Nevin Manimala

Ann Ital Chir. 2025 Sep 16;97(1):119-125. doi: 10.62713/aic.3938.

ABSTRACT

AIM: This study aimed both to compare the efficacy of intravenous (IV) ibuprofen with periprostatic nerve block (PPNB) in pain control during prostate biopsy procedures and to investigate factors influencing pain scores.

METHODS: A total of 128 patients were prospectively enrolled between June and December 2023 and randomized into two groups: IV ibuprofen was Group 1 (n = 64) and PPNB was Group 2 (n = 64). Pain levels were assessed using a Visual Analog Scale (VAS) at various stages of the procedure. Demographic and clinical data, including age, prostate specific antigen (PSA) levels, prostate volume, body mass index (BMI), histopathology results, and Prostate Imaging-Reporting and Data System (PI-RADS) scores, were recorded and correlated among themselves.

RESULTS: The mean ages (64.68 ± 5.87 vs 63.33 ± 7.26 years), and median PSA level was [13.00 (8.04-41.68) ng/mL vs 10.00 (6.73-23.80) ng/mL] of Group 1 and 2 were as indicated, (p = 0.267 and p = 0.053, respectively). There were no statistically significant differences between the two groups in terms of prostate volume, BMI, PI-RADS score, and benign-malignant pathology on biopsy (p > 0.05). The median VAS scores estimated during insertion of rectal probe [4 (2-5) vs 2 (0-3)], prostate biopsy needle [3 (2-4) vs 0 (0-1)], and overall median VAS scores [4 (3-4) vs 1 (0-2)] were lower in Group 2 than Group 1 (p < 0.001 for all stages). Correlation analyses revealed that PSA levels, and malignant pathology influenced the pain scores in Group 1 (r = 0.230, p = 0.024; r = 0.268, p = 0.032, respectively). Regression analysis demonstrated that PSA levels and malignant pathology affected the overall VAS scores in Group 1 (p = 0.024 and p = 0.019, respectively).

CONCLUSIONS: IV ibuprofen demonstrates promise as an easily applicable analgesic method for prostate biopsy, particularly for patients who are unwilling or unable to undergo PPNB. This study underscores the need for large-scale investigations to validate these findings.

CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov with identifier (NCT06737939).

PMID:41537216 | DOI:10.62713/aic.3938

Ann Ital Chir. 2026 Jan 10;97(1):36-62. doi: 10.62713/aic.4228.

ABSTRACT

AIM: Lentigo maligna (LM) is the commonest melanoma in situ variant and frequently arises on chronically sun-exposed facial skin, where subclinical radial spread and background actinic melanocytic atypia complicate both surgical clearance and histological interpretation. The aim of this study is to appraise contemporary surgical options for LM and their oncological outcomes, focusing on conventional wide local excision (WLE), Mohs micrographic surgery (MMS), Paraffin embedded margin-controlled (“slow Mohs”) techniques and staged excision (SE).

METHODS: A comprehensive search of PubMed and Web of Science (January 2015-January 2025) retrieved retrospective cohorts, systematic reviews and meta-analyses that detailed technique, margin policy and outcomes for LM or lentigo maligna melanoma (LMM). Forty-six studies met prespecified criteria and were synthesised qualitatively.

RESULTS: WLE remains the most widely performed procedure but showed the greatest heterogeneity in practice. Initial clinical margins of 5 mm often required histological extensions to 7-12 mm to secure clearance; under WLE, residual disease rates reached 16.7% and recurrences ranged from 5.7% to 27.3%. In contrast, MMS, especially when using immunohistochemistry, achieved recurrence rates between 0-3% with ≥5 years of follow-up. Slow Mohs and staged excision provided intermediate recurrence control (0-5.7%) while preserving tissue but were limited by procedural variability and delayed reconstruction. Although one retrospective study reported improved disease-specific survival with MMS, most studies showed no significant differences in melanoma-specific or overall survival across surgical techniques. Limited long-term follow-up and inconsistent statistical reporting (e.g., confidence intervals) were common.

CONCLUSIONS: Margin-controlled approaches (MMS, slow Mohs, SE) afford superior local control to WLE and are preferable for lesions on cosmetically or functionally critical sites. Because survival appears equivalent, the choice of technique should be guided by anatomical location, lesion size, available expertise, patient characteristics and preferences as well as cost-effectiveness and available resources. Well-designed prospective trials with standardised protocols are essential to refine margin recommendations and compare long-term outcomes.

PMID:41537210 | DOI:10.62713/aic.4228

Ann Ital Chir. 2026 Jan 10;97(1):84-93. doi: 10.62713/aic.4374.

ABSTRACT

AIM: This study aimed to compare the efficacy and safety of ultrasound-guided percutaneous balloon dilatational tracheotomy (US-PDT) versus surgical tracheotomy (ST) in patients with acute respiratory failure (ARF).

METHODS: In this retrospective cohort study, 278 patients with ARF were enrolled from January 2022 to January 2025. These patients were divided into the US-PDT group (n = 135) and the ST group (n = 143) based on the surgical method used. Perioperative indicators, procedural success rates, inflammatory markers, hospitalization outcomes, and complications were systematically compared between the two groups.

RESULTS: The US-PDT group demonstrated superior outcomes across all measures. It was associated with a significantly shorter procedure time, smaller incision length, reduced intraoperative blood loss, and shorter duration of mechanical ventilation (all p < 0.001). The US-PDT group also showed a higher single-attempt procedural success rate, alongside a lower accidental extubation rate (all p < 0.001). Postoperative inflammatory markers (erythrocyte sedimentation rate [ESR], C-reactive protein [CRP], and procalcitonin [PCT]) were significantly lower in the US-PDT group (p < 0.001). Furthermore, the US-PDT group experienced reduced ventilator-associated pneumonia (VAP) incidence, higher weaning success, shorter intensive care unit (ICU) and hospital stays, and lower ICU and overall mortality (all p < 0.05). Complication rates were also significantly lower in the US-PDT group (p < 0.05).

CONCLUSIONS: US-PDT is a more efficient, safer, and less invasive alternative to ST for ARF patients, resulting in better clinical outcomes, reduced inflammation, fewer complications, and improved survival rates.

PMID:41537207 | DOI:10.62713/aic.4374

JAMA Netw Open. 2026 Jan 2;9(1):e2553803. doi: 10.1001/jamanetworkopen.2025.53803.

NO ABSTRACT

PMID:41533381 | DOI:10.1001/jamanetworkopen.2025.53803

JAMA Netw Open. 2026 Jan 2;9(1):e2551807. doi: 10.1001/jamanetworkopen.2025.51807.

ABSTRACT

IMPORTANCE: More than 30 million people in the US take prescribed benzodiazepines, which, when taken long-term, carry risks of falls, cognitive decline, and dependence. A previous trial showed that a patient-focused self-management intervention (Eliminating Medications Through Patient Ownership of End Results; EMPOWER) can reduce long-term benzodiazepine dependence use and the risks that accompany it.

OBJECTIVE: To replicate the finding of the EMPOWER trial after converting the intervention from printed materials to electronic format.

DESIGN, SETTING, AND PARTICIPANTS: This 2-arm, individually randomized clinical trial with a 6-month follow-up was conducted at US Veterans Health Administration primary care clinics in 2 Veterans Affairs health care systems. Participants included 161 primary care patients taking benzodiazepines for 3 or more months and having access to a smartphone, tablet, or desktop computer. Recruitment occurred from June 1, 2022, to January 31, 2024.

INTERVENTION: Participants were randomized to either the electronically delivered EMPOWER (EMPOWER-ED) protocol or asked to continue to follow clinician recommendations regarding their benzodiazepine use (treatment as usual).

MAIN OUTCOMES AND MEASURES: Preregistered primary outcomes were complete benzodiazepine cessation and at least 25% dose reduction at 6-month follow-up, assessed using pharmacy data. Secondary outcomes were self-reported anxiety symptoms, sleep quality, and overall health and quality of life. Analysis was performed on an intent-to-treat basis.

RESULTS: The 161 participants had a mean (SD) age of 61.9 (13.7) years and were mostly male (134 [83.2%]). Individuals assigned to the EMPOWER-ED group had a significantly greater likelihood of complete benzodiazepine cessation (odds ratio [OR], 5.31 [95% CI, 1.12-25.12]). There was no likelihood of at least a 25% dose reduction in the EMPOWER-ED group relative to the control group (OR, 2.51 [95% CI, 0.91-6.90]). No statistically significant difference was found between the 2 groups for the secondary outcomes.

CONCLUSIONS AND RELEVANCE: This randomized clinical trial found a large effect of a low-cost, self-administered electronic intervention for reducing benzodiazepine use among long-term users. Findings from this replicated clinical trial are encouraging given the prevalence of benzodiazepine dependence and the constraints on clinician time available to address it. Dissemination of this intervention-which is in the public domain-by health care and public health systems seems warranted.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04572750.

PMID:41533380 | DOI:10.1001/jamanetworkopen.2025.51807

JAMA Netw Open. 2026 Jan 2;9(1):e2552518. doi: 10.1001/jamanetworkopen.2025.52518.

ABSTRACT

IMPORTANCE: Lyme disease (LD) is the most common vector-borne illness in the US. Given the increasing prevalence and expanding geographic bounds of LD, in-depth, up-to-date understanding of costs associated with an LD diagnosis, including patient out-of-pocket (OOP) costs, is needed.

OBJECTIVE: To assess health care costs in a broad US population diagnosed with LD, overall and stratified by localized disease vs disseminated disease.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study identified patients from Optum’s deidentified Market Clarity Data (Optum Market Clarity) between December 2, 2014, and January 30, 2023 (study period), with an LD diagnosis between January 1, 2016, and December 31, 2022 (identification period), having at least 14 months of continuous health plan enrollment. Optum Market Clarity is an integrated, multisource medical claims, pharmacy claims, and electronic health records data set. Outpatients had a claim with an LD diagnosis plus relevant antibiotics within 30 days, and inpatients had a claim with LD as the primary diagnosis or as a secondary diagnosis with an LD-associated condition as the primary diagnosis. Data were analyzed from February 27, 2023, to October 20, 2025.

EXPOSURE: The main exposure was LD diagnosis. Case patients were classified as having disseminated, localized, or indeterminate LD based on diagnosis codes for LD and LD-associated conditions, inpatient vs outpatient services, or antibiotic treatment type.

MAIN OUTCOMES AND MEASURES: Health care costs (reported in US dollars) for LD cases overall and stratified by localized disease vs disseminated disease were assessed 4 ways: (1) LD-specific costs per episode, (2) all-cause 6-month baseline vs follow-up costs for case patients with LD, (3) all-cause 6-month follow-up costs for case patients with LD compared with the control group, and (4) multivariable case-control analysis. Costs are reported as estimated direct (standardized) costs and patient OOP costs. Wald 95% CIs were used for means of cost measures.

RESULTS: A total of 70 531 case patients with LD were included. Their mean (SD) age was 44.8 (21.3) years; 51.3% were female. Estimated direct costs of LD were substantial across assessment methods, including episode cost (mean, $2227 [95% CI, $2111-$2342]), case patients as self-controls analysis (difference, $3304 [95% CI, $3117-$3491] in mean 6-month costs between baseline and follow-up), case-control analysis (difference, $4098 [95% CI, $3888-$4307] in mean 6-month follow-up costs), and multivariable-adjusted analysis (case-control difference, $5571 in projected mean 6-month follow-up costs; cost ratio, 1.96 [95% CI, 1.90-2.02]). OOP costs were available for 10 962 patients (15.5%) with LD. Mean OOP costs attributed to LD ranged from $188 to $399. Extrapolating to the US population in high-incidence states, annual costs of LD could range between $591 million and $1.05 billion (2022 dollars), with $411 to $771 million attributable to disseminated disease.

CONCLUSIONS AND RELEVANCE: In this retrospective cohort study, LD presented a large financial burden to the health care system and patients, especially for those with disseminated disease. These findings highlight the need for effective preventive measures to reduce costs for patients and the health care system.

PMID:41533379 | DOI:10.1001/jamanetworkopen.2025.52518

JAMA Netw Open. 2026 Jan 2;9(1):e2553965. doi: 10.1001/jamanetworkopen.2025.53965.

ABSTRACT

IMPORTANCE: Laboratory testing is necessary to distinguish blastomycosis, coccidioidomycosis, or histoplasmosis from other causes of community-acquired pneumonia (CAP). Robust data about testing for and diagnosis of these fungal diseases among patients with CAP throughout the US are lacking.

OBJECTIVE: To examine proportions and characteristics of (1) adult outpatients with CAP who underwent diagnostic testing for blastomycosis, coccidioidomycosis, or histoplasmosis; and (2) tested patients who received diagnoses of these diseases.

DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study used 2017 to 2023 commercial health insurance claims data from the Merative MarketScan Commercial/Medicare Database. Adult outpatients with diagnosis codes for unspecified CAP were included.

MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of patients who underwent fungal diagnostic testing. The secondary outcomes were the proportions of tested patients who received diagnoses of blastomycosis, coccidioidomycosis, or histoplasmosis. Multivariable logistic regression models were used to estimate adjusted odds ratios (aORs) for characteristics independently associated with receiving a diagnosis of coccidioidomycosis or histoplasmosis.

RESULTS: Among 573 994 patients (318 152 female [55%]; median [IQR] age, 54 [41-63] years) with unspecified CAP, 25 822 (5%) underwent fungal diagnostic testing, which occurred a median (IQR) of 3 (1-6) health care visits after the initial CAP diagnosis. Among tested patients, 755 (3%) received a blastomycosis, coccidioidomycosis, or histoplasmosis diagnosis code. Rash (aOR, 3.24; 95% CI, 2.27-4.63), lymphadenopathy (aOR, 1.74; 95% CI, 1.15-2.63), myalgia (aOR, 1.66; 95% CI, 1.11-2.49), chest pain (aOR, 1.65; 95% CI, 1.35-2.02), and receipt of antibiotics from multiple classes (aOR, 1.40; 95% CI, 1.17-1.67) were independently associated with increased odds of receiving a coccidioidomycosis diagnosis. Autoimmune inflammatory disease (aOR, 3.00; 95% CI, 1.72-5.21), chest pain (aOR, 1.84; 95% CI, 1.20-2.82), and abnormal weight loss (aOR, 5.15; 95% CI, 2.71-9.79) were associated with increased odds of receiving a histoplasmosis diagnosis.

CONCLUSIONS AND RELEVANCE: In this cohort study of patients with unspecified CAP, testing rates for blastomycosis, coccidioidomycosis, and histoplasmosis were low in many locations. Increased awareness of these fungal infections may help increase timely testing for fungal diseases among patients with CAP, decrease health care utilization and inappropriate antibiotic use, and improve patient outcomes.

PMID:41533376 | DOI:10.1001/jamanetworkopen.2025.53965

JAMA Netw Open. 2026 Jan 2;9(1):e2553974. doi: 10.1001/jamanetworkopen.2025.53974.

ABSTRACT

IMPORTANCE: Burnout is highly prevalent among resident physicians, producing serious personal, professional, and system consequences. While work hour restrictions were implemented to improve patient safety and resident fatigue, the relationship between work hours with burnout and well-being remains unclear.

OBJECTIVE: To evaluate the association of work hours with burnout, stress, and self-perceived competency among residents in high-burnout specialties, and to explore potential demographic and well-being-related moderators.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study included responses from a remote survey conducted from February to June 2024 as part of a randomized clinical trial evaluating a well-being intervention among resident physicians. Eligible participants were residents enrolled in high-burnout specialty residency programs (surgery, obstetrics-gynecology, family, internal, and emergency medicine) in the US.

EXPOSURE: Self-reported average weekly work hours and total hours worked in the past week.

MAIN OUTCOME AND MEASURES: Burnout, stress, and self-assessed Accreditation Council for Graduate Medical Education (ACGME) competency milestones, adjusting for demographics.

RESULTS: A total of 540 residents responded (356 cisgender women [66.8%]; 112 Asian [21.1%], 28 Black [5.3%], 355 White [67.0%]). The sample was predominantly in a medical specialty (56%). The mean (SD) number of average hours worked was 65.4 (11.3) and the mean (SD) number of hours worked in the last week was 60.1 (17.4). There was no significant association between burnout and average hours worked (β = 0.05 [95% CI, -0.05 to 0.15]; P = .34) or hours worked last week (β = 0.06 [95% CI, -0.03 to 0.15]; P = .21). However, stress was positively associated with average hours worked (β = 0.17 [95% CI, 0.07 to 0.26]; P = .001) and hours worked last week (β = 0.27 [95% CI, 0.18 to 0.36]; P < .001). Self-assessed ACGME competency milestones were also positively associated with average hours worked (β = 0.14 [95% CI, 0.07 to 0.21]; P < .001) and hours worked last week (β = 0.08 [95% CI, 0.01 to 0.15]; P = .02). Despite exploring a large set of candidate moderators, very few moderators were identified and none survived P value adjustment.

CONCLUSION AND RELEVANCE: In this cross-sectional nationwide study of resident physicians in high-burnout specialties, longer work hours were associated with higher stress and self-perceived competency, but not with burnout. This suggests that work hours alone may not explain high burnout levels in residency; a more comprehensive approach beyond work hour restrictions is needed to support resident well-being in training.

PMID:41533375 | DOI:10.1001/jamanetworkopen.2025.53974

JAMA Dermatol. 2026 Jan 14. doi: 10.1001/jamadermatol.2025.5295. Online ahead of print.

ABSTRACT

IMPORTANCE: ICP-332 is a tyrosine kinase 2 inhibitor currently under investigation for the treatment of atopic dermatitis (AD).

OBJECTIVE: To evaluate the safety and efficacy of ICP-332 for moderate to severe AD.

DESIGN, SETTING, AND PARTICIPANTS: This double-blind, placebo-controlled, phase 2 randomized clinical trial was conducted between February 6 and November 7, 2023, across 19 centers in China. Individuals aged 18 to 75 years who had diagnosis of AD for 1 year or longer and a history of contraindication or inadequate response to topical therapies were included.

INTERVENTION: Participants were randomized 1:1:1 to receive ICP-332 at 80 mg or 120 mg, or placebo orally once daily for 4 weeks. Study participants and personnel were blinded to group assignment.

MAIN OUTCOMES AND MEASURES: The primary outcome was safety. The key efficacy outcome was the percentage change from baseline in Eczema Area and Severity Index (EASI) at week 4. Other outcomes included percentages of patients achieving EASI-75 (a ≥75% improvement in EASI) and Validated Investigator Global Assessment for Atopic Dermatitis score of clear (0) or almost clear (1) with 2 or more points improvement.

RESULTS: This study included 75 patients (mean [SD] age, 37.3 [18.0] years in the ICP-332 groups and 44.5 [17.4] years in the placebo group; 21 women [28%] and 54 men [72%]). Among the 74 patients included in the safety set, 17 of 25 (68%) in the placebo group, 19 of 25 (76%) in the 80-mg ICP-332 group, and 18 of 24 (75%) in the 120-mg ICP-332 group experienced treatment-emergent adverse events, with all events being mild or moderate. The most common adverse event was decreased blood fibrinogen (1 of 25 [4%] in the placebo group, 6 of 25 [44%] in the 80-mg ICP-332 group, and 5 of 24 [21%] in the 120-mg ICP-332 group). Percentage reductions in EASI at week 4 were -78.2% (95% CI, -89.8% to -66.6%) in the 80-mg ICP-332 group, -72.5% (95% CI, -84.3% to -60.7%) in the 120-mg ICP-332 group, and -16.7% (95% CI, -28.7% to -4.6%) for those receiving placebo. Mean differences vs placebo for percentage reductions from baseline at week 4 in EASI were -61.6% (95% CI, -78.4% to -44.7%; P < .001) and -55.8% (95% CI, -72.8% to -38.9%; P < .001) for 80-mg ICP-332 and 120-mg ICP-332, respectively. There was a statistically significant higher EASI-75 response rate with both ICP-332 doses (64.0% for each; difference vs placebo, 56.0%; 95% CI, 34.4%-77.6%; P < .001) than with placebo and a greater percentage of Validated Investigator Global Assessment for Atopic Dermatitis score of 0 or 1 and improvement of 2 or more points at week 4 in the 80-mg ICP-332 group vs placebo (36.0%; difference vs placebo, 32.0%; 95% CI, 11.7%-52.3%; P = .005).

CONCLUSIONS AND RELEVANCE: In this phase 2 randomized clinical trial, ICP-332 demonstrated a favorable safety profile and encouraging efficacy, supporting further development for AD.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05702268.

PMID:41533373 | DOI:10.1001/jamadermatol.2025.5295