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Nevin Manimala Statistics

Lessons learned after the disruption caused by COVID-19 in the management of urolithiasis: An example of adaptation in a high-volume center

Actas Urol Esp (Engl Ed). 2022 Aug 4:S2173-5786(22)00078-6. doi: 10.1016/j.acuroe.2022.08.003. Online ahead of print.

ABSTRACT

BACKGROUND: The aim was to determine the impact of COVID-19 pandemic on urolithiasis presentation and management.

METHODS: In this retrospective study, we comparatively evaluated urgent and elective procedures due to urolithiasis during the early eight months of the COVID-19 pandemic (March 1, 2020, to October 31, 2020) compared to the same period a year before, and between waves. The student’s t-test, chi-square test, Mann-Whitney U test and Fisher’s exact test were used to compare the patients’ characteristics and outcomes between the two periods and waves.

RESULTS: Five hundred and thirty procedures were included. The overall numbers of surgical procedures due to urolithiasis were similar between pre-pandemic and pandemic periods. Regarding elective surgery, our data draw attention to the increased complication rate in the pandemic times, but no statistically significant differences in terms of types of procedures and need for complementary treatments were observed. We noted that patterns of presentation of complicated renal colic were different during COVID-19 pandemic, with a higher number of days after the onset of symptoms and a higher proportion of patients presenting acute kidney injury. Furthermore, a significant increase of creatinine levels at presentation in first wave was detected, and a growth in the number of urgent procedures after the first wave was noted, owing to the delay in urolithiasis treatment and diagnosis.

CONCLUSION: The COVID-19 pandemic has negatively affected both urgent and elective management of urolithiasis. Lessons about the management of urolithiasis in this context should be learned to avoid fatal complications and improve standards of care.

PMID:36334974 | DOI:10.1016/j.acuroe.2022.08.003

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Nevin Manimala Statistics

Young Age on Starting Prostate-specific Antigen Testing Is Associated with a Greater Reduction in Prostate Cancer Mortality: 24-Year Follow-up of the Göteborg Randomized Population-based Prostate Cancer Screening Trial

Eur Urol. 2022 Nov 2:S0302-2838(22)02715-4. doi: 10.1016/j.eururo.2022.10.006. Online ahead of print.

ABSTRACT

BACKGROUND: The risk of death from prostate cancer (PC) depends on age, but the age at which to start prostate-specific antigen (PSA) screening remains uncertain.

OBJECTIVE: To study the relationship between risk reduction for PC mortality and age at first PSA screening.

DESIGN, SETTING, AND PARTICIPANTS: The randomized Göteborg-1 trial invited men for biennial PSA screening between the ages of 50 and 70 yr (screening, n = 10 000) or no invitation but exposure to opportunistic PSA testing (control, n = 10 000).

INTERVENTION: Regular versus opportunistic PSA screening or no PSA.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We modeled the nonlinear association between starting age and the absolute risk reduction in PC mortality in three settings: (1) intention-to-screen (randomized arms); (2) historical control (screening group and 1990-1994 registry data); and (3) attendees only (screening attendees and matched controls). We tested whether the effect of screening on PC mortality depends on the age at starting screening by comparing survival models with and without an interaction between trial arm and age (intention-to-screen and attendees only).

RESULTS AND LIMITATIONS: Younger age on starting PSA testing was associated with a greater reduction in PC mortality. Starting screening at age 55 yr approximately halved the risk of PC death compared to first PSA at age 60 yr. The test of association between starting age and the effect of screening on PC mortality was slightly greater than the conventional level of statistical significance (p = 0.052) for the entire cohort, and statistically significant among attendees (p = 0.002). This study is limited by the low number of disease-specific deaths for men starting screening before age 55 yr and the difficulty in discriminating between the effect of starting age and screening duration.

CONCLUSIONS: Given that prior screening trials included men aged up to 70 yr on starting screening, our results suggest that the effect size reported in prior trials underestimates that of currently recommended programs starting at age 50-55 yr.

PATIENT SUMMARY: In this study from the Göteborg-1 trial, we looked at the effect of prostate-specific antigen (PSA) screening in reducing men’s risk of dying from prostate cancer given the age at which they begin testing. Starting at a younger age reduced the risk of prostate cancer death by a greater amount. We recommend that PSA screening should start no later than at age 55 yr.

PMID:36334968 | DOI:10.1016/j.eururo.2022.10.006

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Nevin Manimala Statistics

Comparative Study of 2 Extended-Release Tacrolimus Formulations in Kidney Transplantation

Transplant Proc. 2022 Nov 2:S0041-1345(22)00659-5. doi: 10.1016/j.transproceed.2022.10.001. Online ahead of print.

ABSTRACT

BACKGROUND: During the 1900s, tacrolimus became the mainstay immunosuppressive agent to prevent rejection after kidney transplant. Subsequently, an extended-release tacrolimus (ER-Tac) formulation was developed to improve adherence, and its generic version has been marketed over the last years. This study examines the differences in efficacy and safety between the generic ER-Tac (Conferoport) and the reference brand-name drug (Advagraf).

METHODS: Prospective, randomized and parallel single-center study (May 2020 to June 2021) with 52 kidney transplant recipients who were randomly assigned to 1 of the following groups: study group (Conferoport, n = 31) and control group (Advagraf, n = 21). The variables of interest were collected and analyzed to compare tacrolimus efficacy and safety between them. Demographic characteristics of the patients and clinical donor data were homogeneous in both groups (P > .05).

RESULTS: No statistically significant differences were found among treatments regarding dosage used, levels, creatinine, and proteinuria (P > .05), with these variables presenting a downward trend during follow-up and, consequently, the improvement of graft function. Analyses also revealed the absence of differences concerning the incidence of acute rejection and intrapatient variability (coefficient of variation) throughout the first year of evolution between both formulations (P > .05). A total of 5 graft losses occurred, 2 resulting from patient death.

CONCLUSIONS: In our experience, we found no significant differences between the measured parameters in relation to the efficacy and safety profile of both drugs, with generic ER-Tac being an alternative comparable with the reference brand-name ER-Tac.

PMID:36334963 | DOI:10.1016/j.transproceed.2022.10.001

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Nevin Manimala Statistics

Three families of automated text analysis

Soc Sci Res. 2022 Nov;108:102798. doi: 10.1016/j.ssresearch.2022.102798. Epub 2022 Oct 1.

ABSTRACT

Since the beginning of this millennium, data in the form of human-generated text in a machine-readable format has become increasingly available to social scientists, presenting a unique window into social life. However, harnessing vast quantities of this highly unstructured data in a systematic way presents a unique combination of analytical and methodological challenges. Luckily, our understanding of how to overcome these challenges has also developed greatly over this same period. In this article, I present a novel typology of the methods social scientists have used to analyze text data at scale in the interest of testing and developing social theory. I describe three “families” of methods: analyses of (1) term frequency, (2) document structure, and (3) semantic similarity. For each family of methods, I discuss their logical and statistical foundations, analytical strengths and weaknesses, as well as prominent variants and applications.

PMID:36334926 | DOI:10.1016/j.ssresearch.2022.102798

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Nevin Manimala Statistics

Researcher reasoning meets computational capacity: Machine learning for social science

Soc Sci Res. 2022 Nov;108:102807. doi: 10.1016/j.ssresearch.2022.102807. Epub 2022 Oct 29.

ABSTRACT

Computational power and big data have created new opportunities to explore and understand the social world. A special synergy is possible when social scientists combine human attention to certain aspects of the problem with the power of algorithms to automate other aspects of the problem. We review selected exemplary applications where machine learning amplifies researcher coding, summarizes complex data, relaxes statistical assumptions, and targets researcher attention to further social science research. We aim to reduce perceived barriers to machine learning by summarizing several fundamental building blocks and their grounding in classical statistics. We present a few guiding principles and promising approaches where we see particular potential for machine learning to transform social science inquiry. We conclude that machine learning tools are increasingly accessible, worthy of attention, and ready to yield new discoveries for social research.

PMID:36334925 | DOI:10.1016/j.ssresearch.2022.102807

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Nevin Manimala Statistics

Plasma extracellular vesicle SerpinG1 and CD14 levels are associated with MACE and MALE in patients undergoing femoral endarterectomy

Eur J Vasc Endovasc Surg. 2022 Nov 2:S1078-5884(22)00729-8. doi: 10.1016/j.ejvs.2022.10.045. Online ahead of print.

ABSTRACT

OBJECTIVES AND DESIGN: Plasma extracellular vesicles (EV) are an emerging source of biomarkers for diagnosis and prognosis of cardiovascular disease (CVD). Risk stratification for common adverse events such as Major Adverse Limb Event (MALE) and Major Adverse Cardiovascular Events (MACE) by an EV blood sample could improve healthcare management by individualizing drug therapy or by improving informed decision-making regarding revascularisations in patients with PAD. As such, we investigated the associations of plasma EV proteins with prospectively registered MALE and MACE in consecutive patients undergoing femoral endarterectomy.

METHODS: Using the Athero-Express biobank study, we measured four EV proteins (Cystatin C, CD14, Serpin C1 and Serpin G1) in the HDL subfraction isolated from plasma of 317 PAD patients undergoing arterial revascularization. Multivariable Cox proportional hazard regression was used to investigate the association between plasma EV-protein levels with MACE and MALE, in the three-year postoperative period.

RESULTS: Most patients were treated for claudication (Fontaine II, 52.8%), although rest pain (Fontaine III, 30.1%) and ischemic wounds (Fontaine IV, 17.1%) were common in this cohort. Within three years, 51 patients died of which 25 due to CVD, 39 patients experienced a MACE, and 125 patients experienced a MALE. Multivariable regression models, based on statistically proven covariables and on literature, showed a significant association of Serpin G1 (HR 1.49 (95% CI 1.08 – 2.06) P = .016) and CD14 (HR 1.40 (1.03-1.90) P = .029) with MACE, and of Serpin G1 (HR 1.29 (1.07 – 1.57) P = .009) with MALE.

CONCLUSIONS: Serpin G1 and CD14 plasma EV protein levels are associated with future MACE and MALE in patients with severe PAD.

PMID:36334903 | DOI:10.1016/j.ejvs.2022.10.045

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Nevin Manimala Statistics

Comparison of outcomes for major contemporary endograft devices used for endovascular repair of intact abdominal aortic aneurysms

Eur J Vasc Endovasc Surg. 2022 Nov 2:S1078-5884(22)00732-8. doi: 10.1016/j.ejvs.2022.11.005. Online ahead of print.

ABSTRACT

OBJECTIVE: To compare rates of mortality, rupture and secondary intervention following endovascular repair (EVAR) of intact abdominal aortic aneurysms (AAA) using contemporary endograft devices from three major manufacturers.

DESIGN: Retrospective cohort study using linked clinical registry (Australasian Vascular Audit) and all payer administrative data.

METHODS: We identified patients undergoing EVAR for intact AAA between 2010-2019 in New South Wales, Australia. We compared rates of all-cause mortality, secondary rupture and secondary intervention (subsequent aneurysm repair; other secondary aortic intervention) for patients treated with Cook, Medtronic and Gore standard devices. We used inverse probability of treatment weighted proportional hazards and competing risk regression to adjust for patient, clinical and aneurysm characteristics, using Cook as the referent device.

RESULTS: We identified 2,874 eligible EVAR patients, with a median follow-up of 4.1 (maximum 9.5) years. Mortality rates were similar for patients receiving different devices (ranging between 7.0-7.3 per 100 person-years). There was no significant difference between devices in secondary rupture rates, which ranged between 0.4-0.5 per 100 person-years. Patients receiving Medtronic and Gore devices tended to have higher crude rates of subsequent aneurysm repair (1.5 per 100 person-years) than patients receiving Cook devices (0.8 per 100 person-years). This finding remained in the adjusted analysis, but was only statistically significant for Medtronic devices (HR 1.57, 95% CI 1.02-2.47; HR 1.73, 95% CI 0.94-3.18 respectively).

CONCLUSION: Major endograft devices have similar overall long-term safety profiles. However, there may be differences in rates of secondary intervention for some devices. This may reflect endograft durability, or patient selection for different devices based on aneurysm anatomy. Continuous comparative assessments are needed to guide evidence for treatment decisions across the range of available devices.

PMID:36334901 | DOI:10.1016/j.ejvs.2022.11.005

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Nevin Manimala Statistics

Peripheral double negative T: A look at senescent Cubans

Exp Gerontol. 2022 Nov 2:112006. doi: 10.1016/j.exger.2022.112006. Online ahead of print.

ABSTRACT

INTRODUCTION: Age-related changes in the immune system are called immunosenescence. Within the T lymphocytes is the subpopulation of double negative (DNT) peripheral lymphocytes that are immunomodulators of the immune response, based on their ability to suppress the functions of simple positive T cells and their cytotoxicity for tumor cells and those infected by viruses.

OBJECTIVE: To determine the frequency of peripheral DNT lymphocytes in older Cuban adults.

METHODS: A cross-sectional study was carried out in 30 older adults, residents in Cuba. DNT lymphocytes in peripheral blood were quantified by flow cytometry. A Beckman Coulter Gallios flow cytometer was used for data reading and analysis. Percentage values mean and standard deviation were used. The Chi-square was used to relate the percentage values of DNT and comorbidities. It was considered statistically significant if p ≤ 0.05.

RESULTS: There was a predominance of women who represented 70 %. No older adult with low values of DNT lymphocytes was reported. Women with high percentage and absolute values of DNT lymphocytes prevailed in relation to men. In the group ≥80 years, high values in % and absolute values of DNT lymphocytes predominated. The high percentage values of DNT cells were mainly related to cardiovascular disease, and predominated in the elderly of ≥80 years old; who presented respiratory and skin infections, fundamentally. The percentage normal value in the group < 80 years was significant (p = 0.0198). The Chi-square value was 0,5995.

CONCLUSIONS: Most older adults who exhibited high percentage and absolute values of DNT lymphocytes, or a tendency to them, had some associated comorbidity, an idea that suggests that DNT cells participate in immune surveillance, defense and homeostasis based on their double identity, that is, its pathogenic or immunosuppressive phenotype according to the specific immunological microenvironment.

PMID:36334893 | DOI:10.1016/j.exger.2022.112006

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Nevin Manimala Statistics

Hip MR arthrography using normal saline is less accurate than using a gadolinium-based contrast agent

Arthroscopy. 2022 Nov 2:S0749-8063(22)00694-6. doi: 10.1016/j.arthro.2022.10.036. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the diagnostic performance of hip magnetic resonance (MR) arthrography with a gadolinium-based contrast agent (GBCA) or normal saline (NS) for intra-articular pathologies.

METHODS: This retrospective study was approved by the institutional review board of our hospital, and the requirement for informed consent was waived. The study included 37 consecutive patients (38 hips; 21 right hips; 24 males; mean age, 33 years) who underwent GBCA-hip MR arthrography from July 2011 to January 2020 and 30 consecutive patients (30 hips; 20 right hips; 21 males; mean age, 40 years) who underwent NS-hip MR arthrography from January 2018 to June 2020. All images were evaluated twice independently by two radiologists blinded to the arthroscopic findings for the presence of labral tears, cartilage abnormalities, or ligamentum teres tears. Intra- and inter-reader reliabilities were determined by kappa values (k) using the Chi-squared test, and diagnostic performance was evaluated based on the arthroscopic findings. A p-value less than 0.05 was considered to indicate statistical significance.

RESULTS: Intra-reader reliability in the detection of intra-articular pathologies ranged from moderate to almost perfect (k =0.510-0.840) and inter-reader reliability ranged from moderate to substantial (k =0.441-0.695) for GBCA- and NS-hip MR arthrography. The diagnostic accuracy of GBCA- and NS-hip MR arthrography was as follows: 81.6-92.1% and 66.7-73.3% for labral tears, respectively; 68.4-86.8% and 63.3-70.0% for cartilage abnormality, respectively; and 68.4-76.3% and 50.0-56.7% for ligamentum teres tears, respectively.

CONCLUSION: NS-hip MR arthrography may be less accurate than GBCA-hip MR arthrography.

LEVEL OF EVIDENCE: Level II of Development of diagnostic criteria (consecutive patients with consistently applied reference standard and blinding).

PMID:36334855 | DOI:10.1016/j.arthro.2022.10.036

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Nevin Manimala Statistics

Regional oxygen saturation measured by two different oximetry monitors in infants and children undergoing living donor liver transplantation with bilirubin measurements: A prospective observational study

Paediatr Anaesth. 2022 Nov 5. doi: 10.1111/pan.14597. Online ahead of print.

ABSTRACT

BACKGROUND: Tissue oximetry devices use wavelengths in the 680-870 nm range to separate between oxygenated/deoxygenated hemoglobin (Hb). Conjugated bilirubin has an absorption peak at 730 nm.

AIMS: We hypothesized that ForeSight Elite using 5 wavelengths reduces interference from bilirubin and shows higher regional tissue oxygen saturation (rSO2 ) than INVOS 5100C incorporating 2 wavelengths.

METHODS: Infants and children undergoing living donor liver transplantation were included between March 2019 and September 2020. Cerebral and somatic rSO2 were measured and real-time simultaneous data were collected. Additionally, measurements were collected at 1) Baseline 2) Beginning of dissection phase 3) Beginning of anhepatic phase 4) Reperfusion phase 5) Skin closure. Bilirubin level was available at baseline and at reperfusion. Hyperbilirubinemia was defined as bilirubin level ≥1.0 mg/dl.

RESULTS: Thirty-three patients with median age of 27 months and median weight of 12 kg were included. Baseline bilirubin levels were higher compared to values at reperfusion (P=0.021). A linear mixed effects model considering bilirubin as fixed and patient as random effect showed that there was a statistically significant difference in cerebral rSO2 readings in function of time (P=0.031), device (P< 0.001) and bilirubin concentrations (P=0.007) but not for Hb (P=0.347), SpO2 (P=0.882) and arterial partial pressure of CO2 (PaCO2 ) (P=0.146). The model showed that there was a statistically significant difference in somatic rSO2 readings in function of device (P< 0.001) and bilirubin concentrations (P=0.023) but not for time (P=0.074), Hb (P=0.954), SpO2 (P=0.108) and PaCO2 (P=0.775). Bland-Altman plot analyzing cerebral and somatic rSO2 between both devices showed respectively a mean absolute Bias and 95% limits of agreement of 21.73% (-10.21 to 53.67) and 19.52% (-29.51 to 68.54).

CONCLUSIONS: Oximetry devices emitting light at > 2 wavelengths may overcome interference from hyperbilirubinemia providing higher rSO2 readings.

PMID:36334305 | DOI:10.1111/pan.14597