Categories
Nevin Manimala Statistics

Randomized Clinical Trials That Advance Health and Health Equity: JAMA Internal Medicine Call for Papers

JAMA Intern Med. 2024 Jul 15. doi: 10.1001/jamainternmed.2024.3149. Online ahead of print.

NO ABSTRACT

PMID:39008289 | DOI:10.1001/jamainternmed.2024.3149

Categories
Nevin Manimala Statistics

Mental Health of Transgender Youth Following Gender Identity Milestones by Level of Family Support

JAMA Pediatr. 2024 Jul 15. doi: 10.1001/jamapediatrics.2024.2035. Online ahead of print.

ABSTRACT

IMPORTANCE: Transgender youth are at an elevated risk for adverse mental health outcomes compared with their cisgender peers. Identifying opportunities for intervention is a priority.

OBJECTIVE: To estimate differences in the association between gender identity milestones and mental health outcomes among transgender youth, stratified by level of family support.

DESIGN, SETTINGS, AND PARTICIPANTS: This retrospective cohort study compares changes in mental health outcomes among transgender youth who initiate gender identity milestones compared with those who initiate the same milestones 1 year later, stratified by level of family support, using the 2015 US Transgender Survey. The analytic samples included 18 303 transgender adults aged 18 and older who had initiated at least 1 gender identity milestone between ages 4 and 18 years.

EXPOSURE: Four gender identity milestones: feeling one’s gender was different, thinking of oneself as transgender, telling another that one is transgender, and living full-time in one’s gender identity, stratified by 3 levels of family support: supportive, neutral, and adverse.

MAIN OUTCOMES: Age at first suicide attempt and at running away.

RESULTS: Study participants included 18 303 transgender adults (10 288 [56.2%] assigned female at birth; 14 777 [80.7%] White). Initiating a gender identity milestone was associated with a higher risk of suicide attempt and running away from home among transgender youth. This finding was driven by children who live in unsupportive families. For example, thinking of oneself as transgender was associated with a meaningful increase in the overall probability of attempting suicide among those in either adverse families (estimate = 1.75 percentage points; 95% CI, 0.47-3.03) or neutral families (estimate = 1.39 percentage points; 95% CI, 0.72-2.05). Among youth living with supportive families, there were no statistically significant associations between gender identity milestones and adverse mental health outcomes and 95% CIs generally ruled out any meaningful associations.

CONCLUSION: These results demonstrate that without a supportive family environment, gender identity development increases the risk of transgender youth attempting suicide or running away from home. Social services and community resources to establish supportive relationships between transgender children and their parents are essential.

PMID:39008285 | DOI:10.1001/jamapediatrics.2024.2035

Categories
Nevin Manimala Statistics

Exploring visuospatial function neuroplasticity in elite speed skaters: a resting-state fMRI independent component analysis

J Sports Med Phys Fitness. 2024 Jul 15. doi: 10.23736/S0022-4707.24.15947-6. Online ahead of print.

ABSTRACT

BACKGROUND: Limited research has been conducted on the neural mechanisms of visuospatial attention in closed skill sports. This research aimed to delve into the unique visuospatial attention abilities of skaters and elucidate the underlying neural mechanisms.

METHODS: This cross-sectional study employed an expert-novice paradigm, applying a purely data-driven approach to analyze and compare the resting-state networks (RSNs) associated with visuospatial attention in 15 elite skaters and 15 control subjects.

RESULTS: From the 38 components identified by independent component analysis (ICA) algorithm, five RSNs were selected, including the dorsal attention network (DAN), left and right fronto-parietal network (FPN), somatomotor network (SMN) and visual network (VIS). Elite skaters exhibited heightened functional connectivity (FC) in the right angular gyrus and left precuneus within DAN, left fusiform gyrus within left FPN, right primary motor cortex within right FPN, left supplementary motor area within SMN, and right primary visual cortex within VIS compared to the control group. Conversely, skaters demonstrated diminished FC in the bilateral superior temporal gyrus within DAN and right prefrontal cortex within the right FPN.

CONCLUSIONS: Statistical results demonstrated significant differences in RSNs related to visuospatial functions in a wide range of brain regions between elite skaters and controls. We further speculate that these variances could be attributable to alterations in visuospatial abilities resulting from years of devoted skating training. The findings of this study offer novel perspectives on the neural reorganization linked to motor training, contributing to an enriched comprehension of the neuroplasticity changes inherent in prolonged engagement in motor skill development.

PMID:39008282 | DOI:10.23736/S0022-4707.24.15947-6

Categories
Nevin Manimala Statistics

Tirzepatide Improved Health-Related Quality of Life Compared with Insulin Lispro in Basal Insulin-Treated Adults with Type 2 Diabetes and Inadequate Glycaemic Control: A Randomised Controlled Phase 3b Trial (SURPASS-6)

Diabetes Ther. 2024 Jul 15. doi: 10.1007/s13300-024-01620-8. Online ahead of print.

ABSTRACT

INTRODUCTION: Patients with type 2 diabetes (T2D) who require intensification of basal insulin therapy need treatment options that can improve their health-related quality of life (HRQoL) and translate into better outcomes. These analyses compared patient-reported outcomes (PROs) in patients with T2D receiving tirzepatide or insulin lispro.

METHODS: The randomised, open-label, multinational, phase 3b SURPASS-6 trial (NCT04537923) was conducted at 135 medical research centres and hospitals in 15 countries and compared two recommended treatment intensification strategies in people with T2D and inadequate glycaemic control on basal insulin: addition of once-weekly tirzepatide versus addition of prandial insulin lispro. Randomisation was stratified by country, baseline glycated haemoglobin level and metformin use. PROs were measured using the Short Form-36 Health Survey version 2 (SF-36v2) acute form (secondary outcome), EQ-5D-5L, Ability to Perform Physical Activities of Daily Living (APPADL) questionnaire and Impact of Weight on Self-Perceptions (IW-SP) questionnaire (tertiary/exploratory outcomes). PROs were compared for the tirzepatide-pooled dose group (5, 10 and 15 mg) and each tirzepatide dose group versus insulin lispro at 52 weeks using the modified intention-to-treat efficacy analysis set.

RESULTS: Between 19 October 2020 and 01 November 2022, 2267 people were assessed and 1428 participants with T2D were randomised. At 52 weeks, participants in the tirzepatide-pooled group had statistically significant improved scores across all SF-36v2 domains and both component summary scores compared with insulin lispro-treated participants (p < 0.05), with the largest differences observed in the general health, vitality and mental health domains. Statistically significant improved APPADL and IW-SP total scores, as well as EQ visual analogue scale and EQ-5D-5L index scores (after adjustment for baseline scores), were observed in tirzepatide-pooled participants compared with insulin lispro-treated participants.

CONCLUSIONS: In adult patients with T2D and inadequate glycaemic control with basal insulin, tirzepatide treatment was associated with greater improvements in HRQoL than prandial insulin therapy in addition to clinically significant improvements in glycaemic and body weight-related parameters.

PMID:39008236 | DOI:10.1007/s13300-024-01620-8

Categories
Nevin Manimala Statistics

Bridging the Gap: Comparing Patient-Clinician Views on Treatment Goals and Communication in the Management of Atopic Dermatitis Within the Asia-Pacific Region

Dermatol Ther (Heidelb). 2024 Jul 15. doi: 10.1007/s13555-024-01232-x. Online ahead of print.

ABSTRACT

INTRODUCTION: It remains unclear how patients with atopic dermatitis (AD) and clinicians perceive the level of patient-clinician communication and if there could be potential lapses. This cross-sectional study aims to compare perspectives between patients with AD and dermatologists regarding communication and treatment expectations in Asia.

METHODS: Moderate-to-severe patients with AD and practicing dermatologists were recruited from eight Asia-Pacific territories, including Mainland China, Hong Kong, India, Japan, Singapore, South Korea, Taiwan, and Thailand. Patients and dermatologists completed separate surveys designed to elicit their expectations regarding AD management, and their perceived level of patient-clinician communication. Patients were also asked about their treatment satisfaction and whether they prefer additional treatment beyond what was prescribed. Demographic information and responses were analyzed using descriptive statistics. The study was reviewed by the institutional review board in each territory, and all participants provided informed consent.

RESULTS: A total of 1103 patients and 271 dermatologists completed the surveys. Both patients and dermatologists were largely aligned in their top treatment goals in AD management. However, greater proportions of patients prioritized the prevention of exacerbation (78.0% versus 47.2%), minimization of treatment adverse effects (46.4% versus 9.1%), and improvement in mental health (16.0% versus 4.9%), compared with dermatologists. Although patient-clinician communication was observed to be generally good, 10.9% of patients reported dissatisfaction with communication in AD management. The majority of patients were either “very satisfied” or “satisfied” with their latest acute AD treatment, but 65.5% of patients still desired additional treatment.

CONCLUSIONS: This multinational study has provided insights on the perspectives of Asian patients and dermatologists in treatment goals, AD management, and communication. In general, both patients and dermatologists were aligned in treatment goals and there was satisfactory patient-clinician communication in most aspects. However, potential areas of improvement have been identified to further enhance patient-centered care.

PMID:39008225 | DOI:10.1007/s13555-024-01232-x

Categories
Nevin Manimala Statistics

Acknowledging acute kidney disease following ureteroscopy and laser lithotripsy: results from a tertiary care referral center

Int Urol Nephrol. 2024 Jul 15. doi: 10.1007/s11255-024-04155-w. Online ahead of print.

ABSTRACT

BACKGROUND: Acute kidney disease (AKD) is a recently described syndrome consisting of kidney function abnormalities lasting less than 3 months. Little is known regarding AKD following ureteroscopy (URS) and laser lithotripsy.

OBJECTIVE: To evaluate the occurrence and evolution of AKD in stone patients treated with URS.

MATERIALS AND METHODS: Data from 284 patients treated with URS for urinary stones were retrospectively analyzed. According to the KDIGO 2020 criteria, AKD was defined as postoperative acute kidney injury (AKI) occurrence, estimated glomerular filtration rate (eGFR) decrease ≥ 35%, or serum creatinine (SCr) increase ≥ 50%. AKI was defined as SCr increase ≥ 0.3 mg/dL or ≥ 50%. AKD evolution was evaluated 60 days post-URS. Data were analyzed using descriptive statistics. Univariable (UVA) and multivariable (MVA) logistic regression analyses tested the association of patients’ characteristics and perioperative data with the occurrence of AKD.

RESULTS: Overall, postoperative AKD occurred in 32 (11.3%) patients. Recovery from AKD was found in 26 (82%) patients and persistent AKD occurred in 6 (18%) patients. At UVA, age at surgery (p = 0.05), baseline SCr (p = 0.02), baseline CKD category (p = 0.006), Charlson comorbidity index (p = 0.01), operative time (p = 0.04) and postoperative complications (< 0.001) were associated with AKD. At MVA, CKD category (OR 2.99, 95% CI = 1.4-6.3; p = 0.004), operative time (OR 1.01, 95% CI = 1.001-1.018; p = 0.023) and postoperative complications (OR 3.5, 95% CI = 1.46-8.49; p = 0.005) were independent predictors of AKD.

CONCLUSIONS: AKD is a frequent complication in patients treated with URS. Moreover, AKD persists in a non-neglectable percentage of patients at medium-term follow-up. Therefore, nephrological assessment should be considered, especially in high-risk patients. Current findings should be considered for the peri-operative management of stone patients.

PMID:39008224 | DOI:10.1007/s11255-024-04155-w

Categories
Nevin Manimala Statistics

The association between non-high-density lipoprotein cholesterol to high-density lipoprotein cholesterol ratio (NHHR) and prevalence of urinary stones in US adults: a cross-sectional NHANES study

Int Urol Nephrol. 2024 Jul 15. doi: 10.1007/s11255-024-04140-3. Online ahead of print.

ABSTRACT

BACKGROUND: This study examines the association between the non-high-density lipoprotein cholesterol to high-density lipoprotein cholesterol ratio (NHHR) and urinary stones in American adults.

METHODS: We conducted a cross-sectional study utilizing the 2007-2018 National Health and Nutrition Examination Survey (NHANES) data set. The prevalence of urinary stones was determined based on patient-reported experiences of renal colic. We converted NHHR to natural logarithm (ln-NHHR) to align it better with our statistical analyses. Our analysis methods included weighted multivariate logistic regression, generalized additive model (GAM), and application of smoothed curves to better elucidate the association between ln-NHHR and the prevalence of urinary stones. In addition, we conducted subgroup analyses and employed multiple imputation for sensitivity analyses.

RESULTS: This study involved a total of 30,903 participants, with a 9.97% prevalence of urinary stones and reported colic experience. Elevated ln-NHHR levels were linked with a higher likelihood of urinary stones (OR = 1.20, 95% CI 1.07-1.35). Smooth curve fitting revealed an inverted U-shaped relationship, pinpointing a significant increase in urinary stone risk at ln-NHHR levels below 1.43 (OR = 1.40, 95% CI 1.19-1.64, p < 0.001). Notably, this correlation was stronger among Non-Hispanic Whites and those married or living with a partner. Multiple imputation analyses strengthened the confidence in our results.

CONCLUSIONS: Our findings suggest a reverse U-shaped association between urinary stone occurrence and NHHR level, with a positive association at ln-NHHR < 1.43. This correlation was more pronounced in the Non-Hispanic White population and among those married or living with a partner.

PMID:39008223 | DOI:10.1007/s11255-024-04140-3

Categories
Nevin Manimala Statistics

Psychometric evaluation of the Adherence to Refills and Medications Scale (ARMS) in Australians living with gout

Clin Rheumatol. 2024 Jul 15. doi: 10.1007/s10067-024-07050-y. Online ahead of print.

ABSTRACT

This study aimed to examine psychometric properties of the Adherence to Refills and Medications Scale (ARMS) in people with gout. We conducted exploratory factor analysis (EFA) and tested internal consistency (ordinal and Cronbach’s alpha coefficients) and agreement (intraclass correlation coefficient (2,1)) in ARMS scores across three timepoints (baseline, 6, and 12 months) in 487 people with gout. The Kruskal-Wallis test, Spearman’s rank, Kendall’s tau-b correlations, and logistic regression were used to examine the criterion-related validity of the ARMS and factors associated with the ARMS. EFA suggested a one-factor structure, explaining 43.2% of total variance. High internal consistency (ordinal alpha = 0.902 at baseline) and moderate agreement in ARMS scores over time (ICCs > 0.5; p < 0.001) were observed. Lower ARMS scores (indicating better adherence) predicted achieving target serum urate (OR, 0.89; 95% CI, 0.83-0.95; p < 0.001), but not urate-lowering therapy (ULT) adherence (Proportion of Days Covered (PDC) ≥ 80%) (OR, 0.93; 95% CI, 0.81-1.05; p = 0.261). Negative correlations between ARMS and PDC were not statistically significant (Kendall’s tau-b, r = – 0.126, p = 0.078; Spearman’s rho = – 0.173, p < 0.073). Differences in median ARMS scores (IQR) of 16 (14-20), 13 (12-15), and 17.5 (15-21) in three groups of participants who reported (1) not taking ULT, (2) taking ULT and adherent, and (3) taking ULT but not adherent, respectively, were statistically significant (p < 0.001). Age was the only patient factor independently associated with optimal adherence (ARMS score = 12) (OR, 1.91; 95% CI, 1.50-2.43; p < 0.001). The ARMS is a reliable and valid measure of medication adherence behaviours in people with gout, justifying its use in gout medication adherence research.

PMID:39008222 | DOI:10.1007/s10067-024-07050-y

Categories
Nevin Manimala Statistics

The relationship between Nuclear Factor-Kappa B and Inhibitor-Kappa B parameters with clinical course in COVID-19 patients

Mol Biol Rep. 2024 Jul 15;51(1):813. doi: 10.1007/s11033-024-09729-6.

ABSTRACT

BACKGROUND: We aimed to investigate the serum Nuclear Factor Kappa B (NF-κB) p105, NF-κB p65 and Inhibitor Kappa B Alpha (IκBα) levels in patients with mild/moderate Coronavirus Disease 2019 (COVID-19) and their association with the course of the disease.

MATERIALS AND METHODS: Blood was drawn from 35 COVID-19 patients who applied to the Department of Emergency Medicine of Istanbul University-Cerrahpasa at the time of diagnosis and from 35 healthy individuals. The patients were evaluated to have mild/moderate degree of disease according to National Early Warning Score 2 (NEWS2) scoring and computed tomography (CT) findings. The markers were studied in the obtained serum samples, using enzyme-linked immunoassay (ELISA). Receiver Operating Characteristic (ROC) analysis was performed. Statistical significance was evaluated to be p < 0.05.

RESULTS: NF-κB p105 levels were significantly higher in the COVID-19 group compared to the control group. C-reactive protein (CRP), D-dimer, ferritin levels of the patients were significantly higher (p < 0.001) compared to the control group, while the lymphocyte count was found lower (p = 0.001). IκBα and NF-κB p65 levels are similar in both groups. Threshold value for NF-κB p105 was above 0.78 ng/mL, sensitivity was 71.4% and specificity was 97.1% (p < 0.05). NF-κB p105 levels at the time of diagnosis of the patients who required supplemental oxygen (O2), were significantly higher (p < 0.01).

CONCLUSIONS: The rise in serum NF-κB p105 levels during the early stages of infection holds diagnostic value. Besides its relation with severity might have a prognostic feature to foresee the requirement for supplemental O2 that occurs during hospitalization.

PMID:39008220 | DOI:10.1007/s11033-024-09729-6

Categories
Nevin Manimala Statistics

Postoperative Adverse Events Following Neoadjuvant Therapy and Surgery for Borderline Resectable Pancreatic Cancer in a Phase 2 Clinical Trial (Alliance A021501)

Ann Surg Oncol. 2024 Jul 15. doi: 10.1245/s10434-024-15670-6. Online ahead of print.

ABSTRACT

BACKGROUND: Postoperative adverse events (AEs) in patients with borderline resectable pancreatic ductal adenocarcinoma (BR-PC) treated with neoadjuvant therapy and pancreatectomy in the national cooperative group setting have not been previously characterized. We conducted a preplanned secondary analysis of patients enrolled on the Alliance A021501 clinical trial to quantify perioperative AE rates.

METHODS: The A021501 phase 2 trial randomized patients with BR-PC to receive 8 doses of mFOLFIRINOX (Arm 1) or 7 doses of mFOLFIRINOX and hypofractionated radiotherapy (Arm 2), followed by pancreatectomy (December 31, 2016 to May 31, 2019). Adverse events were assessed 90 days after pancreatectomy.

RESULTS: Of 126 enrolled patients, 51 (40%) underwent pancreatectomy (n = 32, Arm 1; n = 19, Arm 2) at 28 institutions. Five (10%) patients required reoperation within 90 days; 56% of patients (n = 27/48) experienced at least one grade 3 or higher AE (50% vs. 67%, p = 0.37). Ninety-day mortality was 2.0%. Readmission was less frequent in Arm 1 (16% vs. 42%, p = 0.05), but there were no differences between study arms in rates of reoperation (13% vs. 5%), pancreatic fistula or intra-abdominal abscess requiring drainage (9% vs. 16%), or wound infection (6% vs. 16%). Pancreatic fistula or intra-abdominal abscess requiring drainage was associated with receipt of adjuvant therapy (p = 0.012). No difference in overall survival was observed based on occurrence of postoperative AEs (hazard ratio = 1.1; 95% confidence interval 0.5-2.6).

CONCLUSIONS: In this multicenter study, rates of postoperative AEs were consistent with those previously reported. Multimodality trials of preoperative therapy for BR-PC may be performed in the cooperative group setting with careful quality assurance and safety monitoring.

TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02839343.

PMID:39008208 | DOI:10.1245/s10434-024-15670-6