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A Competency-Based Ultrasound-Guided Breast Biopsy Training Program for Radiologists From Low-and-Middle-Income Countries that Leverages Mobile Health Technology (NCT04501419): A Study Protocol
Full text linkIntroductionWhile ultrasound-guided breast biopsy (UGBB) performed by a radiologist is the standard of care in high-income countries for diagnosing breast cancer, blind or surgical biopsy has been the norm in low-and middle-income countries (LMIC) in part because LMIC radiologists lack the skill to perform UGBB. We present the study protocol of a competency-based UGBB training program for LMIC Nigerian radiologists that leverages mobile health technology.MethodsThis institutional review board-approved prospective multi-institutional single-arm clinical trial (ClinicalTrials.gov identifier: NCT04501419) involves 13 Nigerian radiologists from eight tertiary hospitals in South West and South East Nigeria. Our training program is unique because it uses a competency-based curriculum developed specifically for LMIC radiologists. The competency-based curriculum incorporates blended learning (e-learning and trainer-led), simulation (supervised and unsupervised), and patient biopsy (supervised and unsupervised) components. The study time frame is two years: 1 year for the trainees to complete active training and patient recruitment and another 1 year for patient follow-up. Primary outcome measures include trainees' competency (measured using the Ottawa Surgical Competency Operating Room Evaluation (O-SCORE)), the radiology-pathology concordance rate, and the complication rate. Secondary outcome measures include the diagnostic interval and the positive predictive value of UGBB.ConclusionBuilding capacity for UGBB in Nigeria and other LMIC can potentially improve breast cancer outcomes through early diagnosis. This training program is part of an implementation multi-component strategy package in Nigeria to improve breast cancer outcomes. This training program can also be adapted for other image-guided procedures that could impact global cancer control through diagnosis, therapeutic intervention, and/or palliation.No embarg
Health-related quality of life in racial and ethnic minority adults with type 2 diabetes: validity and responsiveness of the EQ-5D-3L
Full text linkPurpose
Health-related quality of life (HRQL) assessment provides insights into the lived experiences of diverse populations. This study evaluated the convergent validity and responsiveness of the EQ-5D-3L in racial/ethnic minority populations with type 2 diabetes and elevated hemoglobin A1c (HbA1c).
Methods
Secondary data from a clinical trial of a diabetes adherence support intervention for African-American and Latinx patients with type 2 diabetes (NCT02990299) were analyzed. Clinical (HbA1c, systolic blood pressure [SBP], body mass index [BMI]), psychological (brief 4-item diabetes distress scale [DDS4] for diabetes-related distress, 9-item patient health questionnaire [PHQ-9] for depressive symptoms), and HRQL (EQ-5D-3L) data were collected at baseline and every 6 months for 2 years. Convergent validity was assessed by examining the strength of associations between clinical/psychological measures and EQ-5D scores. A responder analysis using generalized estimating equation models was used to evaluate the EQ-5D's sensitivity to changes in clinical/psychological factors over time.
Results
Among 221 individuals analyzed, HbA1c and SBP levels did not differ across those reporting varying levels of problems in any EQ-5D dimension. Individuals with higher BMI were more likely to report problems with mobility, usual activities, pain/discomfort, and anxiety/depression. DDS4 scores were moderately correlated with EQ-5D anxiety/depression dimension and index score, while PHQ-9 scores were strongly correlated with both. EQ-5D index score was insensitive to improvements in clinical measures but sensitive to improvements in psychological measures over time.
Conclusion
The EQ-5D-3L captured variations in BMI and psychological measures but not in HbA1c and SBP. This study provides HRQL estimates that can be compared with other populations or studies.No embarg
Impact of lifting school mask mandates on community SARS-CoV-2 cases, hospitalizations, and deaths: a retrospective observational study
Full text linkBackground: School masking mandates were widely adopted as a pandemic control measure, however, limited data are available regarding their effectiveness as a strategy for reducing burden of disease in the surrounding community.
Objective: To evaluate the impact of school masking policy de-adoption (mask-lifting) on SARS-CoV-2 incidence rates, hospitalizations, and deaths in the surrounding community.
Methods: Design: Retrospective observational study with an event study design, a difference-in-difference method; a target trial emulation (TTE) framework was applied as a secondary analysis. Cohort creation: Data collected from 9/2021 to 6/2022 on SARS-CoV-2 cases, hospitalizations, deaths and vaccination rates were combined with district-level masking policy data. Analysis: In the event study, the impact of masking policy de-adoption on SARS-CoV-2 cases per 100,000 county residents stratified by age during the 8-week period following the policy change was estimated. Effects on hospitalization and deaths per 1,000,000 residents were secondarily estimated. In a secondary analysis, a target trial emulation framework was applied to estimate average treatment effects.
Results: N = 3,970 districts composed of 53,453 schools were included in the cohort. In the event study, no consistent trends for COVID-19 case rates were identified for the whole cohort or for any age group. For the whole cohort, there was a statistically significant increase found 6-8 weeks following the policy change (maximum increase, 1.91 hospitalizations per 1,000,000 county residents); increases in hospitalizations were also found in the stratified analysis for all age groups, although absolute impacts were small. An increase in deaths was found during the period from 4 to 7 weeks following the policy change (maximum increase 0.62 deaths per 1,000,000 residents). In the stratified analysis, small increases in death rates were seen in 50-69 year olds (range, 0.088-1.49) and >70 year olds (range, 0.23-2.58) but not in younger groups. In the TTE framework, cases, hospitalizations, and deaths were similar in control and intervention counties.
Conclusion: This study evaluating the impact of lifting of mask mandates in schools, analyzed in two ways, was consistent results ranging from no impact to a small but statistically significant impact of the policy change on SARS-CoV-2 case and severe outcomes rates in the surrounding community. Findings can be used to inform future pandemic policy responses for elementary and secondary schoolsNo embarg
Multicenter comparative analysis of FRED-X, pipeline shield, and surpass evolve in treating intracranial aneurysms
No full textBackground
In recent years, newer flow diverters have been developed with surface modification and varying wire densities. Our study evaluated outcomes among three newer generation flow diverter devices, FRED-X, PED Shield and Surpass Evolve.
Methods
This was a retrospective study of patients from five participating institutions across the United States. Patients who underwent flow diversion of intracranial aneurysms using the FRED-X, PED Shield or Surpass Evolve between February 2022 and September 2024 were included. Outcomes of interest were technical success, angiographic occlusion and in-stent stenosis (ISS).
Results
Among 447 patients with 452 aneurysms, adjunct device use was highest with Surpass Evolve (36.4%) versus PED Shield (15.7%) and FRED-X (6.4%) (p < .001). Good wall apposition after angioplasty/stenting was most frequent with Surpass Evolve (32.3%) versus PED Shield (13.7%) and FRED-X (4.5%) (p < .001). At six months, complete occlusion was achieved in 69.3% (PED Shield), 63.6% (FRED-X), and 58% (Surpass Evolve) (p = .254). ISS rates were comparable at six months (p = .826). At 12 months, complete occlusion was observed in 78.9% of PED Shield, 68.4% of FRED-X, and 64.5% of Surpass Evolve aneurysms. Most ISS cases at 12 months were mild. Kaplan-Meier analysis showed no significant difference in occlusion rates (p = .914).
Conclusions
Flow diversion using FRED-X, PED Shield and Surpass Evolve resulted in comparable rates of angiographic occlusion and ISS. However, adjunctive devices were more commonly needed with Surpass Evolve.No embarg
Promotion of COVID-19 vaccination for youth and families in Worcester, Massachusetts: a Diffusion of Innovations approach
Full text linkIntroduction: Diffusion of innovations (DOI) theory can explain adoption of new technologies, like COVID-19 vaccines. We used an adapted version of DOI theory to guide efforts to adapt and implement evidence-based interventions to support COVID-19 vaccination for youth and families.
Methods: Guided by community partner input, we triangulated data on infection and vaccination rates with qualitative focus group and interview data, and a synthesis of literature on evidence-based interventions for vaccine promotion to adapt interventions.
Results: Implemented in three phases, we relied on trusted messengers to share vaccine narratives and tailored the degree of interaction between trusted messengers and adopters. We began broadly in the form of a community-wide communications campaign and progressively narrowed in focus towards direct engagement with trusted messengers.
Discussion: DOI framework can be used to plan for and implement interventions as demonstrated by our two-year project to respond to the ever-evolving context of the COVID-19 pandemic.No embarg
Deep learning-based aberration compensation improves contrast and resolution in fluorescence microscopy
Full text linkOptical aberrations hinder fluorescence microscopy of thick samples, reducing image signal, contrast, and resolution. Here we introduce a deep learning-based strategy for aberration compensation, improving image quality without slowing image acquisition, applying additional dose, or introducing more optics. Our method (i) introduces synthetic aberrations to images acquired on the shallow side of image stacks, making them resemble those acquired deeper into the volume and (ii) trains neural networks to reverse the effect of these aberrations. We use simulations and experiments to show that applying the trained 'de-aberration' networks outperforms alternative methods, providing restoration on par with adaptive optics techniques; and subsequently apply the networks to diverse datasets captured with confocal, light-sheet, multi-photon, and super-resolution microscopy. In all cases, the improved quality of the restored data facilitates qualitative image inspection and improves downstream image quantitation, including orientational analysis of blood vessels in mouse tissue and improved membrane and nuclear segmentation in C. elegans embryos.No embarg
"It's Harder to Chase Pain Than It Is to Prevent It": Perinatal Individual and Care Professional Attitudes Towards Preventing Perinatal Mood and Anxiety Disorders in Obstetric Settings
No full textPurpose: Depression and anxiety disorders are prevalent in the perinatal period and disproportionately impact individuals who experience economic marginalization. <15% of at-risk individuals are referred for recommended preventative counseling interventions. Little is known about the attitudes of care professionals and perinatal individuals towards prevention. This study's objective was to elicit attitudes of perinatal care professionals and individuals with lived experience of perinatal depression and anxiety who have been marginalized due to their economic status towards prevention interventions for perinatal mood and anxiety disorders in routine perinatal care settings.
Methods: We conducted semi-structured qualitative interviews with economically marginalized individuals with lived experience of perinatal anxiety or depression (n = 12) and perinatal care professionals (n = 12). We used a thematic analysis approach for data analysis.
Results: Participants endorsed generally positive attitudes towards prevention. Both individuals and professionals identified gaps in current practices and expressed interest in prevention because they felt that it could improve outcomes. Both groups described skepticism that prevention is possible. Perinatal individuals also described concerns about professional capacity, stigma, and medical mistrust while professionals had concerns about potential for harm and resource limitations. Participants emphasized the importance of professional-patient relationships and multidisciplinary teams in effective delivery of prevention care.
Conclusions: Current approaches to prevention of mood and anxiety disorders in the perinatal period are lacking. Integration of prevention into routine obstetric care is of interest to perinatal individuals and professionals as a strategy to improve outcomes and reduce care inequities. Improving education and awareness of prevention interventions may reduce skepticism towards these interventions. Steps to build communication and trust between patients and professionals are needed to improve comfort and engagement with prevention interventions.No embarg
Facilitators and barriers to reach and enrollment into a medically tailored meals program within a section 1115 Medicaid pilot: clinic staff perspectives
Full text linkIntroduction: Medically tailored meals (MTMs) are home-delivered, nutritionally tailored meals for individuals living with complex or advanced diet-sensitive medical conditions. In 2020, Massachusetts Medicaid implemented the Flexible Services Program (FSP) through a Section 1115 Demonstration, which funded novel nutrition programs, including MTMs, for high-risk patients through Accountable Care Organizations (ACOs). Little is known from the practitioners' perspective regarding the facilitators and barriers to reaching and enrolling patients in MTM programs.
Methods: We interviewed 19 staff across four ACOs that had implemented MTM interventions. Interviews were conducted from Feb to Aug 2023 and included staff who participated in patient screening, referral, or enrollment. The interview guide was informed by the Health Equity Implementation Framework. Interviews were recorded and transcribed and coded using NVivo software. We used directed qualitative content analyses. The study team identified and discussed common themes and presented them back to our ACO partners.
Results: Staff described facilitators of and barriers to reach and enrollment related to several domains of the Health Equity Implementation Framework. For program (innovation) factors, facilitators included perceived positive effects on patient health outcomes and a relative advantage over both the status quo and other nutrition assistance programs; outreach by care team members rather than other staff; the eligibility criteria, which were viewed as appropriate and evidence-based; and the simplicity of the program, which aided communication with patients. Patient-related facilitators included patients being more in need of the program due to more severe illness and being more motivated to change dietary behaviors. Patient-related barriers included lacking a working phone or stable housing and concern about meals meeting taste and cultural food preferences. Staff-related barriers included limited time and especially knowledge about the MTM program.
Discussion: This study highlights the perspectives of front-line staff during the implementation of an MTM program in a state-wide 1,115 Demonstration. Staff may require multiple trainings to gain full knowledge about the program and increase self-efficacy in describing it with sensitivity. These new findings elevate voices from front-line healthcare staff in MTM delivery and can help inform strategies for effective, equitable implementation of MTM programs.No embarg
Activation of the ciliary kinase CDKL5 is mediated by the cyclin-dependent kinase CDK20/LF2 to control flagellar length
Full text linkVariants in the protein kinase CDKL5 cause CDKL5 Deficiency Disorder (CDD), a severe neurodevelopmental condition characterized by seizures, developmental delay, and intellectual disability. The Chlamydomonas homolog of CDKL5, LF5, is a flagellar protein whose loss leads to elongated flagella. Here, we combine live-cell imaging, immunofluorescence, and biochemical approaches including mass spectrometry to define how CDKL5 activity is regulated and how its loss alters ciliary function. We find that Chlamydomonas CDKL5 is activated by LF2, a cyclin-dependent kinase, through phosphorylation of its activation loop. This activation controls CDKL5 localization in steady-state cilia, down-regulates its IFT-mediated transport as flagella reach steady-state, controls ciliary abundance of IFT proteins, and controls phosphorylation of the tubulin-binding domain of IFT74, thereby influencing flagellar length. Mouse Cdkl5 shows similar properties: it localizes within cilia, its loss leads to ciliary elongation, and its localization depends on both its kinase activity and Cdk20, the mammalian ortholog of LF2. These results extend our understanding of ciliary length control, challenge the prevailing model that CDKL5 is activated by autophosphorylation, and suggest that CDD pathogenesis arises, at least in part, from disruption of this conserved ciliary regulatory pathway.No embarg
The Reporting and Methodological Recommendations for Observational Studies Estimating the Effects of Deprescribing Medications (REMROSE-D) ISPE-Endorsed Guidance
Full text linkPurpose: Pharmacoepidemiologic studies on deprescribing are challenging to implement, yet little guidance exists on methods to avoid bias and minimum reporting for replicability and appraisal. We developed consensus recommendations for the methods and reporting of observational studies that aim to examine the effects of deprescribing.
Methods: We formed candidate recommendations based on our prior systematic review that methodologically appraised observational studies on deprescribing. We then conducted a two-round modified Delphi process with researchers working in deprescribing pharmacoepidemiology to refine, select, and reach consensus on recommendations for a checklist based on > 70% agreement of their importance. We termed this list the REMROSE-D (Reporting and Methodological Recommendations for Observational Studies estimating the Effects of Deprescribing medications) guidance.
Results: Twenty-three candidate recommendations were presented to the Delphi panel. The round 1 survey was completed by 55 participants, and 18 of the 23 candidate recommendations were selected for inclusion. Five candidate recommendations without consensus plus two additional items suggested by participants were included in a round 2 survey of 25 deprescribing researchers. Five of these seven items garnered consensus for inclusion, and two were excluded. The final REMROSE-D guidance contains 23 recommendations for the methods and reporting of observational research on deprescribing.
Conclusion: To ensure rigor and reproducibility in observational studies of the effects of deprescribing, the REMROSE-D guidance provides recommendations for important reporting and methods considerations, including time zero, precise definitions of deprescribing, addressing confounding by indication, and careful consideration of follow-up to avoid immortal time bias.No embarg