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Nevin Manimala Statistics

Is the CRAFITY score a superior predictor of prognosis and adverse events in hepatocellular carcinoma patients treated with locoregional-immunotherapy?

Hepatol Int. 2023 May 2. doi: 10.1007/s12072-023-10535-8. Online ahead of print.

ABSTRACT

BACKGROUND: The level of C‑reactive protein (CRP) and alpha‑fetoprotein (AFP) in immunotherapy (CRAFITY) score was associated with the prognosis of hepatocellular carcinoma (HCC) patients treated with immunotherapy. Based on the CRAFITY score, this study aimed to investigate the efficacy and safety of locoregional-immunotherapy for treating HCC patients.

METHODS: HCC patients who received locoregional-immunotherapy were consecutively recruited at Sun Yat-sen University Cancer Center in 2019. CRAFITY 0 score was defined as the AFP level below 100 ng/ml and a CRP level of less than 1 mg/dl, CRAFITY 1 score was defined as the AFP level of at least 100 ng/ml or the CRP level of at least 1 mg/dl, and CRAFITY 2 score was defined as both the AFP level over 100 ng/ml and the CRP level of more than 1 mg/dl. The primary outcomes were progression-free survival (PFS) and overall survival (OS). The second outcomes were tumor response rate and treatment-related adverse events (AEs).

RESULTS: The median PFS for HCC patients with the CRAFITY 0 score was not estimable. The PFS was 11.0 months [95% confidence interval (CI) 7.2-14.9] and 6.0 months (95% CI 4.2-7.8) for patients with CRAFITY 1 and 2 scores, respectively, with a significant difference between the two groups (p < 0.001). HCC patients with CRAFITY 0, 1, and 2 scores had 3 years OS rates of 63.8%, 60.8%, and 32.1%, respectively, with statistical differences among the three groups (p < 0.001). Patients with the CRAFITY 2 score were more likely to experience fever than those with other scores (p < 0.05). A greater CRAFITY score was correlated with a higher incidence of grade 3 and above liver injury (p < 0.01).

CONCLUSIONS: The CRAFITY score is a superior predictor of prognosis and treatment-related AEs in HCC patients treated with locoregional-immunotherapy.

PMID:37129721 | DOI:10.1007/s12072-023-10535-8

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Impact of essential amino acid intake, resistance exercise, and aging on the concentration of Achilles peritendinous amino acids and procollagen Iα1 in humans

Amino Acids. 2023 May 2. doi: 10.1007/s00726-023-03268-3. Online ahead of print.

ABSTRACT

Recent studies have shown that consuming amino acid-rich compounds improves tendon collagen content and biomechanical properties. Yet, it is unclear if the consumption of amino acids alters local (peritendinous) amino acid concentrations. If aging or exercise influence local amino acid concentrations in conjunction with an amino acid bolus is also not known. We conducted two studies. In Study 1, young women (n = 7, 25 ± 2 years) completed two identical resistance training sessions with either essential amino acid (EAA) or placebo consumption. In Study 2, an EAA bolus identical to Study 1 was given to younger (n = 7; 27 ± 1 year) and older adults (n = 6; 68 ± 2 years). Microdialysis was used to determine Achilles peritendinous amino acid and pro-collagen Iα1 (a marker of collagen synthesis) concentrations. In Study 1, amino acid consumption increased peritendinous concentrations of all EAA except histidine (p < 0.05). In Study 2, the peritendinous concentration of EAAs except for methionine, histidine, and lysine (p > 0.05) increased with time (p < 0.05). Further, the concentrations of most measured amino acids were greater in older adults (p < 0.05). Pro-collagen Iα1 concentration (p > 0.05) was unaffected by exercise, EAA, or aging (p > 0.05). Our findings demonstrate the following: (1) when not combined with exercise, an oral EAA bolus leads to only modest increases in Achilles peritendinous amino acid concentrations; (2) when combined with resistance exercise, EAA consumption resulted in greater peritendinous amino acid concentrations compared to no exercise; (3) the basal concentrations of most amino acids were greater in older adults, and (4) neither the EAA bolus nor exercise altered peritendinous pro-collagen concentrations.

PMID:37129720 | DOI:10.1007/s00726-023-03268-3

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The Economic Impact of Standardization and Digitalization in the Operating Room: A Systematic Literature Review

J Med Syst. 2023 May 2;47(1):55. doi: 10.1007/s10916-023-01945-0.

ABSTRACT

Hospital face increased resource constraints and competition. This escalates the need for efficiency optimization especially in resource-intense areas, such as the Operating Room (OR). Efficiency cannot happen at expenses of patient outcomes. Innovative digital support systems (DSS) have been introduced into the market to support established standardization methods of intraoperative workflows further. This review aimed to analyze whether applied standardization methods and implemented DSS of intraoperative surgical workflows lead to increasing efficiency and demonstrate economic improvements. A systematic review of intraoperative surgical workflows standardization and digitalization was performed. Journal articles and reviews from 2000 to 2023 were retrieved from EBSCO, PubMed, and Scopus databases, as well as the internal database of Johnson & Johnson. 17 articles showed a significant increase in efficiency through standardization, which led to cost reductions between $70.20 to $3,516 per case without negatively impacting quality. Five additional articles on DSS demonstrated a significant positive impact on efficiency and quality. Reduction in OR-time between 6 to 22% per case was one main contributor. No literature on DSS revealed any correlated economic impact. Selected standardization methods and introduced DSS for intraoperative surgical workflows effectively increase efficiency while maintaining or even improving quality. Demonstrated cost-effectiveness of non-digital standardization methods across surgical areas requires more research on complex and resource-intensive procedures and the economic value of DSS to support hospital management’s strategic decisions to overcome the increasing economic burden.

PMID:37129717 | DOI:10.1007/s10916-023-01945-0

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Prevalence of glucocorticoid-induced osteoporosis among rheumatology patients in Africa: a systematic review and meta-analysis

Arch Osteoporos. 2023 May 2;18(1):59. doi: 10.1007/s11657-023-01246-6.

ABSTRACT

The prevalence of glucocorticosteroid-induced osteoporosis (GIOP) is well established in higher income countries. There are limited studies showing a wide prevalence of GIOP in Africa. Prospective studies are needed on GIOP in African rheumatology patients to implement appropriate management algorithms.

PURPOSE: The prevalence of glucocorticosteroid-induced osteoporosis (GIOP) is well established in developed countries, but little is known about GIOP in African adult patients with inflammatory rheumatic musculoskeletal diseases (RMDs). This study aimed to determine the prevalence of GIOP and osteoporotic fracture risk in African patients with inflammatory RMDs according to radiographic and bone mineral density (BMD) findings.

METHODS: PubMed, Google Scholar, Scopus, and African Index Medicus were searched up to 31 December 2020. Heterogeneity was assessed using I2 statistic across the included studies. A random-effects model was applied to estimate the pooled effect size across studies. All statistical analyses were performed using STATA™ version 14 software. The study was registered with PROSPERO, number CRD42021256252.

RESULTS: In this meta-analysis, a total of 7 studies with 780 participants, stratified by geographical region were included. The pooled prevalence of GIOP based on BMD data was 47.7% (95% CI 32.9-62.8) with 52.2% (95% CI 36.5-67.6) in North African countries and 15.4% (95% 1.9-45.4%) in South Africa with a high heterogeneity (I2 = 93.3%, p = 0.018). There was no data from the rest of African countries. We were unable to complete the meta-analysis of osteoporotic fractures due to the lack of available data.

CONCLUSION: This study revealed that the prevalence of GIOP varies significantly in Africa. There is no information, however, for most of Africa, and further prospective studies are needed to develop context-specific GIOP preventive strategies in patients with RMDs.

PMID:37129714 | DOI:10.1007/s11657-023-01246-6

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Nevin Manimala Statistics

Bayesian detection and tracking of odontocetes in 3-D from their echolocation clicks

J Acoust Soc Am. 2023 May 1;153(5):2690. doi: 10.1121/10.0017888.

ABSTRACT

Localization and tracking of marine animals can reveal key insights into their behaviors underwater that would otherwise remain unexplored. A promising nonintrusive approach to obtaining location information of marine animals is to process their bioacoustic signals, which are passively recorded using multiple hydrophones. In this paper, a data processing chain that automatically detects and tracks multiple odontocetes (toothed whales) in three dimensions (3-D) from their echolocation clicks recorded with volumetric hydrophone arrays is proposed. First, the time-difference-of-arrival (TDOA) measurements are extracted with a generalized cross-correlation that whitens the received acoustic signals based on the instrument noise statistics. Subsequently, odontocetes are tracked in the TDOA domain using a graph-based multi-target tracking (MTT) method to reject false TDOA measurements and close gaps of missed detections. The resulting TDOA estimates are then used by another graph-based MTT stage that estimates odontocete tracks in 3-D. The tracking capability of the proposed data processing chain is demonstrated on real acoustic data provided by two volumetric hydrophone arrays that recorded echolocation clicks from Cuvier’s beaked whales (Ziphius cavirostris). Simulation results show that the presented MTT method using 3-D can outperform an existing approach that relies on manual annotation.

PMID:37129673 | DOI:10.1121/10.0017888

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Prednisone vs Placebo and Live Birth in Patients With Recurrent Implantation Failure Undergoing In Vitro Fertilization: A Randomized Clinical Trial

JAMA. 2023 May 2;329(17):1460-1468. doi: 10.1001/jama.2023.5302.

ABSTRACT

IMPORTANCE: Implantation failure remains a critical barrier to in vitro fertilization. Prednisone, as an immune-regulatory agent, is widely used to improve the probability of implantation and pregnancy, although the evidence for efficacy is inadequate.

OBJECTIVE: To determine the efficacy of 10 mg of prednisone compared with placebo on live birth among women with recurrent implantation failure.

DESIGN, SETTING, AND PARTICIPANTS: A double-blind, placebo-controlled, randomized clinical trial conducted at 8 fertility centers in China. Eligible women who had a history of 2 or more unsuccessful embryo transfer cycles, were younger than 38 years when oocytes were retrieved, and were planning to undergo frozen-thawed embryo transfer with the availability of good-quality embryos were enrolled from November 2018 to August 2020 (final follow-up August 2021).

INTERVENTIONS: Participants were randomized (1:1) to receive oral pills containing either 10 mg of prednisone (n = 357) or matching placebo (n = 358) once daily, from the day at which they started endometrial preparation for frozen-thawed embryo transfer through early pregnancy.

MAIN OUTCOMES AND MEASURES: The primary outcome was live birth, defined as the delivery of any number of neonates born at 28 or more weeks’ gestation with signs of life.

RESULTS: Among 715 women randomized (mean age, 32 years), 714 (99.9%) had data available on live birth outcomes and were included in the primary analysis. Live birth occurred among 37.8% of women (135 of 357) in the prednisone group vs 38.8% of women (139 of 358) in the placebo group (absolute difference, -1.0% [95% CI, -8.1% to 6.1%]; relative ratio [RR], 0.97 [95% CI, 0.81 to 1.17]; P = .78). The rates of biochemical pregnancy loss were 17.3% in the prednisone group and 9.9% in the placebo group (absolute difference, 7.5% [95% CI, 0.6% to 14.3%]; RR, 1.75 [95% CI, 1.03 to 2.99]; P = .04). Of those in the prednisone group, preterm delivery occurred among 11.8% and of those in the placebo group, 5.5% of pregnancies (absolute difference, 6.3% [95% CI, 0.2% to 12.4%]; RR, 2.14 [95% CI, 1.00 to 4.58]; P = .04). There were no statistically significant between-group differences in the rates of biochemical pregnancy, clinical pregnancy, implantation, neonatal complications, congenital anomalies, other adverse events, or mean birthweights.

CONCLUSIONS AND RELEVANCE: Among patients with recurrent implantation failure, treatment with prednisone did not improve live birth rate compared with placebo. Data suggested that the use of prednisone may increase the risk of preterm delivery and biochemical pregnancy loss. Our results challenge the value of prednisone use in clinical practice for the treatment of recurrent implantation failure.

TRIAL REGISTRATION: Chinese Clinical Trial Registry Identifier: ChiCTR1800018783.

PMID:37129654 | DOI:10.1001/jama.2023.5302

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Systematic review and meta-analysis of mesenchymal stromal/stem cells as strategical means for the treatment of COVID-19

Ther Adv Respir Dis. 2023 Jan-Dec;17:17534666231158276. doi: 10.1177/17534666231158276.

ABSTRACT

BACKGROUND: In coronavirus disease 2019 (COVID-19) patients, elevated levels of inflammatory cytokines from over stimulation of immune cells have become a concern due to the potential outburst of cytokine storm that damages the tissues and organs, especially the lungs. This leads to the manifestation of COVID-19 symptoms, such as pneumonia, acute respiratory distress syndrome (ARDS), multiple organ failure, and eventually death. Mesenchymal stromal/stem cells (MSCs) are currently one of hopeful approaches in treating COVID-19 considering its anti-inflammatory and immunomodulatory functions. On that account, the number of clinical trials concerning the use of MSCs for COVID-19 has been increasing. However, the number of systematic reviews and meta-analysis that specifically discuss its potential as treatment for the disease is still lacking. Therefore, this review will assess the safety and efficacy of MSC administration in COVID-19 patients.

OBJECTIVES: To pool evidence on the safety and efficacy of MSCs in treating COVID-19 by observing MSC-related adverse effects as well as evaluating its effects in reducing inflammatory response and improving pulmonary function.

DATA SOURCES AND METHODS: Following literature search across six databases and one trial register, full-text retrieval, and screening against eligibility criteria, only eight studies were included for data extraction. All eight studies evaluated the use of umbilical cord-derived mesenchymal stromal/stem cell (UC-MSC), infused intravenously. Of these eight studies, six studies were included in meta-analysis on the incidence of mortality, adverse events (AEs), and serious adverse events (SAEs), and the levels of C-reactive protein (CRP) and interleukin (IL)-6. Meta-analysis on pulmonary function was not performed due to insufficient data.

RESULTS: MSC-treated group showed significantly lower risk of mortality than the control group (p = 0.03). No statistical significance was observed on the incidence of AEs (p = 0.78) and SAEs (p = 0.44), and the levels of CRP (p = 0.06) and IL-6 (p = 0.09).

CONCLUSION: MSCs were safe for use, with lower risk of mortality and no association with AEs. Regarding efficacy, descriptive analysis showed indications of improvement on the inflammatory reaction, lung clearance, and oxygenation status despite the lack of statistical significance in meta-analysis of CRP and IL-6. Nevertheless, more studies are needed for affirmation.

REGISTRATION: This systematic review and meta-analysis was registered on the PROSPERO database (no. CRD42022307730).

PMID:37128999 | DOI:10.1177/17534666231158276

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Psychological capital, grit and organizational justice as positive strengths and resources among registered nurses: A path analysis

Nurs Open. 2023 May 2. doi: 10.1002/nop2.1769. Online ahead of print.

ABSTRACT

AIM: To examine registered nurses’ individual strengths (psychological capital and grit) and an organizational resource (organizational justice) as well as associated work-related outcomes. In a time of a global nursing shortage, there is an urgent need to identify strengths and resources that can have a positive impact on the health, well-being and retention of registered nurses.

DESIGN: A cross-sectional survey.

METHODS: A nationwide convenience sample of 514 registered nurses responded to a survey. Data were collected using a self-reported questionnaire between March and May 2018. Data were analysed using descriptive statistics and multivariate path analysis.

RESULTS: Participants rated their psychological capital and grit moderately high. Grit and organizational justice were found to have significant direct effects on psychological capital. Furthermore, psychological capital had positive direct effects on engagement and the perception of well-conducted everyday nursing as well as negative direct effects on burnout, the stress of conscience and the intent to leave the profession.

CONCLUSION: The results suggest that nurse leaders and managers could consider improving registered nurses’ well-being with two complementary approaches. It might be useful to reinforce positive, individual strengths, such as psychological capital, and at the same time create more favourable nursing work environments, for example by strengthening organizational justice.

IMPLICATIONS FOR THE PROFESSION: Psychological capital and grit are emerging concepts in nursing workforce research. Identifying registered nurses’ positive strengths and resources is important for inventing interventions that enhance nurses’ engagement and well-being as well as reduce turnover intentions.

IMPACT: Nurse leaders and managers play crucial roles in managing and developing registered nurses’ individual strengths and organizational resources. This has gained even more importance now as the COVID-19 pandemic could have a long-term negative impact on nurses’ well-being.

REPORTING METHOD: The study is reported following STROBE guidelines.

PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

PMID:37128977 | DOI:10.1002/nop2.1769

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Incidence of postoperative delirium in older adults undergoing surgical procedures: A systematic literature review and meta-analysis

Worldviews Evid Based Nurs. 2023 May 2. doi: 10.1111/wvn.12649. Online ahead of print.

ABSTRACT

BACKGROUND: With the increase in life expectancy around the globe, the incidence of postoperative delirium (POD) among older people (≥65 years) is growing. Previous studies showed a wide variation in the incidence of POD, from 4% to 53%, with a lack of specific evidence about the incidence of POD by specific surgery type among older people. The aim of this systematic review and meta-analysis was to determine the incidence of POD by surgery type within populations 65 years and over.

METHODS: Databases including PubMed, Cochrane library, Embase, and CINAHL were searched until October 2020. Due to the relatively higher number of meta-analyses undertaken in this area of research, a streamlined systematic meta-analysis was proposed.

RESULTS: A total of 28 meta-analyses (comprising 284 individual studies) were reviewed. Data from relevant individual studies (n = 90) were extracted and included in the current study. Studies were grouped into eight surgery types and the incidence of POD for orthopedic, vascular, spinal, cardiac, colorectal, abdominal, urologic, and mixed surgeries was 20%, 14%, 13%, 32%, 14%, 30%, 10%, and 26%, respectively. POD detection instruments were different across the studies, with Confusion Assessment Method (CAM & CAM-ICU) being the most frequently adopted.

LINKING EVIDENCE TO ACTION: This study showed that POD incidence in older people undergoing surgery varied widely across surgery type. The more complex surgeries like cardiac and abdominal surgeries were associated with a higher risk of POD. This highlights the need to include the level of surgery complexity as a risk factor in preoperative assessments.

PMID:37128953 | DOI:10.1111/wvn.12649

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Fertility desires of antiretroviral therapy-attending HIV-positive women and its associated factors in Harari region, Ethiopia

Int Health. 2023 May 2:ihad030. doi: 10.1093/inthealth/ihad030. Online ahead of print.

ABSTRACT

BACKGROUND: The desire to have children among mothers living with HIV remains a serious public health issue in nations with low coverage for antiretroviral therapy and the prevention of mother-to-child transmission, even if it is feasible to have an HIV-negative child. Therefore, this study aimed to assess fertility desire and associated factors among antiretroviral therapy-attending HIV-positive women at Hiwot Fana Specialized University Hospital, in Harari, Ethiopia.

METHODS: A facility-based cross-sectional study design was employed among 639 anti retro-viral therapy attending HIV – positive women by systematic random sampling method selected from June 15 to November 30, 2020. A binary logistic regression model was fitted to identify the associated factors with fertility desire. Descriptive results were presented in percentages, whereas analytical results were reported in adjusted ORs (AORs) with a 95% CI. At p=0.05, statistical significance was declared.

RESULTS: A total of 639 participants were included in the study; 69.5%(95% CI 65.7 to 72.9%) of the participants had fertility desire. Younger age (<35 years) (AOR=2.35, 95% CI 1.27 to 4.35), married women (AOR=3.02, 95% CI 1.32 to 12.25), childless women (AOR=2.86, 95% CI 1.17 to 4.82) and women whose duration of HIV diagnosis was ≤5 years (AOR=0.41, 95% CI 0.20 to 0.71) were significantly associated with fertility desire.

CONCLUSION: The majority of the study participants have a desire to have children. In light of the high prevalence of fertility desire among antiretroviral therapy-attending HIV-positive women, it is recommended to counsel younger women on reproductive planning and encourage partner testing.

PMID:37128936 | DOI:10.1093/inthealth/ihad030