Category: Statistics

J Am Med Inform Assoc. 2024 Nov 14:ocae270. doi: 10.1093/jamia/ocae270. Online ahead of print.

ABSTRACT

OBJECTIVES: The NIH All of Us Research Program (All of Us) is engaging a diverse community of more than 10 000 registered researchers using a robust engagement ecosystem model. We describe strategies used to build an ecosystem that attracts and supports a diverse and inclusive researcher community to use the All of Us dataset and provide metrics on All of Us researcher usage growth.

MATERIALS AND METHODS: Researcher audiences and diversity categories were defined to guide a strategy. A researcher engagement strategy was codeveloped with program partners to support a researcher engagement ecosystem. An adapted ecological model guided the ecosystem to address multiple levels of influence to support All of Us data use. Statistics from the All of Us Researcher Workbench demographic survey describe trends in researchers’ and institutional use of the Workbench and publication numbers.

RESULTS: From 2022 to 2024, some 13 partner organizations and their subawardees conducted outreach, built capacity, or supported researchers and institutions in using the data. Trends indicate that Workbench registrations and use have increased over time, including among researchers underrepresented in the biomedical workforce. Data Use and Registration Agreements from minority-serving institutions also increased.

DISCUSSION: All of Us built a diverse, inclusive, and growing research community via intentional engagement with researchers and via partnerships to address systemic data access issues. Future programs will provide additional support to researchers and institutions to ameliorate All of Us data use challenges.

CONCLUSION: The approach described helps address structural inequities in the biomedical research field to advance health equity.

PMID:39545358 | DOI:10.1093/jamia/ocae270

J Glob Health. 2024 Nov 15;14:04206. doi: 10.7189/jogh.14.04206.

ABSTRACT

BACKGROUND: Social norms shape adolescent sexual and reproductive health behaviours contributing to contraceptive and pregnancy outcomes. No global research agendas exist to guide research on adolescent social norms shifting in low- and middle-income countries (LMICs). We developed a social norms research agenda to improve adolescent healthy timing and spacing of pregnancy in LMICs.

METHODS: We adapted and applied the Child Health and Nutrition Research Initiative (CHNRI) method. A group of researchers guided the process, and consulted with diverse experts to develop a list of 21 research questions for global stakeholders to score via an online survey. Survey participants scored each research question according to four criteria (fills key gap, feasible, impactful, equitable). Research priority scores (RPS) and average expert agreement (AEA) statistics were calculated for each question and analysed overall and by stakeholder region and profession.

RESULTS: We received 185 survey responses. Participants were, on average, 44 years old, 64% were women, 70% were from LMICs and 47% were implementers. The RPS ranged from 52 to 81% (74% median) and the AEA ranged from 49 to 70% (58% median). Nearly 70% of stakeholders gave the same score to each of the top five research questions. The top five research priorities focused on effective norm-shifting interventions (NSIs) strategies, processes and indicators to NSIs, and NSI adaptation and scale-up.

CONCLUSIONS: Using a collaborative and rigorous process with diverse representation from LMICs and implementers, we reached consensus on five priority research questions to guide future adolescent social norms research to improve healthy timing and spacing of pregnancy in LMICs.

PMID:39545342 | DOI:10.7189/jogh.14.04206

Biomol Biomed. 2024 Nov 13. doi: 10.17305/bb.2024.10808. Online ahead of print.

ABSTRACT

Massive hemoptysis is a life-threatening complication in patients with advanced primary lung cancer, and effective, safe treatments are crucial. This study aimed to investigate the efficacy and safety of CalliSpheres drug-eluting bead bronchial arterial infusion chemoembolization (DEB-BACE) for managing this condition. A retrospective analysis included 144 patients with advanced primary lung cancer and massive hemoptysis treated at multiple hospitals from January 2019 to January 2023. Patients undergoing bronchial artery embolization were divided into two groups: the observation group (n=76) received CalliSpheres DEB-BACE with epirubicin, and the control group (n=68) received 8spheres blank embolization. Both groups achieved successful hemostasis, with no statistically significant difference in success rates (observation group: 88.16%, control group: 86.76%). However, the observation group had a significantly longer median duration without hemoptysis (96 days vs. 50 days). Two months post-therapy, the observation group showed higher objective response rates (82.89% vs. 38.24%) and disease control rates (92.11% vs. 66.18%) compared to the control group. Adverse reactions were manageable and similar between groups, with no serious complications observed. By January 31, 2024, the observation group had significantly longer median overall survival (11 months vs. 7 months). The DEB-BACE treatment demonstrates safety and efficacy in managing massive hemoptysis in patients with advanced lung cancer. However, the superiority of this approach over bland embolization remains to be established through well-designed prospective studies. Future research is anticipated to provide a definitive comparison and further validate the role of DEB-BACE in clinical practice.

PMID:39545322 | DOI:10.17305/bb.2024.10808

J Magn Reson Imaging. 2024 Nov 15. doi: 10.1002/jmri.29663. Online ahead of print.

ABSTRACT

BACKGROUND: Epilepsy is the most common preoperative symptom in patients with supratentorial gliomas. Identifying tumor locations and clinical factors associated with preoperative epilepsy is important for understanding seizure risk.

PURPOSE: To investigate the key brain areas and risk factors associated with preoperative seizures in glioma patients.

STUDY TYPE: Retrospective.

POPULATION: A total of 735 patients with primary diffuse supratentorial gliomas (372 low grade; 363 high grade) with preoperative MRI and pathology data.

FIELD STRENGTH/SEQUENCE: Axial T2-weighted fast spin-echo sequence at 3.0 T.

ASSESSMENT: Seizure burden was defined as the number of preoperative seizures within 6 months. Tumor and high-signal edema areas on T2 images were considered involved regions. A voxel-based lesion-symptom mapping analysis was used to identify voxels associated with seizure burden. The involvement of peak voxels (those most associated with seizure burden) and clinical factors were assessed as risk factors for preoperative seizure.

STATISTICAL TESTS: Univariable and multivariable binary and ordinal logistic regression analyses and chi-square tests were performed, with results reported as odds ratios (ORs) and 95% confidence intervals. A P-value <0.05 was considered significant.

RESULTS: A total of 448 patients experienced preoperative seizures. Significant seizure burden-related voxels were located in the right hippocampus and left insular cortex (based on 1000 permutation tests), with significant differences observed in both low- and high-grade tumors. Tumor involvement in the peak voxel region was an independent risk factor for an increased burden of preoperative seizures (OR = 6.98). Additionally, multivariable binary logistic regression results indicated that 1p/19q codeletion (OR = 1.51), intermediate tumor volume (24.299-97.066 cm³), and involvement of the peak voxel (OR = 6.06) were independent risk factors for preoperative glioma-related epilepsy.

CONCLUSION: Voxel areas identified through voxel-based lesion-symptom mapping analysis, along with clinical factors, show associations with clinical seizure burden, offering insights for assessing seizure burden for glioma patients.

LEVEL OF EVIDENCE: 4 TECHNICAL EFFICACY: Stage 1.

PMID:39545320 | DOI:10.1002/jmri.29663

Clin Cardiol. 2024 Nov;47(11):e70043. doi: 10.1002/clc.70043.

ABSTRACT

INTRODUCTION: Patients with small vessels who undergo percutaneous coronary intervention (PCI) with subsequent multiple implantation of drug-eluting stents remain at a higher risk of unfavorable outcomes. In complex cases where maintaining flow to all side branches is part of contemporary practice, using two-stent techniques may be appropriate. This study aims to evaluate the efficacy of double-kissing (DK) culotte technique in comparison to culotte technique in the context of small-vessel therapy in patients with acute coronary syndrome (ACS).

METHODS: This substudy of the Lower Silesia culotte Bifurcation Registry retrospectively analyzed patients who underwent ACS-PCI using DK culotte or culotte technique for bifurcation lesions in small vessels, defined as having at least one branch with a diameter of 2.75 mm or less. The primary endpoint was target lesion failure (TLF), a composite of cardiovascular death, target vessel myocardial infarction, or clinically driven target lesion revascularization (TLR) at 1-year follow-up. The secondary endpoint included major adverse cardiac events (MACE).

RESULTS: The DK culotte group (n = 49) and the culotte group (n = 52) were compared, with 12-month follow-up showing lower TLF in the DK culotte group (8.2% vs. 19.2%, p = 0.082). Similar results were observed for TLR (6.1% vs. 13.5%; p = 0.161), stent restenosis (4.1% vs. 9.6%; p = 0.203), and MACE (18.4% vs. 25%; p = 0.344).

CONCLUSION: For bifurcation lesions with a small-diameter artery, the DK culotte technique may reduce TLF and MACE compared to the culotte technique. However, given the limited sample size and the absence of statistical significance, these findings remain preliminary and require further investigation.

PMID:39545312 | DOI:10.1002/clc.70043

West Afr J Med. 2024 Nov 10;41(11 Suppl 1):S54-S55.

ABSTRACT

BACKGROUND: Sickle cell disease (SCD) is highly prevalent in Africa, especially in Nigeria, the most populous country, and is associated with a high mortality rate. Depression, common among individuals with SCD, correlates with increased pain intensity and opioid misuse, leading to poorer outcomes and diminished quality of life in these patients.

AIM: To determine whether major depressive disorder is a predictor of opioid use disorder among patients with sickle cell disease.

MATERIALS AND METHODS: This cross-sectional study was conducted at UDUTH Sokoto and employed psychometric instruments to evaluate patients with SCD. A systematic sampling technique was utilized, and data analyzed using SPSS version 25. Chi-square tests and regression analysis were employed to assess associations and identify predictors, respectively.

RESULTS: The study found statistically significant associations between opioid use disorder (OUD) and the lack of insurance services (p-value = 0.008), major depressive disorder (p-value < 0.001), and elevated pain scores (p-value = 0.003), but not with hemoglobin type (p-value = 0.229). OUD was also more prevalent among respondents with moderate to severe depression (p-value = 0.017). However, only major depressive disorder was identified as a predictor of OUD (AOR: 0.174, 95% CI: 0.067-0.452, p-value < 0.001).

CONCLUSION: The study identified major depressive disorder as a predictor of among patients with SCD, this underscores the necessity for routine depression screening and timely intervention in this population.

PMID:39545309

East Mediterr Health J. 2024 Jul 17;30(6):430-439. doi: 10.26719/2024.30.6.430.

ABSTRACT

BACKGROUND: Health systems research and publication are vital for improving healthcare at all levels of care. They provide evidence for policy and for better service outcomes.

AIMS: To assess published health systems research in Pakistan from 2011 to 2020 and to model and forecast the publication trend.

METHODS: This cross-sectional study searched health systems research publications database for Pakistan in Scopus using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Tables and graphs were created using Microsoft Excel, visualization was produced on VoS Viewer, and SPSS version 29.1.0 was used for analysis, while R software was used to plot the time series data.

RESULTS: A total of 697 articles with an average of 16.6 citations were published between 2011 and 2020. The highest number of publications (240) per single institution was from Aga Khan University (including Aga Khan University Hospital), Karachi. There was a significant difference between the number of publications before and after the midpoint (2015) of the bibliometric analysis (t = -3.08, P = 0.015, 95% CI -87.78–12.61). We observed a strong relationship between publications and citations over the same period (Correlation coefficient 0.809, P = 0.002, CI 0.46-0.98) but there was no significant difference between the number of citations before and after the midpoint.

CONCLUSION: There was an acute dearth of health systems research publication at the beginning of the study period. A few medical institutes are now taking the lead in conducting and publishing health systems research. Technical and financial support is needed to strengthen the capacity of Pakistani medical institutions and researchers to contribute more to knowledge generation within the country.

PMID:39545293 | DOI:10.26719/2024.30.6.430

Bone Jt Open. 2024 Nov 15;5(11):1037-1040. doi: 10.1302/2633-1462.511.BJO-2024-0116.R1.

ABSTRACT

AIMS: The first metatarsal pronation deformity of hallux valgus feet is widely recognized. However, its assessment relies mostly on 3D standing CT scans. Two radiological signs, the first metatarsal round head (RH) and inferior tuberosity position (ITP), have been described, but are seldom used to aid in diagnosis. This study was undertaken to determine the reliability and validity of these two signs for a more convenient and affordable preoperative assessment and postoperative comparison.

METHODS: A total of 200 feet were randomly selected from the radiograph archives of a foot and ankle clinic. An anteroposterior view of both feet was taken while standing on the same x-ray platform. The intermetatarsal angle (IMA), metatarsophalangeal angle (MPA), medial sesamoid position, RH, and ITP signs were assessed for statistical analysis.

RESULTS: There were 127 feet with an IMA > 9°. Both RH and ITP severities correlated significantly with IMA severity. RH and ITP were also significantly associated with each other, and the pronation deformities of these feet are probably related to extrinsic factors. There were also feet with discrepancies between their RH and ITP severities, possibly due to intrinsic torsion of the first metatarsal.

CONCLUSION: Both RH and ITP are reliable first metatarsal pronation signs correlating to the metatarsus primus varus deformity of hallux valgus feet. They should be used more for preoperative and postoperative assessment.

PMID:39545268 | DOI:10.1302/2633-1462.511.BJO-2024-0116.R1

J Pharm Technol. 2024 Oct 22:87551225241288137. doi: 10.1177/87551225241288137. Online ahead of print.

ABSTRACT

BACKGROUND: Dexmedetomidine is a centrally acting alpha-2-adrenoceptor agonist that is usually used in the intensive care unit (ICU) for its sedative, analgesic, and anxiolytic properties. Studies have shown that dexmedetomidine can be an effective adjunct analgesic, but they are limited and usually use a population of intubated patients. To better evaluate the role of dexmedetomidine use in the adult ICU, more information needs to be gathered on its analgesic effect and its utility in non-intubated patients.

METHODS: This study was a retrospective cohort analysis between adult non-intubated ICU patients on dexmedetomidine and non-intubated ICU patients not on dexmedetomidine who were admitted to a 302-bed tertiary academic medical center between October 1, 2022, and August 31, 2023. Inclusion criteria necessitated an as-needed opioid order with a corresponding pain score and at least 1 other pain assessment and no history of symptomatic bradycardia, nor could it be present on admission. The primary study objective was to assess the amount of morphine milligram equivalents (MMEs) received during ICU admission with concomitant dexmedetomidine infusion. Secondary outcomes included the time to first dose of rescue opioid analgesia and ICU length of stay.

RESULTS: A total of 38 patients were included. Baseline demographics did not differ significantly between groups. There was a significant statistical difference in the total amount of MMEs received, with the dexmedetomidine group having significantly less than the control group (P < 0.001). The dexmedetomidine group also had a significantly longer time to first rescue analgesia dose (P = 0.025) and a significantly increased incidence of delirium (P < 0.001). There was no difference in other adverse events between groups.

CONCLUSION: Dexmedetomidine significantly decreased MME requirements and increased time to first rescue analgesia dose in non-intubated ICU patients without increasing adverse effects but was associated with an increased incidence of delirium.

PMID:39545245 | PMC:PMC11559726 | DOI:10.1177/87551225241288137

J Pharm Technol. 2024 Nov 5:87551225241289959. doi: 10.1177/87551225241289959. Online ahead of print.

ABSTRACT

BACKGROUND: No head-to-head comparisons of semaglutide formulations currently exist in the literature. In practice, many may think that oral and injectable semaglutide formulations are interchangeable, although there is currently limited real-world data to determine whether this is accurate.

OBJECTIVE: The purpose of this study was to determine the effect of oral versus injectable semaglutide on hemoglobin A_1C (HbA_1C) and weight in patients with type 2 diabetes (T2D).

METHODS: This was a retrospective single-center review of adult patients who had a diagnosis of T2D and were treated with oral or injectable semaglutide between November 1, 2019, and July 31, 2022. Primary outcome was a comparison of changes in HbA_1C (%) and weight (kg) from baseline to 6 months between patients receiving oral versus injectable semaglutide, stratified according to highest dose received. Secondary outcomes included frequency of dose reductions and discontinuations, achievement of clinical goals, and presence of an embedded clinical pharmacist at patients’ primary care office.

RESULTS: A total of 105 patients were included. Patients experienced mean decreases in HbA_1C and weight from baseline to 6 months of -1.75% (P < 0.001) and -3.64 kg (P = 0.015), respectively, in the oral semaglutide group and -1.35% (P < 0.001) and -5.26 kg (P < 0.001), respectively, in the injectable semaglutide group. When directly comparing semaglutide formulations, oral semaglutide demonstrated a 0.4% greater numerical reduction in HbA_1C (P = 0.523) and injectable semaglutide demonstrated a 1.62-kg greater numerical reduction in weight (P = 0.312). Adverse events (AEs) occurred more frequently with oral semaglutide than with injectable semaglutide (16.7% vs 4.9%). Discontinuation due to AEs was more common with oral semaglutide.

CONCLUSION: In this study, patients with T2D who received oral semaglutide demonstrated greater reductions in HbA_1C, whereas those treated with injectable semaglutide had greater reductions in weight, although there were no statistically significant reductions in HbA_1C or weight between the 2 formulations. Rates of AEs and discontinuation were more common in the oral semaglutide group.

PMID:39545243 | PMC:PMC11559783 | DOI:10.1177/87551225241289959