Tag: nevin manimala

JAMA. 2024 Nov 27. doi: 10.1001/jama.2023.18494. Online ahead of print.

NO ABSTRACT

PMID:39602184 | DOI:10.1001/jama.2023.18494

J Am Coll Health. 2024 Nov 27:1-6. doi: 10.1080/07448481.2024.2427066. Online ahead of print.

ABSTRACT

Objective: The current study explored the relationships of religiosity and coping behaviors on the perceived mental health of undergraduate African American (AA) college students enrolled at a large public university in the Southern United States. Methods: We used a cross-sectional survey design. AA and/or African descent adult college participants (n = 131) were recruited from an online chat group (ie, GroupMe) and completed the Brief-COPE, a demographic questionnaire, and a single-item mental health tool. Data analyses employing descriptive statistics and correlational analyses examined relationships between variables. Results: There was a positive correlation between increased religious activity and overall mental health. Those who specified their religion as “other” had a lower total mental health score than those with an identified religion. Conclusions: Findings underscore the importance of supportive interventions that account for religious beliefs and activities on overall mental health outcomes for undergraduate AA college students in the South.

PMID:39602177 | DOI:10.1080/07448481.2024.2427066

J Plast Surg Hand Surg. 2024 Nov 27;59:153-161. doi: 10.2340/jphs.v59.42324.

ABSTRACT

Breast cancer can lead to changes in appearance and subsequent concerns about body image. This study aimed to translate the body investment instrument, Appearance Schemas Inventory-Revised (ASI-R), to Swedish, and perform a validation in women who underwent mastectomy and were awaiting breast reconstruction. The instrument was translated, and its psychometric properties were investigated according to current guidelines. Three hundred and ninety-seven women were eligible for the study, and 215 (54%) participants responded. An exploratory factor analysis (EFA) revealed that a three-factor structure was the most adequate solution. Three new subscales were suggested: body image investment cognition; breast and body image investment emotions; breast reflecting dysfunctional cognitive and emotional patterns of appearance investment and body image investment behaviors; breast reflecting positive ways of investing in body image. Consistent with previous findings, control over appearance is a central theme in women with breast cancer undergoing mastectomy and reconstruction. The obtained factor structure was considered similar to the original structure and three-factor solutions obtained from an American cohort of patients with breast cancer. The ASI-R has shown good psychometric properties in Swedish women undergoing mastectomy and reconstruction. Further studies on convergent validity and confirmatory factor analysis are required.

PMID:39602151 | DOI:10.2340/jphs.v59.42324

JAMA Surg. 2024 Nov 27. doi: 10.1001/jamasurg.2024.5227. Online ahead of print.

ABSTRACT

IMPORTANCE: Evidence suggests that prophylactic abdominal drainage after gastrectomy for cancer may reduce postoperative morbidity and hospital stay but this evidence comes from small studies with a high risk of bias. Further research is needed to determine whether drains safely meet their primary purpose of identifying and managing postoperative intraperitoneal collections without the need for reoperation or additional percutaneous drainage.

OBJECTIVE: To determine whether avoiding routine abdominal drainage increased postoperative invasive procedures.

DESIGN, SETTING, AND PARTICIPANTS: The Abdominal Drain in Gastrectomy (ADIGE) Trial was a multicenter prospective randomized noninferiority trial. Enrollment spanned from December 2019 to January 2023. Follow-up evaluations were completed at 30 and 90 days. Eleven centers within the Italian Research Group for Gastric Cancer, encompassing both academic medical centers and community hospitals, were included. Patients with gastric cancer undergoing subtotal or total gastrectomy with curative intent were eligible, excluding those younger than 18 years, with serious comorbidities, or undergoing procedure types outside the scope of the study. Of 803 patients assessed for eligibility, 404 were randomized and 390 were included in final analyses.

INTERVENTIONS: Patients were randomized 1:1 into prophylactic drain or no drain arms.

MAIN OUTCOMES AND MEASURES: The primary end point was a modified intention-to-treat (mITT) analysis measuring reoperation or percutaneous drainage within 30 postoperative days. The null hypothesis was rejected when the 90% CI upper limit of the proportion difference did not exceed 3.56%. The calculated sample size to achieve 80% power with a 10% dropout rate was 404 patients (202 in each group). Surgeons and patients were blinded until gastrointestinal reconstruction.

RESULTS: Of the 404 patients randomized 226 (57.8%) were male; the median (IQR) age was 71 (62-78) years. Intraoperative identification of nonresectable disease occurred in 14 patients, leading to their exclusion from the study, leaving 390 patients. In the mITT analysis, 15 patients (7.7%) in the drain group needed reoperation or percutaneous drainage by postoperative day 30 vs 29 (15%) in the no drain group, favoring the drain group (difference, 7.2%; 90% CI, 2.1-12.4; P = .02). Of note, the difference in the primary composite end point was entirely due to a similar difference in reoperation (5.1% in the drain group vs 12.4% in the no drain group; P = .01). Drain-related complications occurred in 4 patients.

CONCLUSIONS AND RELEVANCE: The findings of this study indicate that refraining from prophylactic drain use after gastrectomy heightened the risk of postoperative invasive procedures, discouraging its avoidance. Future studies identifying high-risk groups could optimize prophylactic drainage decisions.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04227951.

PMID:39602143 | DOI:10.1001/jamasurg.2024.5227

JAMA Dermatol. 2024 Nov 27. doi: 10.1001/jamadermatol.2024.4796. Online ahead of print.

ABSTRACT

IMPORTANCE: Prurigo nodularis (PN) is a chronic and debilitating skin condition, characterized by intense itch with multiple nodular lesions. Nemolizumab demonstrated significant improvements in itch and skin nodules in adults with moderate to severe PN in a previous 16-week phase 3 study (OLYMPIA 2).

OBJECTIVE: To assess the efficacy and occurrence of adverse events in adults with moderate to severe PN treated with nemolizumab vs those receiving placebo.

DESIGN, SETTING, AND PARTICIPANTS: OLYMPIA 1 was a multicenter, placebo-controlled, phase 3 randomized clinical trial, conducted from August 2020 to March 2023 at 77 centers across 10 countries in adults with moderate to severe PN (at least 20 nodules and an Investigator’s Global Assessment [IGA] score ≥3) and Peak Pruritus Numerical Rating Scale (PP-NRS) score of at least 7.0; consisted of screening (up to 4 weeks), 24-week treatment, and 8-week follow-up periods.

INTERVENTIONS: Patients were randomized (2:1) to nemolizumab monotherapy, 30 mg or 60 mg (depending on baseline weight of less than 90 kg vs 90 kg or greater, respectively), or matching placebo administered every 4 weeks for 24 weeks.

MAIN OUTCOMES AND MEASURES: The primary end points were the proportion of patients with itch response (≥4-point improvement from baseline in weekly average PP-NRS) and IGA success (score of 0/1 [clear/almost clear] and 2-grade or more improvement from baseline) at week 16.

RESULTS: Of 286 patients (mean [SD] age, 57.5 [13.0] years; mean [SD] body weight, 85.0 [20.7] kg; 166 [58.0%] female), 190 were randomized to receive nemolizumab, and 96 were randomized to placebo. A significantly greater proportion of patients assigned to nemolizumab vs placebo achieved itch response (111/190 [58.4%] vs 16/96 [16.7%]; Δ, 40.1% [95% CI, 29.4%-50.8%]; P < .001) and IGA success (50/190 [26.3%] vs 7/96 [7.3%]; Δ, 14.6% [95% CI, 6.7%-22.6%]; P = .003) at week 16. At week 24, the proportion of patients with itch response was 58.3% vs 20.4% (Δ, 38.7% [95% CI, 27.5%-49.9%]) in the ad hoc analysis, and IGA success was 58/190 (30.5%) vs 9/96 (9.4%) (Δ, 19.2% [95% CI, 10.3%-28.1%]) in the nemolizumab-treated vs placebo group. During the treatment period, 134 patients (71.7%) receiving nemolizumab vs 62 patients (65.3%) receiving placebo had at least 1 adverse event; most events were of mild to moderate severity.

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, nemolizumab monotherapy led to clinically meaningful and statistically significant improvements in core signs and symptoms of PN.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04501666.

PMID:39602139 | DOI:10.1001/jamadermatol.2024.4796

Plant J. 2024 Nov 27. doi: 10.1111/tpj.17164. Online ahead of print.

ABSTRACT

Cannabis sativa L., known for its medicinal and psychoactive properties, has recently experienced rapid market expansion but remains understudied in terms of its fundamental biology due to historical prohibitions. This pioneering study implements GS and ML to optimize cannabinoid profiles in cannabis breeding. We analyzed a representative population of drug-type cannabis accessions, quantifying major cannabinoids and utilizing high-density genotyping with 250K SNPs for GS. Our evaluations of various models-including ML algorithms, statistical methods, and Bayesian approaches-highlighted Random Forest’s superior predictive accuracy for single and multi-trait genomic predictions, particularly for THC, CBD, and their precursors. Multi-trait analyses elucidated complex genetic interdependencies and identified key loci crucial to cannabinoid biosynthesis. These results demonstrate the efficacy of integrating GS and ML in developing cannabis varieties with tailored cannabinoid profiles.

PMID:39602132 | DOI:10.1111/tpj.17164

JAMA Dermatol. 2024 Nov 27. doi: 10.1001/jamadermatol.2024.4832. Online ahead of print.

NO ABSTRACT

PMID:39602129 | DOI:10.1001/jamadermatol.2024.4832

JAMA Netw Open. 2024 Nov 4;7(11):e2446684. doi: 10.1001/jamanetworkopen.2024.46684.

ABSTRACT

IMPORTANCE: Heart failure (HF) hospitalization is a common end point in HF trials; however, how HF hospitalization is associated with all-cause hospitalization in terms of proportionality, correlation of treatment effects, and concomitant reporting has not been studied.

OBJECTIVE: To determine the ratio of HF to all-cause hospitalizations, whether reported treatment effects on HF hospitalization are associated with treatment effects on all-cause hospitalization, and how often all-cause hospitalization is reported alongside HF hospitalization.

DATA SOURCES: PubMed was searched from inception to September 2, 2024, for randomized clinical trials (RCTs) of HF treatments using MeSH (medical subject heading) terms and keywords associated with heart failure, ventricular failure, ventricular dysfunction, and cardiac failure, as well as the names of specific journals.

STUDY SELECTION: RCTs of HF treatments and reporting on HF hospitalization published in 1 of 3 leading medical journals (New England Journal of Medicine, The Lancet, or JAMA).

DATA EXTRACTION AND SYNTHESIS: The PRISMA guidelines were followed. Data extraction was performed by 2 reviewers, and disagreements were resolved by consensus. Trial baseline characteristics and outcome data on HF and all-cause hospitalizations were extracted. The ratio of HF to all-cause hospitalizations was calculated. The association of HF hospitalization effects with all-cause hospitalization effects was evaluated using hierarchical bayesian models with weak priors. The posterior distribution was used to calculate the HF hospitalization treatment effects that would need to be observed before a high probability (97.5%) of a reduction in all-cause hospitalization could be achieved. The proportion of trials reporting all-cause hospitalization was calculated.

MAIN OUTCOMES AND MEASURES: HF and all-cause hospitalizations.

RESULTS: Of 113 trials enrolling 261 068 patients (median proportion of female participants, 25.4% [IQR, 21.3%-34.2%]; median age, 66.2 [IQR, 62.8-70.0] years), 60 (53.1%) reported on all-cause hospitalization. The weighted median ratio of HF to all-cause hospitalizations was 45.9% (IQR, 30.7%-51.7%). This ratio was higher in trials with greater proportions of New York Heart Association class III or IV HF, with lower left ventricular ejection fractions, investigating nonpharmaceutical interventions, and that restricted recruitment to patients with HF and reduced ejection fraction. Reported effects on HF and all-cause hospitalizations were well-correlated (R2 = 90.1%; 95% credible interval, 62.3%-99.8%). In a large trial, the intervention would have to decrease the odds of HF hospitalization by 16% to ensure any reduction, 36% to ensure a 10% reduction, and 56% to ensure a 20% reduction in the odds of all-cause hospitalization with 97.5% probability.

CONCLUSIONS AND RELEVANCE: In this meta-analysis of HF trials, all-cause hospitalization was underreported despite a large burden of non-HF hospitalizations. Large reductions in HF hospitalization must be observed before clinically relevant reductions in all-cause hospitalization can be inferred.

PMID:39602122 | DOI:10.1001/jamanetworkopen.2024.46684

JAMA Netw Open. 2024 Nov 4;7(11):e2447102. doi: 10.1001/jamanetworkopen.2024.47102.

ABSTRACT

IMPORTANCE: Individuals with type 2 diabetes (T2D) have high rates of mortality following myocardial infarction (MI). Hospitalization is an opportunity to initiate or continue evidence-based treatment to reduce risk in individuals with T2D and acute coronary syndrome (ACS).

OBJECTIVE: To determine patterns of evidence-based medication use during the period of transition from admission to discharge after hospitalization for MI or coronary revascularization among individuals with T2D and ACS.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used data from the Centers for Medicare & Medicaid Services (CMS) for January 1, 2018, to June 30, 2020. Medicare beneficiaries older than 18 years with T2D with a qualifying hospitalization were included. Individuals were followed before admission (90 days prior), at discharge (≤90 days), and after discharge (91-180 days after) from a hospitalization for MI or coronary revascularization. Data analysis was performed in June 2023.

EXPOSURES: Demographic data (race, sex, rural vs urban location of care, and comorbidities) were abstracted from CMS data using Master Beneficiary and Summary Files and International Statistical Classification of Diseases, Tenth Revision codes.

MAIN OUTCOME AND MEASURES: Medicare Part D prescription fill records were examined for the following agents: (1) angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), or angiotensin receptor-neprilysin inhibitors (ARNIs); (2) β-blockers; (3) platelet adenosine diphosphate receptor inhibitors (P2Y12Is); (4) statins or proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9Is); and (5) glucagon-like peptide 1 receptor agonists (GLP-1RAs) or sodium glucose cotransporter 2 inhibitors (SGLT2Is). Logistic regression analysis was used to examine the association between covariates and lack of prescription fills in the postdischarge period.

RESULTS: A total of 188 651 eligible Medicare beneficiaries with T2D and hospitalization for MI or coronary revascularization were identified. Their median age was 73.0 (IQR, 67.0-79.0) years, and more than half (111 982 [59.4%]) were men; 18 383 (9.7%) were Black and 153 461 (81.3%) were White. Not filling a cardiovascular medication after hospitalization was associated with not filling that medication at the time of discharge (adjusted risk ratio, 0.27 [95% CI, 0.27-0.28] for ACEIs, ARBs, or ARNIs; 0.24 [0.24-0.25] for β-blockers; 0.20 [0.19-0.20] for P2Y12Is; 0.31 [0.31-0.32] for statins or PCSK9Is; and 0.27 [0.26-0.28] for SGLT2Is or GLP-1RAs).

CONCLUSIONS AND RELEVANCE: In this cohort study of Medicare beneficiaries with T2D, longer-term medication use following hospitalization for MI was associated with medication use at the time of discharge. These findings highlight the critical importance of this period to optimize preventive care for these high-risk individuals. Further implementation science research is needed to develop strategies to improve use of these evidence-based medications.

PMID:39602121 | DOI:10.1001/jamanetworkopen.2024.47102

JAMA Netw Open. 2024 Nov 4;7(11):e2447530. doi: 10.1001/jamanetworkopen.2024.47530.

ABSTRACT

IMPORTANCE: There is a need for biomarkers that predict late recurrence risk and extended endocrine therapy (EET) benefit among patients with early-stage breast cancer (EBC). MammaPrint, a 70-gene expression risk-of-recurrence assay, has been found to project significant EET benefit in patients with assay-classified low-risk tumors.

OBJECTIVE: To determine the test’s utility in identifying which patients with EBC in the IDEAL (Investigation on the Duration of Extended Adjuvant Letrozole) trial could benefit from 5-year vs 2.5-year letrozole treatment.

DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of the IDEAL randomized clinical trial evaluated postmenopausal women with hormone receptor-positive EBC who were assigned to either 2.5 or 5 years of EET, with 10 years of follow-up after randomization. A 70-gene assay was used to classify tumors as high, low, or ultralow risk. Adverse event (AE) frequency and treatment compliance were evaluated. Statistical analyses were performed from April 2022 to September 2024.

INTERVENTIONS: After 5 years of endocrine therapy, patients were randomized to 2.5 or 5 years of EET with letrozole.

MAIN OUTCOMES AND MEASURES: Primary end point was distant recurrence (DR). Cox proportional hazard regression models and likelihood ratios tested the interaction between treatment and gene expression assay.

RESULTS: Among 515 women included (mean [SD] age at randomization, 59.9 [9.5] years), 265 were in the 2.5-year treatment arm and 250 in the 5-year treatment arm. Of these patients, 223 (43.3%) patients with 70-gene assay-classified low-risk tumors had a significant absolute benefit of 10.1% for DR (hazard ratio, 0.32; 95% CI, 0.12-0.87; P = .03). Treatment interaction was not significant for DR. Of patients with either 70-gene assay-classified high-risk tumors (259 [50.3%]) or ultralow risk tumors (33 [6.4%]), 5 years vs 2.5 years of EET was not associated with improved benefit for DR. As expected, rates of AEs and treatment discontinuation were comparable among the different 70-gene assay risk groups in each treatment arm.

CONCLUSIONS AND RELEVANCE: This secondary analysis of the IDEAL trial found that the 70-gene assay identified patients with low-risk tumors who could benefit from 5-year vs 2.5-year EET. These findings suggest that this gene expression assay could go beyond guiding neoadjuvant and adjuvant chemotherapy decisions to informing the optimal duration of adjuvant endocrine therapy.

TRIAL REGISTRATION: EU Clinical Trials Register Eudra CT: 2006-003958-16.

PMID:39602119 | DOI:10.1001/jamanetworkopen.2024.47530