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Nevin Manimala Statistics

Use of dried blood spots for monitoring inflammatory and nutritional biomarkers in the elderly

Clin Chem Lab Med. 2023 Nov 24. doi: 10.1515/cclm-2023-0312. Online ahead of print.

ABSTRACT

OBJECTIVES: Blood microsampling, particularly dried blood spots (DBSs), is an attractive minimally-invasive approach that is well suited for home sampling and predictive medicine associated with longitudinal follow-up of the elderly. However, in vitro diagnostic quantification of biomarkers from DBS poses a major challenge. Clinical mass spectrometry can reliably quantify blood proteins in various research projects. Our goal here was to use mass spectrometry of DBS in a real-world clinical setting and compared it to the standard immunoassay method. We also sought to correlate DBS mass spectrometry measurements with clinical indices.

METHODS: A clinical trial of diagnostic equivalence was conducted to compare conventional venous samples quantified by immunoassay and DBSs quantified by mass spectrometry in an elderly population. We assayed three protein biomarkers of nutritional and inflammatory status: prealbumin (transthyretin), C-reactive protein, and transferrin.

RESULTS: The analysis of DBSs showed satisfactory variability and low detection limits. Statistical analysis confirmed that the two methods give comparable results at clinical levels of accuracy. In conclusion, we demonstrated, in a real-life setting, that DBSs can be used to measure prealbumin, CRP and transferrin, which are commonly used markers of nutritional status and inflammation in the elderly. However, there was no correlation with patient frailty for these proteins.

CONCLUSIONS: Early detection and regular monitoring of nutritional and inflammatory problems using DBS appear to be clinically feasible. This could help resolve major public health challenges in the elderly for whom frailty leads to serious risks of health complications.

PMID:37999931 | DOI:10.1515/cclm-2023-0312

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Nevin Manimala Statistics

A model for managing quality control for a network of clinical chemistry instruments measuring the same analyte

Clin Chem Lab Med. 2023 Nov 24. doi: 10.1515/cclm-2023-0965. Online ahead of print.

ABSTRACT

OBJECTIVES: Monitoring quality control for a laboratory or network with multiple instruments measuring the same analyte is challenging. We present a retrospective assessment of a method to detect medically significant out-of-control error conditions across a group of instruments measuring the same analyte. The purpose of the model was to ensure that results from any of several instruments measuring the same analytes in a laboratory or a network of laboratories provide comparable results and reduce patient risk. Limited literature has described how to manage QC in these very common situations.

METHODS: Single Levey-Jennings control charts were designed using peer group target mean and control limits for five common clinical chemistry analytes in a network of eight analyzers in two different geographical sites. The QC rules used were 13s/22s/R4s, with the mean being a peer group mean derived from a large population of the same instrument and the same QC batch mean and a group CV. The peer group data used to set the target means and limits were from a quality assurance program supplied by the instrument supplier. Both statistical and clinical assessments of significance were used to evaluate QC failure. Instrument bias was continually monitored.

RESULTS: It was demonstrated that the biases of each instrument were not statistically or clinically different compared to the peer group’s average over six months from February 2023 until July 2023. Over this period, the error rate determined by the QC model was consistent with statistical expectations for the 13s/22s/R4s rule. There were no external quality assurance failures, and no detected error exceeded the TEa (medical impact). Thus, the combined statistical/clinical assessment reduced unnecessary recalibrations and the need to amend results.

CONCLUSIONS: This paper describes the successful implementation of a quality control model for monitoring a network of instruments, measuring the same analytes and using externally provided quality control targets. The model continually assesses individual instrument bias and imprecision while ensuring all instruments in the network meet clinical goals for quality. The focus of this approach is on detecting medically significant out-of-control error conditions.

PMID:37999926 | DOI:10.1515/cclm-2023-0965

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Nevin Manimala Statistics

Evaluating the Performance of Different Large Language Models on Health Consultation and Patient Education in Urolithiasis

J Med Syst. 2023 Nov 24;47(1):125. doi: 10.1007/s10916-023-02021-3.

ABSTRACT

OBJECTIVES: To evaluate the effectiveness of four large language models (LLMs) (Claude, Bard, ChatGPT4, and New Bing) that have large user bases and significant social attention, in the context of medical consultation and patient education in urolithiasis.

MATERIALS AND METHODS: In this study, we developed a questionnaire consisting of 21 questions and 2 clinical scenarios related to urolithiasis. Subsequently, clinical consultations were simulated for each of the four models to assess their responses to the questions. Urolithiasis experts then evaluated the model responses in terms of accuracy, comprehensiveness, ease of understanding, human care, and clinical case analysis ability based on a predesigned 5-point Likert scale. Visualization and statistical analyses were then employed to compare the four models and evaluate their performance.

RESULTS: All models yielded satisfying performance, except for Bard, who failed to provide a valid response to Question 13. Claude consistently scored the highest in all dimensions compared with the other three models. ChatGPT4 ranked second in accuracy, with a relatively stable output across multiple tests, but shortcomings were observed in empathy and human caring. Bard exhibited the lowest accuracy and overall performance. Claude and ChatGPT4 both had a high capacity to analyze clinical cases of urolithiasis. Overall, Claude emerged as the best performer in urolithiasis consultations and education.

CONCLUSION: Claude demonstrated superior performance compared with the other three in urolithiasis consultation and education. This study highlights the remarkable potential of LLMs in medical health consultations and patient education, although professional review, further evaluation, and modifications are still required.

PMID:37999899 | DOI:10.1007/s10916-023-02021-3

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Nevin Manimala Statistics

Plasma metabolomics reveals the intervention mechanism of different types of exercise on chronic unpredictable mild stress-induced depression rat model

Metab Brain Dis. 2023 Nov 24. doi: 10.1007/s11011-023-01310-7. Online ahead of print.

ABSTRACT

To study the effects of different types of exercise on the plasma metabolomics of chronic unpredictable mild stress (CUMS)-induced depressed rats based on 1H-NMR metabolomics techniques, and to explore the potential mechanisms of exercise for the treatment of depression. Rats were randomly divided into blank control group (C), CUMS control group (D), pre-exercise with CUMS group (P), CUMS with aerobic exercise group, CUMS with resistance exercise group (R), and CUMS with aerobic + resistance exercise group (E). The corresponding protocol intervention was applied to each group of rats. Body weight, sucrose preference and open field tests were performed weekly during the experiment to evaluate the extent of depression in rats. Plasma samples from each group of rats were collected at the end of the experiment, and then the plasma was analyzed by 1H-NMR metabolomics combined with multivariate statistical analysis methods to identify differential metabolites and perform metabolic pathway analysis. (1) Compared with the group D, the body weight, sucrose preference rate, and the number of crossings and standings in the different types of exercise groups were significantly improved (p < 0.05 or p < 0.01). (2) Compared to group C, a total of 15 differential metabolites associated with depression were screened in the plasma of rats in group D, involving 6 metabolic pathways. Group P can regulate the levels of 6 metabolites: valine, lactate, inositol, glucose, phosphocreatine, acetoacetic acid. Group A can regulate the levels of 6 metabolites: N-acetylglycoprotein, leucine, lactate, low density lipoprotein, glucose and acetoacetic acid. Group R can regulate the levels of 6 metabolites: choline, lactate, inositol, glucose, phosphocreatine and acetoacetic acid. Group E can regulate the levels of 5 metabolites: choline, citric acid, glucose, acetone and acetoacetic acid. The different types of exercise groups can improve the depressive symptoms in CUMS rats, and there are common metabolites and metabolic pathways for their mechanism of effects. This study provides a powerful analytical tool to study the mechanism of the antidepressant effect of exercise, and provides an important method and basis for the early diagnosis, prevention and treatment of depression.

PMID:37999885 | DOI:10.1007/s11011-023-01310-7

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Nevin Manimala Statistics

Long-Term Treatment Over 52 Weeks with Monthly Fremanezumab in Drug-Resistant Migraine: A Prospective Multicenter Cohort Study

CNS Drugs. 2023 Nov 24. doi: 10.1007/s40263-023-01050-3. Online ahead of print.

ABSTRACT

BACKGROUND: Real-world studies on fremanezumab, an anti-calcitonin gene-related peptide monoclonal antibody for migraine prevention, are few and with limited follow-up.

OBJECTIVE: We aimed to evaluate the long-term (up to 52 weeks) effectiveness and tolerability of fremanezumab in high-frequency episodic migraine and chronic migraine.

METHODS: This s an independent, prospective, multicenter cohort study enrolling outpatients in 17 Italian Headache Centers with high-frequency episodic migraine or chronic migraine and multiple preventive treatment failures. Patients were treated with fremanezumab 225 mg monthly. The primary outcomes included changes from baseline (1 month before treatment) in monthly headache days, response rates (reduction in monthly headache days from baseline), and persistence in medication overuse at months 3, 6, and 12 (all outcome timeframes refer to the stated month). Secondary outcomes included changes from baseline in acute medication intake and disability questionnaires scores at the same timepoints. A last observation carried forward analysis was also performed.

RESULTS: A total of 90 patients who received at least one dose of fremanezumab and with a potential 12-month follow-up were included. Among them, 15 (18.0%) patients discontinued treatment for the entire population, a reduction in monthly headache days compared with baseline was reported at month 3, with a significant median [interquartile range] reduction in monthly headache days (- 9.0 [11.5], p < 0.001). A statistically different reduction was also reported at month 6 compared with baseline (- 10.0 [12.0]; p < 0.001) and at 12 months of treatment (- 10.0 [14.0]; p < 0.001). The percentage of patients with medication overuse was significantly reduced compared with baseline from 68.7% (57/83) to 29.6% (24/81), 25.3% (19/75), and 14.7% (10/68) at 3, 6, and 12 months of treatment, respectively (p < 0.001). Acute medication use (days and total number) and disability scores were also significantly reduced (p < 0.001). A ≥ 50% response rate was achieved for 51.9, 67.9, and 76.5% of all patients at 3, 6, and 12 months, respectively. Last observation carried forward analyses confirmed these findings. Fremanezumab was well tolerated, with just one patient discontinuing treatment because of adverse events.

CONCLUSIONS: This study provides evidence for the real-world effectiveness of fremanezumab in treating both high-frequency episodic migraine and chronic migraine, with meaningful and sustained improvements in multiple migraine-related variables. No new safety issue was identified.

PMID:37999868 | DOI:10.1007/s40263-023-01050-3

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Nevin Manimala Statistics

Health-related quality of life in long-term early-stage breast cancer survivors compared to general population in Korea

J Cancer Surviv. 2023 Nov 24. doi: 10.1007/s11764-023-01482-2. Online ahead of print.

ABSTRACT

PURPOSE: This study assessed health-related quality of life (HRQoL) of long-term breast cancer (BC) survivors diagnosed at early stages and compare with cancer-free, age-matched women.

METHODS: The study population included BC survivors diagnosed with ductal carcinoma in situ (DCIS) or breast cancer stages I-II, who had undergone lumpectomy/mastectomy, with time since diagnosis ranging from 9 to 16 years. Survey was conducted at two tertiary hospitals in 2020. Data for cancer-free female controls was randomly drawn from a population-based survey and age-, education-matched with 1 case: 3 controls ratio. Self-reported HRQoL was assessed using EQ-5D with five dimentions. EQ-5D utility index score was calculated. Difference in EQ-5D score was evaluated using the Tobit regression model with adjustment for other covariates.

RESULTS: Of 273 survivors. 88% and 12% underwent mastectomy and lumpectomy, respectively. The mean (standard deviation, SD) age at survey was 57.3 (8.5) years old. BC survivors reported significantly more problems performing daily activities (11% vs. 5%, p < 0.001), pain/discomfort (46% vs. 23%, p < 0.001), and anxious/depressed feelings (44% vs. 8%, p < 0.001) relative to the controls. Difference in EQ-5D score between BC survivors and the general population was higher in older age groups. The overall EQ-5D score of BC survivors was statistically lower than that of the control subjects (adjusted [Formula: see text]=0.117, p < 0.001).

CONCLUSION: Long-term BC survivors who survived beyond ten years post-diagnosis experience more pain, anxiety, and distress, leading to an overall poorer HRQoL.

IMPLICATIONS FOR CANCER SURVIVORS: This study suggest the importance of follow-up care, particularly focusing on pain, anxiety, and distress management to enhance the HRQoL of long-term BC survivors.

PMID:37999857 | DOI:10.1007/s11764-023-01482-2

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Nevin Manimala Statistics

Passive air sampling of VOCs, O3, NO2, and SO2 in the large industrial city of Ulsan, South Korea: spatial-temporal variations, source identification, and ozone formation potential

Environ Sci Pollut Res Int. 2023 Nov 24. doi: 10.1007/s11356-023-31109-z. Online ahead of print.

ABSTRACT

Concerns about volatile organic compounds (VOCs) have increased due to their toxicity and secondary reaction with nitrogen oxides (NOX) to form ozone (O3). In this study, passive air sampling of VOCs, O3, NO2, and SO2 was conducted in summer, fall, winter, and spring from 2019 to 2020 at six industrial and ten urban sites in Ulsan, the largest industrial city in South Korea. Over the entire sampling period, the concentration of toluene (mean: 8.75 μg/m3) was the highest of the 50 target VOCs, followed by m,p-xylenes (4.52 μg/m3), ethylbenzene (4.48 μg/m3), 3-methylpentane (4.40 μg/m3), and n-octane (4.26 μg/m3). Total (Σ50) VOC levels did not statistically differ between seasons, indicating that large amounts of VOCs are emitted into the atmosphere throughout the year. On the other hand, O3, NO2, and SO2 exhibited strong seasonal variation depending on the meteorological conditions and emission sources. The spatial distribution of Σ50 VOCs, NO2, and SO2 indicated that industrial complexes were major sources in Ulsan, while O3 had the opposite spatial distribution. Using a positive matrix factorization model, five major sources were identified, with industrial effects dominant. Aromatic compounds, such as m,p,o-xylenes, toluene, and 1,2,4-trimethylbenzene, significantly contributed to O3 formation. The VOC/NO2 ratio and O3 concentrations suggested that reducing VOC emissions is more effective than reducing NO2 emissions in terms of preventing the secondary formation of O3. The findings of this study allow for a better understanding of the relationship between VOCs, O3, NO2, and SO2 in industrial cities.

PMID:37999843 | DOI:10.1007/s11356-023-31109-z

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Nevin Manimala Statistics

Comparison of Efficacy and Safety Between Drug-Coated Balloons Versus Drug-Eluting Stents in the Treatment of De Novo Coronary Lesions in Large Vessels: A Study-Level Meta-Analysis of Randomized Control Trials

Cardiovasc Drugs Ther. 2023 Nov 24. doi: 10.1007/s10557-023-07526-0. Online ahead of print.

ABSTRACT

BACKGROUND: Drug-coated balloons (DCB) can be used as an alternative to drug-eluting stents (DES) in patients with de novo small vessel coronary artery disease. This study aims to assess the efficacy and safety of solely using DCB versus DES in percutaneous coronary intervention (PCI) for de novo coronary lesions in large vessels.

METHOD: A database search was conducted using PubMed, EMBASE, Cochrane Library, and http://Clinicaltrials.gov for trials comparing DCB only with DES in treating de novo coronary lesions in large vessels. Efficacy outcomes included coronary angiography (CAG), follow-up minimal lumen diameter (MLD), and late luminal loss (LLL). Safety outcomes included target lesion failure [TLF: cardiac death, myocardial infarction (MI), target lesion revascularization (TLR)] and their individual components.

RESULTS: We included seven randomized control trials (RCTs) with 816 patients, of which 422 and 394 patients were in the DCB and DES groups, respectively. MLD measured during the 6-12 months follow-up in the DCB group was statistically significantly smaller than in the DES group (MD -0.21, 95% CI -0.34 to -0.07, P = 0.003, I2 = 52%). LLL measured at 6-12 months follow-up was statistically significantly lower in the DCB group than in the DES group (MD -0.13, 95% CI -0.22 to -0.05, P = 0.003, I2 = 60%). TLF, cardiac death, MI, and TLR, were not statistically significantly different between the two groups.

CONCLUSION: Use of DCB was associated with less LLL at 6-12 months than DES and was not associated with any increase in adverse clinical events. This data suggests DCB are as effective in treating de novo coronary lesions in large vessels as DES.

PMID:37999833 | DOI:10.1007/s10557-023-07526-0

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Nevin Manimala Statistics

Causal relationship between depression and aging: a bidirectional two-sample Mendelian randomization study

Aging Clin Exp Res. 2023 Nov 24. doi: 10.1007/s40520-023-02596-4. Online ahead of print.

ABSTRACT

BACKGROUND: The causal relationship and the direction of the effect between depression and aging remain controversial.

METHODS: We used a bidirectional two-sample Mendelian randomization analysis to examine the relationship between depression and age proxy indicators. We obtained pooled statistics from genome-wide association studies (GWAS) on depression and the age proxy indicators. We employed five MR analysis methods to address potential biases and ensure robustness of our results, with the inverse variance weighted (IVW) method being the primary outcome. We also conducted outlier exclusion using Radial MR, MRPRESSO, and MR Steiger filters. Additionally, sensitivity analyses were performed to assess heterogeneity and pleiotropy.

RESULTS: Our MR analysis revealed that depression causally leads to shortened telomere length (β = – 0.014; P = 0.038), increased frailty index (β = 0.076; P = 0.000), and accelerated GrimAge (β = 0.249; P = 0.024). Furthermore, our findings showed that the frailty index (OR = 1.679; P = 0.001) was causally associated with an increased risk of depression. Additionally, we found that appendicular lean mass (OR = 0.929; P = 0.000) and left-hand grip strength (OR = 0.836; P = 0.014) were causally associated with a reduced risk of depression. Sensitivity analyses demonstrated the robustness of our findings.

CONCLUSIONS: Our study provides evidence that depression contributes to the accelerated aging process, resulting in decreased telomere length, increased frailty index, and accelerated GrimAge. Additionally, we found that the frailty index increases the risk of depression, while appendicular lean mass and left-handed grip strength reduce the risk of depression.

PMID:37999829 | DOI:10.1007/s40520-023-02596-4

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Nevin Manimala Statistics

Effect of preoperative single-dose methylprednisolone administration on early postoperative pain following retrograde intrarenal surgery

Int Urol Nephrol. 2023 Nov 24. doi: 10.1007/s11255-023-03875-9. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the effect of preoperative single-dose methylprednisolone use on postoperative early pain after retrograde intrarenal surgery (RIRS).

METHODS: Patients who had 10-20 mm solitary kidney stones and underwent RIRS procedures were included in this prospective cohort study between February 2022 and May 2023. Patients who were administered methylprednisolone at a dose of 1 mg/kg preoperatively were included in group 1 (n: 31), and the other first 90 patients who met the inclusion criteria and did not receive methylprednisolone before surgery were included in group 2 (n: 90). Demographic data, features of stone, postoperative pain at 1, 6, 12, 18, and 24 hour, the need for analgesics, changes in serum glucose levels, and the prevalence of postoperative fever were compared.

RESULTS: Age, sex, stone laterality, localization, size, Hounsfield Unit, modified Satava scores, stone-free status, duration of the RIRS procedure, and duration of the ureteral access sheath were found to be similar between groups. Visual Analog Scale (VAS) scores at postoperative 1, 6, 12, 18, and 24 h were found to be statistically significantly lower in group 1 (p = .001, p = .001, p = .001, p = .001, and p = .001, respectively). Similarly, postoperative analgesic requirements were found to be significantly lower in group 1 (p = .048) with a similar postoperative fever rate and changes in serum glucose levels between groups.

CONCLUSION: Giving a single dose of methylprednisolone at a dose of 1 mg/kg preoperatively for the RIRS procedure is safe and effective at preventing early pain and the need for analgesics after the RIRS procedure.

PMID:37999826 | DOI:10.1007/s11255-023-03875-9