Category: Statistics

JAMA Netw Open. 2024 Jul 1;7(7):e2421547. doi: 10.1001/jamanetworkopen.2024.21547.

NO ABSTRACT

PMID:38995647 | DOI:10.1001/jamanetworkopen.2024.21547

JAMA Netw Open. 2024 Jul 1;7(7):e2419881. doi: 10.1001/jamanetworkopen.2024.19881.

ABSTRACT

IMPORTANCE: Excessive screen media use has been associated with poorer mental health among children and adolescents in several observational studies. However, experimental evidence supporting this hypothesis is lacking.

OBJECTIVE: To investigate the effects of a 2-week screen media reduction intervention on children’s and adolescents’ mental health.

DESIGN, SETTING, AND PARTICIPANTS: This prespecified secondary analysis of a cluster randomized clinical trial with a 2-week follow-up included 89 families (with 181 children and adolescents) from 10 Danish municipalities in the region of Southern Denmark. All study procedures were carried out in the home of the participants. Enrollment began on June 6, 2019, and ended on March 30, 2021. This analysis was conducted between January 1 and November 30, 2023.

INTERVENTION: Families were randomly allocated to a screen media reduction group or a control group. The 2-week screen media reduction intervention was designed to ensure a high level of compliance to the reduction in leisure-time screen media use. Participants allocated to the intervention group had to reduce their leisure-time screen media use to 3 hours per week or less per person and hand over smartphones and tablets.

MAIN OUTCOMES AND MEASURES: The main outcome was the between-group mean difference in change in total behavioral difficulties, measured by the Strengths and Difficulties Questionnaire at 2-week follow-up. Results were estimated using mixed-effects tobit regression models. Analyses were carried out as both intention to treat and complete case.

RESULTS: In the sample of 89 families including 181 children and adolescents (intervention group [45 families]: 86 children; mean [SD] age, 8.6 [2.7] years; 42 girls [49%]; control group [44 families]: 95 children; mean [SD] age, 9.5 [2.5] years; 57 girls [60%]), there was a statistically significant between-group mean difference in the total difficulties score, favoring the screen media reduction intervention (-1.67; 95% CI, -2.68 to -0.67; Cohen d, 0.53). The greatest improvements were observed for internalizing symptoms (emotional symptoms and peer problems; between-group mean difference, -1.03; 95% CI, -1.76 to -0.29) and prosocial behavior (between-group mean difference, 0.84; 95% CI, 0.39-1.30).

CONCLUSIONS AND RELEVANCE: This secondary analysis of a randomized clinical trial found that a short-term reduction in leisure-time screen media use within families positively affected psychological symptoms of children and adolescents, particularly by mitigating internalizing behavioral issues and enhancing prosocial behavior. More research is needed to confirm whether these effects are sustainable in the long term.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04098913.

PMID:38995646 | DOI:10.1001/jamanetworkopen.2024.19881

JAMA Netw Open. 2024 Jul 1;7(7):e2420458. doi: 10.1001/jamanetworkopen.2024.20458.

ABSTRACT

IMPORTANCE: The COVID-19 pandemic created unprecedented challenges for clinical trials worldwide, threatening premature closure and trial integrity. Every phase of research operations was affected, often requiring modifications to protocol design and implementation.

OBJECTIVES: To identify the barriers, solutions, and opportunities associated with continuing critical care trials that were interrupted during the pandemic, and to generate suggestions for future trials.

DESIGN, SETTING, AND PARTICIPANTS: This mixed-methods study performed an explanatory sequential analysis involving a self-administered electronic survey and focus groups of principal investigators (PIs) and project coordinators (PCs) conducting adult and pediatric individual-patient randomized trials of the Canadian Critical Care Trials Group during the COVID-19 pandemic. Eligible trials were actively enrolling patients on March 11, 2020. Data were analyzed between September 2023 and January 2024.

MAIN OUTCOMES AND MEASURES: Importance ratings of barriers to trial conduct and completion, solutions employed, opportunities arising, and suggested strategies for future trials. Quantitative data examining barriers were analyzed using descriptive statistics. Data addressing solutions, opportunities, and suggestions were analyzed by qualitative content analysis. Integration involved triangulation of data sources and perspectives about 13 trials, synthesized by an interprofessional team incorporating reflexivity and member-checking.

RESULTS: A total of 13 trials run by 29 PIs and PCs (100% participation rate) were included. The highest-rated barriers (on a 5-point scale) to ongoing conduct during the pandemic were decisions to pause all clinical research (mean [SD] score, 4.7 [0.8]), focus on COVID-19 studies (mean [SD] score, 4.6 [0.8]), and restricted family presence in hospitals (mean [SD] score, 4.1 [0.8]). Suggestions to enable trial progress and completion included providing scientific leadership, implementing technology for communication and data management, facilitating the informed consent process, adapting the protocol as necessary, fostering site engagement, initiating new sites, streamlining ethics and contract review, and designing nested studies. The pandemic necessitated new funding opportunities to sustain trial enrollment. It increased public awareness of critical illness and the importance of randomized trial evidence.

CONCLUSIONS AND RELEVANCE: While underscoring the vital role of research in society and drawing the scientific community together with a common purpose, the pandemic signaled the need for innovation to ensure the rigor and completion of ongoing trials. Lessons learned to optimize research procedures will help to ensure a vibrant clinical trials enterprise in the future.

PMID:38995645 | DOI:10.1001/jamanetworkopen.2024.20458

JAMA Netw Open. 2024 Jul 1;7(7):e2421903. doi: 10.1001/jamanetworkopen.2024.21903.

ABSTRACT

IMPORTANCE: African American men experience greater prostate cancer incidence and mortality than White men. Growing literature supports associations of neighborhood disadvantage, which disproportionately affects African American men, with aggressive prostate cancer; chronic stress and downstream biological impacts (eg, increased inflammation) may contribute to these associations.

OBJECTIVE: To examine whether several neighborhood disadvantage metrics are associated with prostate tumor RNA expression of stress-related genes.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study leveraged prostate tumor transcriptomic data for African American and White men with prostate cancer who received radical prostatectomy at the University of Maryland Medical Center between August 1992 and January 2021. Data were analyzed from May 2023 to April 2024.

EXPOSURES: Using addresses at diagnosis, 2 neighborhood deprivation metrics (Area Deprivation Index [ADI] and validated bayesian Neighborhood Deprivation Index) as well as the Racial Isolation Index (RI) and historical redlining were applied to participants’ addresses. Self-reported race was determined using electronic medical records.

MAIN OUTCOMES AND MEASURES: A total of 105 stress-related genes were evaluated with each neighborhood metric using linear regression, adjusting for race, age, and year of surgery. Genes in the Conserved Transcriptional Response to Adversity (CTRA) and stress-related signaling genes were included.

RESULTS: A total of 218 men (168 [77%] African American, 50 [23%] White) with a median (IQR) age of 58 (53-63) years were included. African American participants experienced greater neighborhood disadvantage than White participants (median [IQR] ADI, 115 [100-130] vs 92 [83-104]; median [IQR] RI, 0.68 [0.34-0.87] vs 0.11 [0.06-0.14]). ADI was positively associated with expression for 11 genes; HTR6 (serotonin pathway) remained significant after multiple-comparison adjustment (β = 0.003; SE, 0.001; P < .001; Benjamini-Hochberg q value = .01). Several genes, including HTR6, were associated with multiple metrics. We observed higher expression of 5 proinflammatory genes in the CTRA with greater neighborhood disadvantage (eg, CXCL8 and ADI, β = 0.008; SE, 0.003; P = .01; q value = .21).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study, the expression of several stress-related genes in prostate tumors was higher among men residing in disadvantaged neighborhoods. This study is one of the first to suggest associations of neighborhood disadvantage with prostate tumor RNA expression. Additional research is needed in larger studies to replicate findings and further investigate interrelationships of neighborhood factors, tumor biology, and aggressive prostate cancer to inform interventions to reduce disparities.

PMID:38995644 | DOI:10.1001/jamanetworkopen.2024.21903

JAMA Netw Open. 2024 Jul 1;7(7):e2422189. doi: 10.1001/jamanetworkopen.2024.22189.

ABSTRACT

IMPORTANCE: Adolescence is a critical developmental phase when mental health disorders, such as anxiety and depression, often emerge. Stringent public health measures and quarantine mandates during the COVID-19 pandemic could threaten adolescent mental health.

OBJECTIVE: To investigate the associations of public health measures and quarantine experiences with mental distress among Norwegian adolescents and to explore if certain vulnerability factors moderate these associations.

DESIGN, SETTING, AND PARTICIPANTS: This longitudinal cohort study used repeated measures to capture variations in mental distress explained by the stringency of public health measures and quarantine experiences. Data from the Norwegian Mother, Father, and Child cohort study were linked to national health registries and a national stringency index from April 1, 2020, to February 17, 2021. Participant included 7787 Norwegian adolescents aged 16 to 18 years. Data were analyzed from October 2022 to October 2023.

EXPOSURES: Stringency index of public health measures and quarantine experiences including recent quarantine (within the last 2 weeks) and quarantine frequency (cumulative number of quarantine episodes).

MAIN OUTCOME AND MEASURES: Mental distress was measured using the Hopkins Symptom Checklist across 6 data collection waves.

RESULTS: In this study, 7787 participants were included in the analysis (4473 female [57%]; mean [SD] age, 17.0 [0.6] years). Stringent public health measures (β = 0.18; SE, 0.02; P < .001), recent quarantine (β = 0.11; SE, 0.02; P < .001), and frequent quarantine (β = 0.08; SE, 0.01; P < .001) were associated with higher levels of mental distress. The associations between public health measures and mental distress were not moderated by sex, age, prepandemic anxiety or depression, or genetic liability for mental health conditions. Frequency of quarantine appeared to be more strongly associated with mental distress among younger adolescents (β = -0.04; SE, 0.01; P = .008), those with parents with lower education (β = -0.04; SE, 0.01; P = .007), and those with lower genetic risk for depression (β = -0.03; SE, 0.01; P = .006).

CONCLUSIONS AND RELEVANCE: In this study, younger adolescents, those with parents with lower education, or those with low genetic liability for depression appeared more vulnerable when being quarantined several times. These findings emphasize the need for targeted support strategies to better protect adolescent well-being during future crises. Adolescents who experienced increased mental distress during the COVID-19 pandemic may be at risk of continued mental health problems and in need of ongoing support.

PMID:38995642 | DOI:10.1001/jamanetworkopen.2024.22189

JAMA Health Forum. 2024 Jul 5;5(7):e241794. doi: 10.1001/jamahealthforum.2024.1794.

ABSTRACT

IMPORTANCE: Understanding mortality disparities among justice system-involved populations is crucial for public health and policy, especially for marginalized racial groups such as American Indian/Alaska Native persons.

OBJECTIVE: To examine racial disparities in mortality within the broader justice system-involved population in South Dakota, focusing on different sentencing dispositions and the role of place.

DESIGN, SETTING, AND PARTICIPANTS: This observational study used administrative criminal records linked to mortality data from January 2000 to December 2016. The statewide data linked data from South Dakota Attorney General’s Office and South Dakota Department of Health. Individuals aged 18 years and older with arrests were analyzed in this population-based sample. Data were analyzed from August 1, 2022, to July 30, 2023.

EXPOSURE: Sentencing dispositions were categorized as arrest only, fine, probation, jail, and prison.

MAIN OUTCOMES AND MEASURES: The main outcomes were mortality rates (both all-cause and cause-specific) calculated using Poisson regression models, adjusted for demographic and county variables.

RESULTS: Of 182 472 individuals with 422 987 arrests, the study sample included 29 690 American Indian/Alaska Native arrestees (17 900 [60%] male; mean [SD] age, 29.4 [11.0] years) and 142 248 White arrestees (103 471 [73%] male; mean [SD] age, 32.6 [12.9] years). American Indian/Alaska Native persons accounted for 16% of arrestees and 26% of arrests, but only 9% of the population in South Dakota. Across dispositions, mortality risk was greater for White individuals sentenced to probation, jail, and prison relative to White individuals who were arrested only. In terms of racial disparities, all-cause mortality risk was 2.37 (95% CI, 1.95-2.88) times higher for American Indian/Alaska Native than White arrestees in the arrest-only disposition. Disparities persisted across all dispositions but narrowed substantially for probation and prison. Results were similar for cause-specific mortality risk, except for cancer risk. In urban areas, mortality risk was 2.70 (95% CI, 1.29-2.44) times greater for American Indian/Alaska Native individuals relative to White individuals among those with arrest-only dispositions.

CONCLUSIONS AND RELEVANCE: In this population-based observational study, mortality risk and associated racial disparities among justice system-involved individuals differed substantially across dispositions and places, underscoring the need for public health interventions tailored to these factors. Further research is needed to understand the mechanisms through which sentencing and place shape these disparities.

PMID:38995634 | DOI:10.1001/jamahealthforum.2024.1794

Pain Ther. 2024 Jul 12. doi: 10.1007/s40122-024-00632-3. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim of this study is to examine the analgesic efficacy of varying doses of hydromorphone hydrochloride in conjunction with absorbable gelatin sponge for postoperative pain management in elderly individuals undergoing lumbar fusion surgery. Additionally, the study aims to assess the sustained release analgesic properties of this combination and to determine the optimal dosage of hydromorphone hydrochloride for effective pain relief.

METHODS: A total of 113 elderly patients (aged ≥ 65 years old) meeting the criteria for 1-2-level posterior lumbar fusion surgery at Ganzhou City People’s Hospital between July 2022 and August 2023 were randomly assigned to four groups: group A (0.2 mg hydromorphone hydrochloride 1 ml), group B (0.3 mg hydromorphone hydrochloride 1.5 ml), group C (0.4 mg hydromorphone hydrochloride 2 ml), and group D (0.9% normal saline 2 ml) for standard anesthesia induction and maintenance. Prior to suturing the incision, gelfoam was utilized to administer epidural analgesia to each group. Following the surgical procedure, an intravenous analgesia pump was utilized for pain management. The baseline infusion rate was set at 0.5 ml/h. Patient-controlled analgesia (PCA) was administered at a dose of 2 ml, with a lockout interval of 20 min, allowing the patient to self-administer as needed. Pain relief was assessed using the visual analogue scale (VAS) prior to surgery, as well as at 1 day and 3 days post-operation. The frequency of PCA requests within the initial 48-h postoperative period, the remedial analgesia with dezocine, postoperative adverse reactions, and duration of hospitalization were documented for analysis.

RESULTS: The VAS scores of groups B and C were found to be significantly lower than those of group D 1 day after the operation. Additionally, VAS scores at 3 days post-operation, remedial rate of dezocine and PCA follow-up times at 48 h in groups A, B, and C were significantly lower compared to group D (P < 0.001). There was no statistically significant difference between group B and group C in VAS scores at 1 day and 3 days post-operation, as well as PCA follow-up times at 48 h post-operation (P < 0.001). Furthermore, the VAS scores of groups B and C were lower than those of group A at 1 day and 3 days post-operation (P < 0.05). The PCA frequency of group C was also lower than that of group A at 48 h post-operation (P < 0.05).

CONCLUSION: The combination of hydromorphone hydrochloride and absorbable gelatin sponge epidural analgesia has been shown to enhance postoperative pain management. A dosage of 0.4 mg of hydromorphone hydrochloride may be considered an appropriate analgesic dose, as it can provide effective pain relief without eliciting adverse reactions.

TRIAL REGISTRATION: ChiCTR.org.cn(ChiCTR2200064863). Registered on October 20, 2022.

PMID:38995609 | DOI:10.1007/s40122-024-00632-3

Methods Mol Biol. 2024;2836:183-215. doi: 10.1007/978-1-0716-4007-4_11.

ABSTRACT

Metaproteomics has become a crucial omics technology for studying microbiomes. In this area, the Unipept ecosystem, accessible at https://unipept.ugent.be , has emerged as a valuable resource for analyzing metaproteomic data. It offers in-depth insights into both taxonomic distributions and functional characteristics of complex ecosystems. This tutorial explains essential concepts like Lowest Common Ancestor (LCA) determination and the handling of peptides with missed cleavages. It also provides a detailed, step-by-step guide on using the Unipept Web application and Unipept Desktop for thorough metaproteomics analyses. By integrating theoretical principles with practical methodologies, this tutorial empowers researchers with the essential knowledge and tools needed to fully utilize metaproteomics in their microbiome studies.

PMID:38995542 | DOI:10.1007/978-1-0716-4007-4_11

Methods Mol Biol. 2024;2836:67-76. doi: 10.1007/978-1-0716-4007-4_5.

ABSTRACT

Recently, HexNAcQuest was developed to help distinguish peptides modified by HexNAc isomers, more specifically O-linked β-N-acetylglucosamine (O-GlcNAc) and O-linked α-N-acetylgalactosamine (O-GalNAc, Tn antigen). To facilitate its usage (particularly for datasets from glycoproteomics studies), herein we present a detailed protocol. It describes example cases and procedures for which users might need to use HexNAcQuest to distinguish these two modifications.

PMID:38995536 | DOI:10.1007/978-1-0716-4007-4_5

Indian J Gastroenterol. 2024 Jul 12. doi: 10.1007/s12664-024-01630-1. Online ahead of print.

ABSTRACT

BACKGROUND AND AIM: Endoscopic retrograde cholangiopancreatography (ERCP) may help detect cholangiocarcinoma in patients with primary sclerosing cholangitis (PSC), but it may be associated with complications. This study was aimed at determining the prognostic impact of ERCP on patients with PSC without cholangitis.

METHODS: Patients with PSC without cholangitis were divided into two groups: those who underwent ERCP within three years after diagnosis (ERCP-performed group) and those who did not (non-ERCP group). These groups were compared in terms of clinical outcomes (liver-related death or liver transplantation, endoscopic treatment requirement and repeated cholangitis) and the composite outcome.

RESULTS: Of 99 patients with PSC with detailed medical history, 49 were included in the ERCP-performed group and 21 in the non-ERCP group. In Kaplan-Meier analysis, the non-ERCP group was less likely to achieve the three outcomes and the composite outcome, showing statistical significance (endoscopic treatment requirement; p = 0.017 and composite outcome; p = 0.014). A Cox proportional hazards model indicated that ERCP in the asymptomatic state was a significant predictor of endoscopic treatment requirement (hazard ratio [HR]: 4.37, 95% confidence interval [CI]: 1.03-18.59) and the composite outcome (HR: 4.54, 95% CI: 1.07-19.28).

CONCLUSION: ERCP in patients with PSC without cholangitis is likely to require further endoscopic treatment and may be associated with poor prognosis.

PMID:38995523 | DOI:10.1007/s12664-024-01630-1