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Nevin Manimala Statistics

The spectrum of psychological disorders in family members of patients suffering from delirium associated with critical illness: a prospective, observational study

Sci Rep. 2024 Feb 24;14(1):4562. doi: 10.1038/s41598-024-53968-3.

ABSTRACT

During intensive care unit admission, relatives of critically ill patients can experience emotional distress. The authors hypothesized that families of patients who are diagnosed with intensive care unit (ICU) delirium experience more profound depression and anxiety disorders related to stress than do families of patients without delirium. We performed a prospective observational single-center study including families of adult patients (age above 18 years) hospitalized in a 17-bed ICU of a university hospital for at least 48 h who completed research questionnaires at day 2 after admission and day 30 after initial evaluation using dedicated questionnaires (HADS, CECS, IES, PTSD-C). A total of 98 family members of patients hospitalized in the ICU were included in the final analysis (50 family members whose relatives were CAM-ICU positive (DEL+), and 48 family members of patients without delirium (DEL-)). No statistically significant differences in demographics and psychosocial data were found between the groups. In the follow-up 30 days after the first conversation with a family member, the mean PTSD score for the relatives of patients with delirium was 11.02 (Me = 13.0; SD = 5.74), and the mean score for nondelirious patients’ family members was 6.42 (Me = 5.5; SD = 5.50; p < 0.001). A statistically significant increase in IES scores for family members of patients with delirium was observed for total PTSD (p = 0.001), IES-intrusion (p < 0.001), and IES-hyperarousal (p = 0.002). The prevalence of anxiety symptoms, depression, and posttraumatic stress disorder (PTSD) was higher in families of patients diagnosed with ICU delirium within 48 h of admission to the ICU. No factors increasing the depth of these disorders in family members of patients with ICU delirium were identified. Taking appropriate actions and thus providing families with appropriate support will contribute to the understanding of unfavorable emotional states, including anxiety, stress, depression, anger, agitation, or avoidance.

PMID:38402273 | DOI:10.1038/s41598-024-53968-3

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Designing and psychometric assessment of the moral intelligence scale for healthcare professionals

Sci Rep. 2024 Feb 24;14(1):4515. doi: 10.1038/s41598-024-55052-2.

ABSTRACT

The moral intelligence of healthcare professionals in the cardiac operating room is one of the most important aspects of professional competence. However, moral intelligence is an abstract and multidimensional concept that needs to be clarified and described based on organizational culture and environment. Therefore, there is a need to design a specific scale for measuring the moral intelligence of healthcare professionals in the cardiac operating room. This study aims to design and assess the psychometric properties of a moral intelligence scale for healthcare professionals in the cardiac operating room. The present study was a mixed method study with a sequential exploratory approach. The research was conducted in 2023-2024 in Iran. The first phase data were collected from 20 healthcare professionals and were analyzed by conventional content analysis method. In the second phase, the validity and reliability of the instrument were evaluated by involving 300 healthcare professionals in the cardiac operating room. The moral intelligence of health care professionals in the cardiac operating room was defined as moral sensitivity combined with moral commitment and moral courage for the provision of quality care that respects the principles of medical ethics. After deducing the conceptual framework, the moral intelligence scale for healthcare professionals in the cardiac operating room was developed with three dimensions: “moral sensitivity,” “moral commitment,” and “moral courage.” 11 items were removed during testing to ensure content validity. Face validity was confirmed with impact scores > 1.5 for all items. A scale was developed through factor analysis with three factors that accounted for 73.04% of the observed variance. The instrument’s reliability using Cronbach’s alpha coefficient calculation was reported as 0.94 for the entire instrument. The testretest showed no statistically significant difference between the pre and post-test scores of moral intelligence (p = 0.51). The moral intelligence scale demonstrated acceptable psychometric properties. The moral intelligence scale for health care professionals in the cardiac operating room demonstrated acceptable psychometric properties. This instrument may serve to assess the moral intelligence of healthcare professionals and determine the need for educational interventions to reduce the ethical challenges and improve the moral intelligence of this healthcare.

PMID:38402272 | DOI:10.1038/s41598-024-55052-2

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Nevin Manimala Statistics

Early Versus Late Drainage Removal in Patients Who Underwent Pancreaticoduodenectomy: A Comprehensive Systematic Review and Meta-analysis of Randomized Controlled Trials Using Trial Sequential Analysis

Ann Surg Oncol. 2024 Feb 24. doi: 10.1245/s10434-024-14959-w. Online ahead of print.

ABSTRACT

BACKGROUND: The superiority of early drain removal (EDR) versus late (LDR) after pancreaticoduodenectomy (PD) has been demonstrated only in RCTs.

METHODS: A meta-analysis was conducted using a random-effects model and trial sequential analysis. The critical endpoints were morbidity, redrainage, relaparotomy, and postoperative pancreatic fistula (CR-POPF). Hemorrhage (PPH), delayed gastric emptying (DGE), length of stay (LOS), and readmission rates were also evaluated. Risk ratios (RRs) and mean differences (MDs) with a 95% confidence interval (CI) were calculated. Type I and type II errors were excluded, comparing the accrued sample size (ASS) with the required sample size (RIS). When RIS is superior to ASS, type I or II errors can be hypothesized.

RESULTS: ASS was 632 for all endpoints except DGE and PPH (557 patients). The major morbidity (RR 0.55; 95% CI 0.32-0.97) was lower in the EDR group. The CR-POPF rate was lower in the EDR than in the LDR group (RR 0.50), but this difference is not statistically significant (95% CI 0.24-1.03). The RIS to confirm or exclude these results can be reached by randomizing 5959 patients. The need for percutaneous drainage, relaparotomy, PPH, DGE, and readmission rates was similar. The related RISs were higher than ASS, and type II errors cannot be excluded. LOS was shorter in the EDR than the LDR group (MD – 2.25; 95% CI – 3.23 to – 1.28). The RIS was 567, and type I errors can be excluded.

CONCLUSIONS: EDR, compared with LDR, is associated with lower major morbidity and shorter LOS.

PMID:38402268 | DOI:10.1245/s10434-024-14959-w

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Mesenchymal stem cells-derived extracellular vesicles for therapeutics of renal tuberculosis

Sci Rep. 2024 Feb 24;14(1):4495. doi: 10.1038/s41598-024-54992-z.

ABSTRACT

Extrapulmonary tuberculosis with a renal involvement can be a manifestation of a disseminated infection that requires therapeutic intervention, particularly with a decrease in efficacy of conventional regimens. In the present study, we investigated the therapeutic potency of mesenchymal stem cell-derived extracellular vesicles (MSC-EVs) in the complex anti-tuberculosis treatment (ATT). A rabbit model of renal tuberculosis (rTB) was constructed by injecting of the standard strain Mycobacterium tuberculosis H37Rv into the cortical layer of the kidney parenchyma. Isolated rabbit MSC-EVs were intravenously administered once as an addition to standard ATT (isoniazid, pyrazinamide, and ethambutol). The therapeutic efficacy was assessed by analyzing changes of blood biochemical biomarkers and levels of anti- and pro-inflammatory cytokines as well as by renal computed tomography with subsequent histological and morphometric examination. The therapeutic effect of therapy with MSC-EVs was shown by ELISA method that confirmed a statistically significant increase of the anti-inflammatory and decrease of pro-inflammatory cytokines as compared to conventional treatment. In addition, there is a positive trend in increase of ALP level, animal weigh, and normalization of ADA activity that can indicate an improvement of kidney state. A significant reduction of the area of specific and interstitial inflammation indicated positive affect of MSC-EVs that suggests a shorter duration of ATT. The number of MSC-EVs proteins (as identified by mass-spectometry analysis) with anti-microbial, anti-inflammatory and immunoregulatory functions reduced the level of the inflammatory response and the severity of kidney damage (further proved by morphometric analysis). In conclusion, MSC-EVs can be a promising tool for the complex treatment of various infectious diseases, in particularly rTB.

PMID:38402260 | DOI:10.1038/s41598-024-54992-z

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Nevin Manimala Statistics

Remote Sensing-Based Extension of GRDC Discharge Time Series – A Monthly Product with Uncertainty Estimates

Sci Data. 2024 Feb 24;11(1):240. doi: 10.1038/s41597-024-03078-6.

ABSTRACT

The Global Runoff Data Center (GRDC) data set has faced a decline in the number of active gauges since the 1980s, leaving only 14% of gauges active as of 2020. We develop the Remote Sensing-based Extension for the GRDC (RSEG) data set that can ingest legacy gauge discharge and remote sensing observations. We employ a stochastic nonparametric mapping algorithm to extend the monthly discharge time series for inactive GRDC stations, benefiting from satellite imagery- and altimetry-derived river width and water height observations. After a rigorous quality assessment of our estimated discharge, involving statistical validation, tests and visual inspection, results in the extension of discharge records for 3377 out of 6015 GRDC stations. The quality of discharge estimates for the rivers with a large or medium mean discharge is quite satisfactory (average KGE value > 0.5) however for river reaches with a low mean discharge the average KGE value drops to 0.33.The RSEG data set regains monitoring capability for 83% of total river discharge measured by GRDC stations, equivalent to 7895 km3/month.

PMID:38402251 | DOI:10.1038/s41597-024-03078-6

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Incidence of immunotherapy-related hyperprogressive disease (HPD) across HPD definitions and cancer types in observational studies: A systematic review and meta-analysis

Cancer Med. 2024 Feb;13(3):e6970. doi: 10.1002/cam4.6970.

ABSTRACT

BACKGROUND: While evidence of hyperprogressive disease (HPD) continues to grow, the lack of a consensual definition obscures a proper characterization of HPD incidence. We examined how HPD incidence varies by the tumor type or the type of definition used.

METHODS: We searched PubMed, Embase, the Cochrane Library of Systematic Reviews, and Web of Science from database inception to June 21, 2022. Observational studies reporting HPD incidence, in patients diagnosed with solid malignant tumors and treated with immune checkpoint inhibitors (ICI), were included. Random-effects meta-analyses were performed, and all statistical tests were 2-sided.

RESULTS: HPD incidence was 12.4% (95% CI 10.2%-15.0%) with evidence of heterogeneity (Q = 119.32, p < 0.001). Meta-regression showed that the risk of developing HPD was higher in patients with advanced gastric cancer (adjusted odds ratio [OR], 10.83; 95% CI, 2.14-54.65; p < 0.001), hepatocellular carcinoma (adjusted OR, 7.99; 95% CI, 1.68-38.13; p = 0.006), non-small cell lung cancer (adjusted OR, 7.14; 95% CI, 1.58-32.29; p = 0.005), and mixed or other types (adjusted OR, 5.09; 95% CI, 1.12-23.14, p = 0.018) than in patients with renal cell carcinoma. Across definitions, HPD defined as a tumor growth kinetics ratio ≥ 2 (adjusted OR, 1.82; 95% CI, 1.08-3.07; p = 0.025) based on the Response Evaluation Criteria in Solid Tumors (RECIST) reported higher incidence than when HPD was defined as RECIST-defined progressive disease and a change in the tumor growth rate (TGR) exceeding 50% (∆TGR > 50).

CONCLUSIONS: The incidence of immunotherapy-related HPD may vary across tumor types and definitions used, supporting the argument for a uniform and improved method of HPD evaluation for informed clinical decision-making.

PMID:38400685 | DOI:10.1002/cam4.6970

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Association between personality types and low anterior resection syndrome in rectal cancer patients following surgery

Cancer Med. 2024 Feb;13(3):e7022. doi: 10.1002/cam4.7022.

ABSTRACT

PURPOSE: Low anterior resection syndrome (LARS) has had many impacts on the lives of patients and substantial differences in emotional and social functions. The aim of this study was to investigate the correlation analysis of different personality traits in rectal cancer patients with LARS after undergoing curative surgery.

METHODS: This study was designed as a prospective cohort study. The inclusion criteria included (1) participants diagnosed with rectal cancer who underwent surgical resection of malignant tumors and (2) ECOG 0-1. The primary outcome was the correlation between different personality traits and low anterior resection syndrome in rectal cancer patients after radical surgery. Low anterior resection syndrome incidence rates were estimated by questionnaires and personality groups by the Type A and Type D Scale-14 Personality Inventory.

RESULTS: For all 161 participants in this study, the presence of a tumor at the lower anal verge and the receipt of neoadjuvant CCRT had a statistically significant positive correlation with the LARS score at 1 month, 6 months, and 1 year (Pearson correlation coefficient = -0.283, -0.374, and – 0.205, respectively), with a p value of less than 0.05. Personalities with Type A, Type D, and Type D-SI scores had a statistically significant positive correlation with LARS score at 1 month (Pearson correlation coefficient = 0.172, 0.162, and 0,164, p value = 0.03, 0.04, and 0.04).

CONCLUSION: Type A and Type D personalities are highly linked to LARS. Personalized support approaches can ultimately assist rectal cancer patients in overcoming difficulties after surgery and recovery and enhance their functional outcomes.

PMID:38400678 | DOI:10.1002/cam4.7022

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What do cancer patients experience of the simultaneous care clinic? Results of a cross-sectional study on patient care satisfaction

Cancer Med. 2024 Feb;13(3):e7000. doi: 10.1002/cam4.7000.

ABSTRACT

BACKGROUND: Veneto Institute of Oncology has activated a simultaneous care outpatient clinic (SCOC) in which cancer patients with advanced-stage cancer are evaluated by oncologist and palliative care specialists. This cross-sectional study investigated patients’ perceptions of the quality of this service.

MATERIALS AND METHODS: An ad-hoc self-administered questionnaire, developed by SCOC team, was used to assess the satisfaction of patients admitted at SCOC consultation. The questionnaire, in addition to the socio-demographic questions, contains eight questions with the Likert scale: time dedicated, feel listened to, feel understood, feel free to speak openly and to express doubts and concerns, feeling about information and indication received, level of empathy of health care and quality of the relationship, level of professional/quality of performance and utility of consultation, and one open-ended question. The questionnaire has been proposed to all 174 consecutively admitted patients at SCOC.

RESULTS: One hundred and sixty-two patients filled in the questionnaire: 66.7% were male, median age was 71 years, 88.3% had metastatic disease. The time dedicated to SCOC consultation was judged more than adequate (55%) or adequate (35%) by 90% of subjects. Patients completely satisfied about being listened to were 92.5%, with 80.9% being completely satisfied with understanding of their issues and 92% with the freedom to speak and express doubts. Usefulness of the SCOC was rated as excellent by 40% and good by 54.4% of patients. No statistically significant differences were observed in the responses to the questions by gender, age (< or ≥70 years old) and type of tumor.

CONCLUSION: Our study shows high levels of satisfactions after SCOC consultation in advanced cancer subjects. Patients’ feedback confirmed that SCOC model was effective in helping them during their treatment journey and decision at the end of life. This study encouraged us to enhance our practice of SCOC consultation.

IMPLICATIONS FOR PRACTICE: A joint evaluation of patients living with cancer by oncologist and palliative care team (SCOC-embedded model), has shown to enhance patients’ experience/satisfaction with care-such as listening, understanding, receiving information, symptom control, and decision about future, independently of age, gender, and kind of tumor.

PMID:38400662 | DOI:10.1002/cam4.7000

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A multicenter, real-world study on effectiveness and safety of first-line modified PD-1 inhibitors with chemotherapy in advanced non-small cell lung cancer (aNSCLC) with drive gene-negative

Cancer Med. 2024 Feb;13(3):e7024. doi: 10.1002/cam4.7024.

ABSTRACT

OBJECTIVES: The use of immune checkpoint inhibitors, particularly PD-1 inhibitors, has revolutionized the treatment of advanced tumors and shown significant improvements in patient survival rates. However, which PD-1 inhibitor is more effective and safer for a specific indication remains unclear. To address this problem, our study aimed to evaluate the effectiveness and safety of different PD-1 inhibitors in combination with chemotherapy as first-line therapy for individuals with advanced non-small-cell lung cancer (NSCLC) without driver genes in the real world.

MATERIALS AND METHODS: We conducted a retrospective study of individuals diagnosed with aNSCLC who received immune checkpoint inhibitors (ICIs) with modified PD-1 inhibitors, including Sintilimab, Toripalimab, Tislelizumab, Camrelizumab, or Pembrolizumab as first-line treatment between March 5th, 2016 and October 20th, 2022. We assessed demographic and clinical information and analyzed clinical response, survival outcomes, and safety profiles. The primary endpoint was overall survival (OS), and the secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety.

RESULTS: As of the date cut-off on October 20th, 2022, the median follow-up time was 20.62 months. A total of 204 patients were enrolled in the study, including 56 (27.5%) patients receiving modified PD-1 inhibitors (Sintilimab, Toripalimab, Tislelizumab, or Camrelizumab) in combination with chemotherapy and 148 (72.5%) patients receiving Pembrolizumab in combination with chemotherapy. In the overall cohort, the median overall survival (OS) was 26.9 months (95%CI, 22.3-31.6), the median progression-free survival (PFS) was 8.4 months (95%CI, 6.9-9.8), and the objective response rate (ORR) and disease control rate (DCR) were 47.6% (95%CI, 29.9-43.6) and 84.3% (95%CI, 78.4-88.9). The mOS of modified PD-1 inhibitors group and Pembrolizumab group were 30.7 (95%CI, 17.3-44.4) months and 26.8 (95%CI, 22.2-31.4) months. The mPFS of two groups were 8.3(95%CI, 6.9-9.6) months and 8.8 (95%CI, 6.9-10.7) months, respectively. There was no statistical difference between the two groups in terms of OS or PFS. The ORR for the two groups was 48.2% (95%CI, 34.8-61.8) and 47.3% (95%CI, 39.1-5.6), respectively. However, due to the limited sample size, the difference was not statistically significant. On the other hand, the DCR tended to be higher in the Pembrolizumab group (86.5%; 95%CI, 79.7-91.4) compared to the modified PD-1 inhibitors group (78.6%; 95%CI, 65.2-87.9), and this difference was statistically significant (p = 0.006). In terms of safety, both groups exhibited favorable clinical safety profiles. The only two types of potentially immune-related adverse events reported were pneumonitis and reactive cutaneous capillary endothelial proliferation (RCCEP).

CONCLUSIONS: The modified PD-1 inhibitors showed comparable survival outcomes and manageable safety profiles in NSCLC compared to Pembrolizumab. Moreover, these inhibitors exhibited improved accessibility and economic outcomes compared to Pembrolizumab. While there were similarities in drug-related and immunotherapy-related adverse reactions between the modified PD-1 inhibitors and Pembrolizumab, there were some slight differences. Further prospective and retrospective studies would be necessary to validate these findings beyond the scope of the CTONG1901 study.

PMID:38400661 | DOI:10.1002/cam4.7024

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Effect of hemodialysis on left atrial function in patients with end-stage renal failure evaluated by two-dimensional speckle tracking imaging

Echocardiography. 2024 Feb;41(2):e15784. doi: 10.1111/echo.15784.

ABSTRACT

OBJECTIVE: We sought to evaluate the left atrial (LA) strain parameters of maintenance hemodialysis (MHD) patients before and after dialysis by two dimensional speckle tracking imaging (2D-STI), and to explore the effect of volume load change on LA function.

METHODS: Seventy-six patients with end stage renal disease (ESRD) on hemodialysis (HD) were enrolled in the study protocol. The median duration of dialysis was 24.0 (7.5, 59.5) months. In addition, 30 healthy subjects were selected as control group. Comprehensive echocardiography was performed immediately before and after hemodialysis to compare the changes in left atrial function.

RESULTS: Regarding LA strain parameters in patients of pre-HD, the median (25th, 75th) LA reservoir, LA conduit, and LA contractile reserve were 28.0 (23.0, 34.5), -15.5 (-10.0, -21.5), -12.0 (-9.0, -16.0) respectively; the post-HD were 26.0 (21.0, 29.0), -12.0 (-9, -15.5), -12.5 (-9, -15.5) respectively; and controls were 43.0 (36.0, 48.0), -24.0 (-18.0, -32.0), -17.0 (-15.0, -22.0) respectively. The left atrial strain parameters before HD were lower than controls, the differences were statistically significant, the p-value were .000, .025, and .000, respectively. The reservoir function and conduit function of LA strain decreased after hemodialysis, the differences were statistically significant, the p-value were .003 and .006, respectively. Regarding the contraction of LA, the differences between pre- and post-HD were not statistically significant (p = .965).

CONCLUSION: Hemodialysis removes excess water in human body, while LVGLS and Doppler parameters are greatly affected by reduced preload. New echocardiographic parameters, such as left atrial strain, can quantitatively evaluate the changes in left atrial function before and after hemodialysis in ESRD patients, which can provide valuable information for the overall cardiac evaluation in this specific population.

PMID:38400659 | DOI:10.1111/echo.15784