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Nevin Manimala Statistics

Influencing Factors on Pupillary Light Responses as a Biomarker for Local Retinal Function in a Large Normative Cohort

Invest Ophthalmol Vis Sci. 2024 Jun 3;65(6):3. doi: 10.1167/iovs.65.6.3.

ABSTRACT

PURPOSE: Investigating influencing factors on the pupillary light response (PLR) as a biomarker for local retinal function by providing epidemiological data of a large normative collective and to establish a normative database for the evaluation of chromatic pupil campimetry (CPC).

METHODS: Demographic and ophthalmologic characteristics were captured and PLR parameters of 150 healthy participants (94 women) aged 18 to 79 years (median = 46 years) were measured with L-cone- and rod-favoring CPC protocols. Linear-mixed effects models were performed to determine factors influencing the PLR and optical coherence tomography (OCT) data were correlated with the pupillary function volume.

RESULTS: Relative maximal constriction amplitude (relMCA) and latency under L-cone- and rod-favoring stimulation were statistically significantly affected by the stimulus eccentricity (P < 0.0001, respectively). Iris color and gender did not affect relMCA or latency significantly; visual hemifield, season, and daytime showed only minor influence under few stimulus conditions. Age had a statistically significant effect on latency under rod-specific stimulation with a latency prolongation ≥60 years. Under photopic and scotopic conditions, baseline pupil diameter declined significantly with increasing age (P < 0.0001, respectively). Pupillary function volume and OCT data were not correlated relevantly.

CONCLUSIONS: Stimulus eccentricity had the most relevant impact on relMCA and latency of the PLR during L-cone- and rod-favoring stimulation. Latency is prolonged ≥60 years under scotopic conditions. Considering the large study collective, a representative normative database for relMCA and latency as valid readout parameters for L-cone- and rod-favoring stimulation could be established. This further validates the usability of the PLR in CPC as a biomarker for local retinal function.

PMID:38829669 | DOI:10.1167/iovs.65.6.3

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The Integration of Clinical Trials With the Practice of Medicine: Repairing a House Divided

JAMA. 2024 Jun 3. doi: 10.1001/jama.2024.4088. Online ahead of print.

ABSTRACT

IMPORTANCE: Optimal health care delivery, both now and in the future, requires a continuous loop of knowledge generation, dissemination, and uptake on how best to provide care, not just determining what interventions work but also how best to ensure they are provided to those who need them. The randomized clinical trial (RCT) is the most rigorous instrument to determine what works in health care. However, major issues with both the clinical trials enterprise and the lack of integration of clinical trials with health care delivery compromise medicine’s ability to best serve society.

OBSERVATIONS: In most resource-rich countries, the clinical trials and health care delivery enterprises function as separate entities, with siloed goals, infrastructure, and incentives. Consequently, RCTs are often poorly relevant and responsive to the needs of patients and those responsible for care delivery. At the same time, health care delivery systems are often disengaged from clinical trials and fail to rapidly incorporate knowledge generated from RCTs into practice. Though longstanding, these issues are more pressing given the lessons learned from the COVID-19 pandemic, heightened awareness of the disproportionate impact of poor access to optimal care on vulnerable populations, and the unprecedented opportunity for improvement offered by the digital revolution in health care. Four major areas must be improved. First, especially in the US, greater clarity is required to ensure appropriate regulation and oversight of implementation science, quality improvement, embedded clinical trials, and learning health systems. Second, greater adoption is required of study designs that improve statistical and logistical efficiency and lower the burden on participants and clinicians, allowing trials to be smarter, safer, and faster. Third, RCTs could be considerably more responsive and efficient if they were better integrated with electronic health records. However, this advance first requires greater adoption of standards and processes designed to ensure health data are adequately reliable and accurate and capable of being transferred responsibly and efficiently across platforms and organizations. Fourth, tackling the problems described above requires alignment of stakeholders in the clinical trials and health care delivery enterprises through financial and nonfinancial incentives, which could be enabled by new legislation. Solutions exist for each of these problems, and there are examples of success for each, but there is a failure to implement at adequate scale.

CONCLUSIONS AND RELEVANCE: The gulf between current care and that which could be delivered has arguably never been wider. A key contributor is that the 2 limbs of knowledge generation and implementation-the clinical trials and health care delivery enterprises-operate as a house divided. Better integration of these 2 worlds is key to accelerated improvement in health care delivery.

PMID:38829654 | DOI:10.1001/jama.2024.4088

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The Effect of Night Shift on Blood Pressure in Healthcare Workers

Turk Kardiyol Dern Ars. 2024 Jun;52(4):269-273. doi: 10.5543/tkda.2024.55484.

ABSTRACT

OBJECTIVE: Individuals across all age groups may experience elevated blood pressure due to a combination of internal and environmental factors. Factors influencing arterial pressure include diet, stress, sleep patterns, and lifestyle. This study aims to investigate the susceptibility to high blood pressure among occupational groups working night shifts.

METHOD: The study included healthcare worker participants who had at least six night shifts per month. A control group consisted of participants performing the same roles during daytime. Participants with chronic diseases or those taking blood pressure-affecting medication were excluded. Holter recordings were made over a minimum of 48 hours, including both a free day and a work day.

RESULTS: The study involved 114 participants-55 in the study group and 59 in the control group. Statistically significant differences were noted between the groups in the daylight-night ratios of systolic and diastolic pressures, with P values of 0.006 and 0.005, respectively. The systolic daylight-night difference was -5.7 ± 5.5% in the study group and -9.0 ± 7.0% in the control group. The diastolic daylight-night difference was -7.9 ± 9.6% in the study group and -12.7 ± 8.2% in the control group.

CONCLUSION: Occupations with nighttime work schedules are often associated with non-dipping blood pressure patterns due to sleep disturbances. It is crucial to consider the blunted dipping of blood pressure induced by night shift work when assessing and monitoring hypertension and related medical conditions.

PMID:38829641 | DOI:10.5543/tkda.2024.55484

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The Impact of Sodium-Glucose Cotransporter-2 Inhibitors on Atrial Electromechanical Conduction Time

Turk Kardiyol Dern Ars. 2024 Jun;52(4):237-243. doi: 10.5543/tkda.2024.27546.

ABSTRACT

OBJECTIVE: This study aims to explore the impact of sodium-glucose cotransporter-2 (SGLT-2) inhibitors, a newer class of oral antidiabetic drugs, on atrial electromechanical delay (EMD) in patients with type 2 diabetes mellitus (DM). This is particularly relevant given the significantly higher incidence of atrial fibrillation (AF) in diabetic patients compared to the general population. Atrial electromechanical delay is recognized as an important factor influencing the development of atrial fibrillation.

METHODS: This study included 30 type 2 DM patients (53.3% female, mean age 60.07 ± 10.03 years), initiating treatment with SGLT-2 inhibitors. The patients were assessed using echocardiography at baseline and again at 6 months, focusing on basic echocardiographic parameters and atrial electromechanical delay times (EMD) measured via tissue Doppler imaging.

RESULTS: No significant changes were observed in intra-atrial EMD times. However, significant reductions were noted in interatrial EMD times, decreasing from 15.13 ± 5.87 ms to 13.20 ± 6.12 ms (P = 0.029). Statistically significant shortening occurred in lateral pulmonary acceleration (PA) times (from 58.73 ± 6.41 ms to 54.37 ± 6.97 ms, P < 0.001), septal PA times (from 50.90 ± 6.02 ms to 48.23 ± 5), and tricuspid PA times (from 43.60 ± 6.28 ms to 41.30 ± 5.60 ms, P = 0.003). Additionally, there was a significant reduction in the E/e’ ratio from 8.13 ± 4.0 to 6.50 ± 2.37 (P = 0.003).

CONCLUSION: SGLT-2 inhibitors might positively influence atrial electromechanical conduction, reducing DM-related functional impairments and the risk of arrhythmias, particularly AF.

PMID:38829634 | DOI:10.5543/tkda.2024.27546

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Evaluation of Procedure Doses and Staff Attitudes in Interventional Cardiology in Terms of Radiation Safety

Turk Kardiyol Dern Ars. 2024 Jun;52(4):260-268. doi: 10.5543/tkda.2024.18363.

ABSTRACT

OBJECTIVE: Ionizing radiation has long been used in the medical field. Catheter laboratories (cath labs) are recognized as areas where radiation exposure is notably high. This study aims to examine the levels of radiation exposure during various interventional procedures to raise awareness of this issue in Türkiye.

METHODS: This study evaluated the procedure radiation doses (n = 2804) in the cath labs of four public hospitals with distinct characteristics. Radiation dose evaluation was conducted using Cumulative Air Kerma (CAK). The Kolmogorov-Smirnov test, Kruskal-Wallis H test, independent T-test, and Pearson correlation coefficient were utilized to analyze the data. A p-value of < 0.05 was considered statistically significant. Data were analyzed using IBM® Statistical Package for the Social Sciences (SPSS®) STATISTICS Version 26.0.0.0 (IBM Corporation, Armonk, New York, USA).

RESULTS: The procedure radiation doses in the cath labs were documented. The findings are largely consistent with the literature. Notably, several outlier cases with extremely high radiation doses were identified [CAK (min-max) = 0.12 – 9.9 Gy]. Procedures such as chronic total occlusion (CTO) [Mean CAK: 3.8 (± 1.5) Gy] and percutaneous coronary interventions (PCI) [Mean CAK: 1.5 (± 1.4) Gy] were associated with high doses. Additionally, personnel attitudes toward radiation optimization in cath labs were found to be inadequate.

CONCLUSION: The incidence of high radiation exposure during interventional procedures may be higher than expected in Türkiye. Further research is necessary to identify predictors and implement preventive measures to reduce these rates. For this purpose, establishing diagnostic radiation reference levels (DRLs) could help monitor national radiation levels.

PMID:38829631 | DOI:10.5543/tkda.2024.18363

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Type 1 Myocardial Infarction in Patients With Acute Ischemic Stroke

JAMA Neurol. 2024 Jun 3. doi: 10.1001/jamaneurol.2024.1552. Online ahead of print.

ABSTRACT

IMPORTANCE: Elevated values of high-sensitivity cardiac troponin (hs-cTn) are common in patients with acute ischemic stroke and are associated with poor prognosis. However, diagnostic and therapeutic implications in patients with ischemic stroke remain unclear.

OBJECTIVE: To identify factors indicative of myocardial infarction (MI) in patients with acute ischemic stroke and hs-cTn elevation. The primary hypothesis was that a dynamic change of hs-cTn values (>50% change) in patients with acute ischemic stroke indicates MI.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study was a prospective, observational study with blinded end-point assessment conducted across 26 sites in Germany. Patients were included if they had acute ischemic stroke within 72 hours and either (1) highly elevated hs-cTn values on admission (>52 ng/L) or (2) hs-cTn levels above the upper limit of normal and a greater than 20% change at repeated measurements. Patients were enrolled between August 2018 and October 2020 and had 1 year of follow-up. Statistical analysis was performed between April 2022 and August 2023.

EXPOSURE: Standardized electrocardiography, echocardiography, and coronary angiography.

MAIN OUTCOME AND MEASURES: Diagnosis of MI as adjudicated by an independent end-point committee based on the findings of electrocardiography, echocardiography, and coronary angiography.

RESULTS: In total, 254 patients were included. End points were adjudicated in 247 patients (median [IQR] age, 75 [66-82] years; 117 were female [47%] and 130 male [53%]). MI was present in 126 of 247 patients (51%) and classified as type 1 MI in 50 patients (20%). Dynamic change in hs-cTn value was not associated with MI in univariable (32% vs 38%; χ2 P = .30) or adjusted comparison (odds ratio, 1.05; 95% CI, 0.31-3.33). The baseline absolute hs-cTn value was independently associated with type 1 MI. The best cutoffs for predicting type 1 MI were at hs-cTn values 5 to 10 times the upper limit normal.

CONCLUSIONS AND RELEVANCE: This study found that in patients with acute ischemic stroke, a dynamic change in hs-cTn values did not identify MI, underscoring that dynamic changes do not identify the underlying pathophysiological mechanism. In exploratory analyses, very high absolute hs-cTn values were associated with a diagnosis of type 1 MI. Further studies are needed how to best identify patients with stroke who should undergo coronary angiography.

PMID:38829625 | DOI:10.1001/jamaneurol.2024.1552

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Metabolic Surgery in Patients With High BMI and Obesity

JAMA Netw Open. 2024 Jun 3;7(6):e2414351. doi: 10.1001/jamanetworkopen.2024.14351.

NO ABSTRACT

PMID:38829620 | DOI:10.1001/jamanetworkopen.2024.14351

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Surgeon and Surgical Trainee Experiences After Adverse Patient Events

JAMA Netw Open. 2024 Jun 3;7(6):e2414329. doi: 10.1001/jamanetworkopen.2024.14329.

ABSTRACT

IMPORTANCE: Adverse patient events are inevitable in surgical practice.

OBJECTIVES: To characterize the impact of adverse patient events on surgeons and trainees, identify coping mechanisms, and assess whether current forms of support are sufficient.

DESIGN, SETTING, AND PARTICIPANTS: In this mixed-methods study, a validated survey instrument was adapted and distributed to surgical trainees from 7 programs, and qualitative interviews were conducted with faculty from 4 surgical departments in an urban academic health system.

MAIN OUTCOMES AND MEASURES: The personal impact of adverse patient events, current coping mechanisms, and desired forms of support.

RESULTS: Of 216 invited trainees, 93 (43.1%) completed the survey (49 [52.7%] male; 60 [64.5%] in third postgraduate year or higher; 23 [24.7%] Asian or Pacific Islander, 6 [6.5%] Black, 51 [54.8%] White, and 8 [8.6%] other race; 13 [14.0%] Hispanic or Latinx ethnicity). Twenty-three of 29 (79.3%) invited faculty completed interviews (13 [56.5%] male; median [IQR] years in practice, 11.0 [7.5-20.0]). Of the trainees, 77 (82.8%) endorsed involvement in at least 1 recent adverse event. Most reported embarrassment (67 of 79 trainees [84.8%]), rumination (64 of 78 trainees [82.1%]), and fear of attempting future procedures (51 of 78 trainees [65.4%]); 28 of 78 trainees (35.9%) had considered quitting. Female trainees and trainees who identified as having a race and/or ethnicity other than non-Hispanic White consistently reported more negative consequences compared with male and White trainees. The most desired form of support was the opportunity to discuss the incident with an attending physician (76 of 78 respondents [97.4%]). Similarly, faculty described feelings of guilt and shame, loss of confidence, and distraction after adverse events. Most described the utility of confiding in peers and senior colleagues, although some expressed unwillingness to reach out. Several suggested designating a departmental point person for event debriefing.

CONCLUSIONS AND RELEVANCE: In this mixed-methods study of the personal impact of adverse events on surgeons and trainees, these events were nearly universally experienced and caused significant distress. Providing formal support mechanisms for both surgical trainees and faculty may decrease stigma and restore confidence, particularly for underrepresented groups.

PMID:38829617 | DOI:10.1001/jamanetworkopen.2024.14329

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Clinical validation of the accuracy of an intra-operative assessment tool using 3D ultrasound compared to histopathology in patients with squamous cell carcinoma of the tongue

Eur Arch Otorhinolaryngol. 2024 Jun 3. doi: 10.1007/s00405-024-08753-3. Online ahead of print.

ABSTRACT

BACKGROUND: Histopathological analysis often shows close resection margins after surgical removal of tongue squamous cell carcinoma (TSCC). This study aimed to investigate the agreement between intraoperative 3D ultrasound (US) margin assessment and postoperative histopathology of resected TSCC.

METHODS: In this study, ten patients were prospectively included. Three fiducial cannulas were inserted into the specimen. To acquire a motorized 3D US volume, the resected specimen was submerged in saline, after which images were acquired while the probe moved over the specimen. The US volumes were annotated twice: (1) automatically and (2) manually, with the automatic segmentation as initialization. After standardized histopathological processing, all hematoxylin-eosin whole slide images (WSI) were included for analysis. Corresponding US images were found based on the known WSI spacing and fiducials. Blinded observers measured the tumor thickness and the margin in the caudal, deep, and cranial directions on every slide. The anterior and posterior margin was measured per specimen.

RESULTS: The mean difference in all measurements between manually segmented US and histopathology was 2.34 (SD: ±3.34) mm, and Spearman’s rank correlation coefficient was 0.733 (p < 0.001). The smallest mean difference was in the tumor thickness with 0.80 (SD: ±2.44) mm and a correlation of 0.836 (p < 0.001). Limitations were observed in the caudal region, where no correlation was found.

CONCLUSION: This study shows that 3D US and histopathology have a moderate to strong statistically significant correlation (r = 0.733; p < 0.001) and a mean difference between the modalities of 2.3 mm (95%CI: -4.2; 8.9). Future research should focus on patient outcomes regarding resection margins.

PMID:38829555 | DOI:10.1007/s00405-024-08753-3

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Expediting the reversal of inferior alveolar nerve block anesthesia in children with photobiomodulation therapy

Lasers Med Sci. 2024 Jun 3;39(1):148. doi: 10.1007/s10103-024-04096-x.

ABSTRACT

In pediatric dentistry, complications arising from extended soft tissue anesthesia can negatively impact patient comfort and trust in dental care. This study evaluates the clinical efficacy of diode laser-based photobiomodulation therapy (PBMT) in expediting the resolution of anesthesia in children aged 6-9 receiving inferior alveolar nerve block (IANB) injections. In this split-mouth double-blind randomized clinical trial, 36 pediatric subjects aged 6-9, requiring pulpotomy procedures on both sides of the mandible, received IANBs (single cartridge of 2% lidocaine/1:100,000 epinephrine). PBMT and sham laser were alternately applied to each side of the mandible, in two separate sessions, with the envelope method determining treatment allocation and intervention side on the first treatment day. During the laser session, laser (808 nm, 250 mW, 23s continuous, 0.5 cm², 11.5 J/cm², direct contact) irradiated two points at the injection site, five intra-oral and five extra-oral points along the infra-alveolar nerve’s pathway. Soft tissue anesthesia reversal was quantified through tactile assessment. Soft tissue trauma was also assessed by the researcher and reported by parents 24 h post-dental visit. All data were analyzed using IBM SPSS Statistics v25.0 via Paired T-test, two-way repeated measures ANOVA, and McNemar’s test. The laser group exhibited a mean lip anesthesia duration of 122.78 ± 2.26 min, while the sham laser group experienced 134.44 ± 21.8 min, indicating an 11.66-minute reduction in anesthesia duration for the laser group. (P < 0.001) Soft tissue trauma occurred in two sham laser group patients and one laser group patient, with no significant difference. (P = 1) The findings indicate that employing laser with defined parameters can reduce the length of IANB-induced anesthesia.

PMID:38829548 | DOI:10.1007/s10103-024-04096-x