abdominal pain and lower urinary tract symptoms, were also noted. Contrast-enhanced CT demonstrated several vascular malformations: both common iliac veins converging to an infra renal inferior vena cava (IVC) with an absent cephalad IVC. Multiple collateral veins were noted, and both the Azygos and Hemiazygos veins were seen dilated, serving as an alternative venous drainage path due to the interrupted IVC. The patient’s CT was also notable for several pathologies: bilateral iliac vein thrombosis and left-sided testicular vein thrombus with surrounding fat stranding, suggestive of testicular vein thrombophlebitis. The patient was admitted, and received antibiotic and anticoagulation treatment, with clinical improvement. Hypercoagulability workup was obtained, and the patient was found to be heterozygous for Factor V Leiden. Interrupted IVC with azygos continuation is an uncommon, and mostly a benign vascular malformation, resulting from abnormal development of IVC-contributing segments during embryogenesis. It is associated with lower limb deep vein thombosis and hyper-coagulable states. It is imperative for radiologists to be acquainted with this entity, in order to avoid misdiagnosis. Testicular vein thrombosis is uncommon, mostly associated with prothrombotic disorders, and it should be considered when coagulopathy is suspected.
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