Category: Statistics

JAMA Netw Open. 2025 Feb 3;8(2):e2461031. doi: 10.1001/jamanetworkopen.2024.61031.

ABSTRACT

IMPORTANCE: Adherence to the Mediterranean Diet (MedDiet) has been associated with a lower incidence of cancer and reduced weight gain. These associations suggest a potential role for the MedDiet in lowering the risk of obesity-related cancers (ORCs). Obesity is a known risk factor for various cancers and shows an inverse association with MedDiet adherence.

OBJECTIVE: To examine the association between adherence to the MedDiet and the risk of ORCs, considering the possible mediating role of adiposity.

DESIGN, SETTING, AND PARTICIPANTS: This prospective cohort study analyzed data from the European Prospective Investigation Into Cancer and Nutrition (EPIC) study, which enrolled participants aged 35 to 70 years from 1992 to 2000 across 23 centers in 10 countries. The data analysis was conducted from March 1 to May 31, 2023.

EXPOSURES: Dietary intake before baseline was evaluated using country-specific, validated questionnaires administered at recruitment. Adherence to the MedDiet was scored on a 9-point scale and categorized as low (0-3 points), medium (4-6 points), or high (7-9 points).

MAIN OUTCOMES AND MEASURES: The primary outcome was the incidence of ORCs, classified according to the 2015 International Agency for Research on Cancer criteria. Multivariable Cox proportional hazards regression models were used to assess the association between MedDiet adherence and ORC incidence. Mediation analyses were conducted to evaluate the role of waist to hip ratio and body mass index in this association.

RESULTS: A total of 450 111 participants were included in the study (mean [SD] age, 51.1 [9.8] years; 70.8% women) and followed up during a median (IQR) time of 14.9 (4.1) years. Among participants, 4.9% experienced an ORC (rates, 0.053, 0.049, and 0.043 per person-year in the low, medium, and high MedDiet adherence groups, respectively). Participants with high adherence to the MedDiet (7-9 points) had a lower risk of ORC compared with those with low adherence (0-3 points) (hazard ratio [HR], 0.94; 95% CI, 0.90-0.98). A similar inverse association was observed for participants with medium adherence (4-6 points vs 0-3 points). However, mediation analyses did not show associations of waist to hip ratio or body mass index between MedDiet adherence and ORC risk.

CONCLUSIONS AND RELEVANCE: These findings indicate that higher adherence to the MedDiet is associated with a modest reduction in the risk of ORCs, independent of adiposity measures. Further research is needed to clarify the mechanisms by which the MedDiet may contribute to cancer prevention.

PMID:39998833 | DOI:10.1001/jamanetworkopen.2024.61031

JAMA Netw Open. 2025 Feb 3;8(2):e2461559. doi: 10.1001/jamanetworkopen.2024.61559.

ABSTRACT

IMPORTANCE: The Veterans Health Administration (VHA) implemented the Comprehensive Suicide Risk Evaluation (CSRE) in 2019 to standardize suicide risk assessment across the health care system. Identifying CSRE responses associated with suicide could inform risk management and prevent suicide.

OBJECTIVE: To identify CSRE responses associated with subsequent suicide.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study examines acute (within 30 days) and chronic (within 365 days) suicide risk after 269 374 CSREs were administered. Participants included US VHA patients undergoing CSRE evaluation between November 1, 2019, and December 31, 2020. Data collection and analysis were performed from April 5 to August 20, 2024.

EXPOSURES: CSRE responses, including suicidal ideation, behaviors, warning signs, risk factors, and protective factors.

MAIN OUTCOME AND MEASURE: Suicide per death certificate data from the Department of Veterans Affairs and Department of Defense Mortality Data Repository. Outcomes were analyzed using multivariable Cox proportional hazards regression.

RESULTS: A total of 153 736 patients with 269 374 valid CSREs (86.26% male; mean [SD] age, 50.48 [15.26] years) were included in the multivariable-adjusted analyses of suicide. Suicidal ideation (hazard ratio [HR], 3.14; 95% CI, 1.51-6.54), firearm access (HR, 2.62; 95% CI, 1.49-4.61), making preparations for a suicide attempt (HR, 2.15; 95% CI, 1.27-3.62), seeking access to lethal means (HR, 2.04; 95% CI, 1.11-3.75), anxiety (HR, 1.80; 95% CI, 1.16-2.81), and psychiatric hospitalization history (HR, 1.63; 95% CI, 1.02-2.61) were associated with increased suicide risk within 30 days, whereas anger (HR, 0.50; 95% CI, 0.30-0.85) was associated with decreased risk. Suicidal ideation (HR, 1.63; 95% CI, 1.20-2.21), firearm access (HR, 1.55; 95% CI, 1.13-2.13), making preparations for a suicide attempt (HR, 1.56; 95% CI, 1.09-2.23), reckless behaviors (HR, 1.40; 95% CI, 1.00-1.95), and history of psychiatric hospitalization (HR, 1.68; 95% CI, 1.32-2.13) were associated with increased suicide risk within 365 days, whereas anger (HR, 0.56; 95% CI, 0.44-0.71), preexisting risk factors (eg, trauma; HR, 0.77; 95% CI, 0.62-0.96), and recent transition from the military (HR, 0.39; 95% CI, 0.22-0.70) were associated with decreased risk in multivariable-adjusted analyses. Suicide risk within 365 days was elevated among patients identified by clinicians to be at intermediate acute risk (HR, 1.39; 95% CI, 1.13-1.71), intermediate chronic risk (HR, 1.34; 95% CI, 1.01-1.77), and high chronic risk (HR, 1.74; 95% CI, 1.22-2.47) of suicide compared with patients at low risk in multivariable-adjusted analyses.

CONCLUSIONS AND RELEVANCE: In this cohort study of suicide following risk assessments, findings suggest that only a few constructs are associated with subsequent suicide, particularly suicidal ideation, firearm access, and preparatory behaviors. Developing risk prediction algorithms including CSRE responses may enhance clinical evaluation.

PMID:39998832 | DOI:10.1001/jamanetworkopen.2024.61559

JAMA Netw Open. 2025 Feb 3;8(2):e2461735. doi: 10.1001/jamanetworkopen.2024.61735.

ABSTRACT

IMPORTANCE: Immunotherapies are the preferred frontline treatment for most hepatocellular carcinomas (HCCs), but only a small subset of patients attain complete responses to immunotherapies, resulting in an absence of radiographic apparent disease. The clinical importance of these complete responses is unclear, and whether clinical or molecular features may define HCCs that are exquisitely sensitive to immunotherapies is ambiguous.

OBJECTIVE: To describe the long-term survival outcomes of complete responders to immunotherapies, and to examine whether clinical and genomic characteristics are associated with complete response.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study includes a post hoc analysis of the IMbrave150 trial (which enrolled patients across 17 countries in North America, Europe, Asia, and Australia) and a multicenter cohort analysis of patients with advanced HCC treated with frontline immunotherapies across 3 institutions (2 in the US and 1 in Asia). Complete responders were defined as patients with a complete response according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or modified RECIST. Statistical analyses were conducted from January to May 2024.

MAIN OUTCOMES AND MEASURES: The main outcome was overall survival measured as the time from start of immunotherapy to the date of death. Kaplan-Meier curves were used to estimate progression-free and overall survival, and differences in survival outcomes were assessed using the log-rank test.

RESULTS: The analytical sample included 279 patients (mean [SD] age, 64.7 [11.1] years; 228 male patients [81.7%]) treated with atezolizumab and bevacizumab in the IMbrave150 trial and 194 patients (mean [SD] age, 64.3 [11.4] years; 155 male patients [78.7%]) with frontline anti-programmed cell death 1 ligand 1 (PD-1/L1) therapies in a multicenter patient cohort. Complete responders had high disease-free survival rates at 2 years in the IMbrave150 (58.0%; 95% CI, 36.2%-74.7%) and multicenter (87.4%; 95% CI, 58.2%-96.7%) cohorts. Overall survival rates at 2 years for complete responders were 81.1% (95% CI, 64.4%-90.5%) in the IMbrave150 cohort and 93.3% (95% CI, 61.2%-99.0%) in the multicenter cohort. Among complete responders who discontinued treatment for reasons other than disease progression after a median duration of treatment of 24 months, disease recurrence was rare. Molecular profiling of HCC among complete responders did not reveal unique genetic alterations in these patients. However, cancers with complete responses had higher PD-L1 protein expression in the immune cell compartment and lower circulating tumor DNA levels.

CONCLUSIONS AND RELEVANCE: In this post hoc trial and multicenter cohort analysis of patients with HCC treated with immunotherapy, complete responders demonstrated prolonged survival and durable disease control even after discontinuation of therapy. Biological features of complete responders were also distinct, and further evaluation of immune cell PD-L1 protein expression and circulating tumor DNA as potential biomarkers is warranted.

PMID:39998829 | DOI:10.1001/jamanetworkopen.2024.61735

JAMA Netw Open. 2025 Feb 3;8(2):e2461803. doi: 10.1001/jamanetworkopen.2024.61803.

ABSTRACT

IMPORTANCE: The patient portal has a growing role in health care. Many health systems have implemented shared access functionality in which patients may register a care partner with unique identity credentials to access their portal. Uptake of shared access has been limited.

OBJECTIVE: To examine the outcomes of a multisite demonstration involving organizational strategies associated with registration and use of patient portal shared access.

DESIGN, SETTING, AND PARTICIPANTS: This quality improvement study was conducted in diverse sites within 3 health systems in the US: (1) geriatric oncology, (2) geriatric medicine, and (3) primary care. Patients aged 65 years or older with 1 or more visits during the 12-month demonstration period (July 1, 2022, through July 1, 2023, for sites 1 and 2; site 3 was delayed 3 months) and care partners who used the portal accounts of patients meeting these criteria were included. The 6-month postdemonstration period (August 1, 2023, through January 1, 2024) was compared with the 6-month predemonstration period (January 1 through June 1, 2022).

EXPOSURES: Organizational strategies (brochures, webpages, tip sheets, and implementation toolkits created using a human-centered design) to encourage shared access registration and use.

MAIN OUTCOMES AND MEASURES: Portal registration and use (logins, laboratory results viewed, clinical notes viewed, visits scheduled) by type of access (patient and care partner) from electronic health record data were examined. Patient- and care partner-reported awareness and use of shared access were measured using a postdemonstration survey.

RESULTS: A total of 16 005 patients from the 3 sites met the inclusion criteria (84.8% younger than 85 years and 61.5% women). Most patients had an activated portal account (91.0%) and logged in at least once (84.8%) during the 24 months spanning the demonstration and pre- and postdemonstration periods. New portal registrations were stable, but nonsignificant for shared access (110 of 14 758 [0.7%] vs 91 of 14 016 [0.6%]) and significantly decreased for patient access (677 of 3158 [21.5%] vs 225 of 1520 [13.2%]). Use of shared access before vs after the demonstration increased for number of logins (mean [SD], 5.9 [11.4] vs 6.8 [14.1]), laboratory results viewed (mean [SD], 0.7 [2.7] vs 1.1 [3.7]), clinical notes viewed (mean [SD], 0.2 [1.1] vs 0.6 [3.2]), and visits scheduled (mean [SD], 0.8 [10.8] vs 1.0 [5.4]). Of the 91 care partners reporting portal use in the postdemonstration survey, 48 (52.7%) indicated primarily using patient credentials and 31 (34.1%) indicated primarily using their own credentials. Less than one-half of patients (721 of 1664 [43.3%]) stated being aware of shared access.

CONCLUSIONS AND RELEVANCE: These findings show no association of the multisite demonstration with increased new registrations for shared access and only modest increases in portal use among care partners of older adults. As portal use expands to encompass legal documentation, medical decision-making, and patient education, policies to support proper use of identity credentials are needed.

PMID:39998827 | DOI:10.1001/jamanetworkopen.2024.61803

Ir Med J. 2025 Jan 27;118(1):5.

ABSTRACT

AIM: This study aims to evaluate the impact of increased radiological access for General Practitioners (GPs) on healthcare workflows and patient care outcomes, with a focus on musculoskeletal (MSK) MRIs.

METHODS: A mixed methods approach was used for this study. GPs completed online questionnaires and semi-structured interviews were conducted with orthopaedic and radiology consultants. Doctors were asked to evaluate their experience working within the GP ‘direct access’ to radiology scheme.

RESULTS: Increased GP access to radiology had many positive benefits, including improved efficiencies in healthcare workflow. Of the GPs surveyed 44 (84.5%) found an increased patient satisfaction rate and 46 (88.5%) found improved efficiencies in patient outcomes. However, it may be contributing to downstream inefficiencies and affecting prioritization of more urgent imaging in the system. 52 GPs surveyed and 8 semi structured interviews with radiologist and orthopaedic consultants were analysed.

DISCUSSION: Increased GP access to radiology has led to many important benefits in the Irish healthcare system. There is potential for more efficient healthcare workflows, and improved patient outcomes, pending more appropriate referral pathways and further investment in infrastructure and training.

PMID:39998825

Medicine (Baltimore). 2025 Feb 21;104(8):e41615. doi: 10.1097/MD.0000000000041615.

ABSTRACT

BACKGROUND: Postoperative delirium (POD) in older adults is associated with high risk of morbidity and mortality. With limited treatment options, prevention is essential. Melatonin has been suggested to prevent delirium through regulating the sleep-wake cycle and serotonin metabolism, which has been shown to be disrupted in patients with POD. However, the evidence regarding the use of melatonin for POD prevention is limited and inconclusive.

METHODS: Our multicenter, 2-arm, parallel-group, feasibility randomized controlled trial evaluated the effect of melatonin on POD incidence after noncardiac surgery in patients >65 years (n = 120). Patients were randomized to 3 mg oral melatonin or placebo once preoperatively and for 7 days postoperatively. Patients were assessed twice daily for delirium and followed at 3 months postoperatively. Feasibility outcomes were recruitment rate, medication adherence, and proportion completing 3-month follow-up. Clinical outcomes were delirium incidence, sleep quality, institutional discharge, and cognitive status at 3 months.

RESULTS: Between September 2021 and June 2023, 85 patients were randomized (~1 patient/wk); of these, 92.9% adhered to study medications and 87.1% completed the 3-month follow-up. POD occurred in 9 patients with no statistical difference between the groups (melatonin group, n = 7; placebo group, n = 2; adjusted odds ratio: 1.12; 95% confidence interval: 0.006-150.1). There were no differences in any other clinical outcomes. Pandemic-related challenges, including interruption of surgeries and restrictions on research procedures impacted feasibility and the study was terminated early due to futility.

CONCLUSIONS: Based on our observations, a sample size of >1000 patients is required for a definitive trial to evaluate the role of melatonin in reducing the incidence of POD. Design changes need to be considered to address feasibility challenges and ongoing post-pandemic modifications to patient care.

PMID:39998812 | DOI:10.1097/MD.0000000000041615

Radiol Phys Technol. 2025 Feb 25. doi: 10.1007/s12194-025-00885-3. Online ahead of print.

ABSTRACT

Lead-based radiation shielding used usually in radiology departments is being replaced by non-lead shields due to concerns over toxicity, high weight, and the impossibility of applying it in the imaging field. New studies refer to the use of nanomaterials and lightweight polymer-based composites as an alternative that can solve the problems caused by lead shields. The study aims to develop a flexible composite shield for CT scan imaging and examine its effectiveness in reducing radiation exposure. This study involved the construction of 1 mm thick composite shields used in chest CT scan imaging. The first type consisted of 10% bismuth oxide, the second type consisted of 10% tungsten, the third type consisted of 5% bismuth oxide and 5% tungsten, and 90% of the rest of the structure of all shields was silicone. This study examined the morphological test, tensile strength test, attenuation efficiency, and image quality assessment of these shields. The radiation transmission coefficient for 10% bismuth, 10% tungsten and 5% bismuth-5%tungsten shields was obtained as 0.86, 0.80, and 0.83, respectively. Also, the noise increasing percentage for mentioned shields were 6, 4, and 6%, respectively, compared to the case without a shield. The study found that the 10% tungsten-90% silicone shield is the most effective in reducing radiation exposure due to its K-edge and attenuation coefficients. According to the noise assessment, using these shields does not significantly affect the quality of images.

PMID:39998795 | DOI:10.1007/s12194-025-00885-3

Curr Med Sci. 2025 Feb 25. doi: 10.1007/s11596-025-00024-4. Online ahead of print.

ABSTRACT

OBJECTIVE: This study aimed to investigate the association between insulin resistance and the risk of cardiovascular disease.

METHODS: A cross-sectional study including 2128 participants aged 40-79 years was conducted using data from the National Health and Nutrition Examination Survey from 1999 to 2018. The quantitative insulin sensitivity check index (QUICKI) and homeostasis model assessment of β-cell function (HOMA-β) were used as independent variables. The 10-year risk of a first hard atherosclerotic cardiovascular event was used as the dependent variable, with other potential confounding factors considered. Multivariate linear regression models and smooth curve fitting were used to assess the associations between insulin resistance and 10-year risk.

RESULTS: A total of 2128 patients, comprising 1191 men and 937 women, were included in our analysis. The regression analyses revealed a negative correlation between the QUICKI score and the 10-year risk of a first hard atherosclerotic cardiovascular event [β = – 8.85, CI (- 15.77, – 1.93)] after adjusting for age, race, body mass index, systolic blood pressure, diastolic blood pressure, hypertension treatment, smoking, diabetes, and low-density lipoprotein cholesterol. Conversely, an increase in HOMA-β was associated with 10-year risk [β = 6.84, CI (0.45, 13.23)]. Gender-specific subgroup analysis indicated that the QUICKI had a β value of 0.077 (0.046, 0.108) for men and 0.080 (0.061, 0.094) for women.

CONCLUSION: This study demonstrated that increased insulin resistance is linked to an increased risk of cardiovascular disease.

PMID:39998770 | DOI:10.1007/s11596-025-00024-4

J Med Syst. 2025 Feb 25;49(1):31. doi: 10.1007/s10916-025-02164-5.

ABSTRACT

When the hospital census is near-capacity, either from insufficient physical beds or nurse staffing, discharge delays can result in postanesthesia care unit (PACU) congestion that backs up the operating rooms. Hospital administrators often promote increasing morning discharges as mitigation. Before the COVID-19 pandemic, most hospitalized Florida patients were discharged after 3 PM, without change from 2010 through 2018. The current study extended the observation period through 2022 to determine if discharge pressure during the COVID-19 pandemic from persistent high census resulted in overall earlier hospital discharges. Results showed the percentages of patients discharged by 12 noon or 3 PM remained unchanged. Among 1,034,515 discharges at 197 hospitals during the last 2 quarters of 2022, most discharges (P < 0.0001 versus 50%) occurred after 3 PM. The pooled incidence of discharges by noon was 13.2%, while the estimate of the incidence inverse weighted by the hospitals’ counts of discharges was 13.3% (97.5% 12.6% to 14.1%). The corresponding pooled incidences of discharges by 3 PM was 42.5%, and 43.7% (97.5% confidence interval 42.3% to 45.2%). All 136,924 combinations of hospital and Medicare severity diagnosis-related groups were evaluated to examine why discharges did not occur earlier. Among the 1377 such combinations (1% of the total) with a significant change in median length of stay, 95% (1313) were decreases in lengths of stay. The implication is that the pandemic had no salutatory effect on earlier discharges. Therefore, post-anesthesia care unit managers should continue to plan for most hospital beds to be unavailable until late afternoon.

PMID:39998727 | DOI:10.1007/s10916-025-02164-5

J Robot Surg. 2025 Feb 25;19(1):81. doi: 10.1007/s11701-025-02252-1.

ABSTRACT

Ventral hernia repairs (VHR) are commonly performed surgical procedures in the United States, with over 300,000 cases treated annually. Robotic surgery has gained traction for its safety and efficacy in VHR, particularly with techniques such as myofascial release. However, the extensive dissection involved in these procedures may lead to postoperative complications like seromas and hematomas. This study aims to assess the effectiveness of Arista™, an FDA-approved hemostatic agent, in reducing these complications during robotic-assisted laparoscopic VHR involving mesh placement in the retrorectus space. This single-institution single-blind prospective randomized controlled trial involved 100 patients undergoing elective robotic-assisted laparoscopic VHR at a tertiary referral hernia center. Participants were randomized to receive either 5 g of Arista™ or standard of care intraoperatively, with no hemostat applied in the control group. All patients had drains placed in the retrorectus space. Primary outcomes included drain output on the first postoperative day (POD), total drain output, and duration of drain placement. Secondary outcomes included estimated blood loss (EBL), number of drains used, operative time, and length of stay (LOS). This study was funded by Becton, Dickinson and Company (BD). The mean total drain output was significantly higher in the Arista™ group (592.8 ml) compared to the control group (407.9 ml; p = 0.01), with a 39.6% increase noted. However, no significant difference in drain output on the first postoperative day or drain duration was observed. Secondary outcomes revealed no statistically significant differences in EBL, number of drains, operative time, or LOS between the groups. While the application of Arista™ during robotic-assisted laparoscopic VHR resulted in increased total drain output, it did not significantly affect other postoperative metrics, including LOS and complications. Further research is warranted to explore the potential benefits of Arista™ in specific patient populations and surgical contexts.

PMID:39998726 | DOI:10.1007/s11701-025-02252-1