Tag: nevin manimala

J Biopharm Stat. 2022 Nov 7:1-17. doi: 10.1080/10543406.2022.2141769. Online ahead of print.

ABSTRACT

Overall survival, progression-free survival, objective response/complete response, and duration of (complete) response are frequently used as the primary and secondary efficacy endpoints for designs and analyses of oncology clinical trials. However, these endpoints are typically analyzed separately. In this article, we introduce an evidence synthesis approach to prioritize the benefit outcomes by applying the generalized pairwise comparisons (GPC) method, and use win statistics (win ratio, win odds and net benefit) to quantify treatment benefit. Under the framework of GPC, the main advantage of this evidence synthesis approach is the ability to combine relevant outcomes of various types into a single summary statistic without relying on any parametric assumptions. It is particularly relevant since health authorities and the pharmaceutical industry are increasingly incorporating structured quantitative methodologies in their benefit-risk assessment. We apply this evidence synthesis approach to an oncology phase 3 study in first-line renal cell carcinoma to assess the overall effect of an investigational treatment by ranking the most clinically relevant endpoints in cancer drug development. This application and a simulation study demonstrate that the proposed approach can synthesize the evidence of treatment effect from multiple prioritized benefit outcomes, and has substantial advantage over conventional methods that analyze each individual endpoint separately. We also introduce a newly developed R package WINS for statistical inference based on win statistics.

PMID:36343174 | DOI:10.1080/10543406.2022.2141769

Cornea. 2022 Dec 1;41(12):1525-1529. doi: 10.1097/ICO.0000000000003033. Epub 2022 Mar 30.

ABSTRACT

PURPOSE: To assess the changes in the posterior corneal curvature after pre-Descemet’s endothelial keratoplasty (PDEK) and correlate with the visual outcomes.

METHODS: Eyes with pseudophakic bullous keratopathy, aphakic bullous keratopathy, and Fuchs dystrophy undergoing PDEK were included. The main outcome measures were the topography (OrbscanIIz, Bausch and Lomb) indices-total corneal power (TCP) in diopters (D), radius of the posterior curvature (mm), and best-fit sphere of the posterior corneal surface (BFS in D) at preoperative and postoperative 1 month, 3 months, and 6 months.

RESULTS: Overall, 43 eyes of 43 patients with a mean age of 68 ± 9.6 years were studied. The mean preoperative TCP 43.1 D ± 2.3 reduced to 42.4 D ± 2.6 at 3 months (P < 0.010). There was a statistically significant decrease in the mean posterior corneal curvature at 1 month and 3 months postoperatively (P = 0.002). There was no significant change in the TCP and posterior corneal curvature at 6 months (P > 0.05). The mean BFS showed an increase at 1 month (53.45 ± 5.2 D) and 3 months (52.95 ± 5.1 D) and decrease at 6 months (51.90 ± 5.3 D). The overall change in BFS (P > 0.05) was not significant. There was significant improvement in visual acuity (P < 0.05). The best-corrected visual acuity was ≥20/40 in 79.07% and ≥20/60 in 100% at 6 months. There was no statistically significant correlation between the change in the best-corrected visual acuity and TCP, posterior corneal curvature, or BFS.

CONCLUSIONS: Although there was immediate postoperative change in the posterior curvature, no significant change was induced by PDEK.

PMID:36343167 | DOI:10.1097/ICO.0000000000003033

Cornea. 2022 Dec 1;41(12):1519-1524. doi: 10.1097/ICO.0000000000003024. Epub 2022 Apr 8.

ABSTRACT

PURPOSE: The purpose of this study was to report the 2-year outcomes of a double-blinded randomized controlled trial comparing Descemet membrane endothelial keratoplasty (DMEK) and microthin Descemet stripping automated endothelial keratoplasty (MT-DSAEK).

METHODS: Fifty-six eyes of 56 patients were randomized to DMEK or microthin DSAEK (MT-DSAEK). The main outcome measure was best spectacle-corrected visual acuity (BSCVA) at 24 months. Other secondary outcomes included complications, endothelial cell density, and vision-related quality-of-life (vQoL) scores.

RESULTS: There was no statistically significant difference in BSCVA between the DMEK and MT-DSAEK groups at the 2-year time point (mean ± SD; 0.04 ± 0.14 vs. 0.12± 0.19, P = 0.061) in contrast to the 1-year results (mean ± SD; 0.04 ± 0.13 vs. 0.11 ± 0.09, P = 0.002) previously reported. Endothelial cell density did not show a statistically significant difference at 24 months between the DMEK and MT-DSAEK groups (1522 ± 293 cell/mm2 vs. 1432 ± 327 cells/mm2, P = 0.27). There were 2 additional graft rejection episodes in the MT-DSAEK group between the 1- and 2-year follow-up periods, but this did not result in graft failure. The mean vQoL scores between DMEK and MT-DSAEK indicated similar patient satisfaction between the groups (97.1 ± 4.0 vs. 92.6 ± 10.2, P = 0.13).

CONCLUSIONS: In summary, the trial showed no significant difference in BSCVA at 24 months between the DMEK and MT-DSAEK groups. Both techniques continued to demonstrate comparable outcomes for complication rates, endothelial cell loss, and patient-reported vQoL scores.

TRIAL REGISTRATION: ISRCTN10578843.

PMID:36343166 | DOI:10.1097/ICO.0000000000003024

Ann Hum Biol. 2022 Nov 7:1-26. doi: 10.1080/03014460.2022.2144447. Online ahead of print.

ABSTRACT

Background Owing to its high copy number and its small size, mtDNA analysis is the most reliable choice when biological materials from crime scenes are degraded or have mixed STR profiles. Aim: To examine the occurrence of heteroplasmy along with its frequency and pattern in both HV1 and HV2 regions of the mtDNA among unrelated individuals from India. Subjects and methods: Mitochondrial DNA control region [hypervariable region one (HV1) and hypervariable region two (HV2)] were analysed in blood and buccal tissues of 104 unrelated individuals from the Indian state of Gujarat. Results: A high frequency of point heteroplasmy (PH) and length heteroplasmy (LH) was revealed. PH was detected in 7.69% of the population, with a higher frequency observed in blood than in buccal samples. However, there were no statistically significant differences in PH between the two tissues (Chi-square = 0.552, p ≥ 0.05). A total of six PH positions were detected: three at HV1, and another three at HV2. The studied population showed 46.15% LH in the HV1 and HV2 regions of both tissues. The LH positions observed in the Gujarat population were the same as those previously reported at HV1 np16184-16193 and HV2 np303-315. Conclusions: Our findings suggest that differences in the pattern of heteroplasmy found in different tissues can complicate the forensic analysis, on the other hand, the probability of a match between the questioned and reference samples increases when the heteroplasmy is identical in both tissues. Variability of PH among persons and even within tissues recommends analysing multiple tissue samples before drawing a conclusion in forensic mtDNA analyses.

PMID:36343161 | DOI:10.1080/03014460.2022.2144447

Inorg Chem. 2022 Nov 7. doi: 10.1021/acs.inorgchem.2c02065. Online ahead of print.

ABSTRACT

An approach to estimate the uncertainty of the calculated through the monomer cycle cluster-continuum model Gibbs free energy of transfer has been developed and suggested to be used as a quantitative measure of the reliability of the predictions. A set of experimental Na⁺ free energies of transfer from water to 18 solvents (ΔG_tr(Na⁺, W → S)) has been assessed. For all solvents, we find Na⁺(S)_n clusters to be thermodynamically unstable if n > 5. For 1,2-dichloroethane (1,2-DCIE), we have resolved considerable (ca. 10 kcal mol^-1) discrepancies between available experimental ΔG_tr(Na⁺, W → S). For 1,1-DCIE, we reject the only available experimental value and recommend our own estimate instead. We strongly propose experimental revisiting of ΔG_tr(Na⁺, W → S) for ethylene glycol and hexamethylphosphoramide. The statistical analysis performed on a set of predicted and recommended experimental ΔG_tr(Na⁺, W → S) values, in this work, results in the mean unsigned and signed deviations of 3.4 and -1.3 kcal mol^-1, respectively. The squared Pearson correlation coefficient of 0.91 encourages the extension of the utilized theoretical approach to other available experimental data on ion solvation.

PMID:36343158 | DOI:10.1021/acs.inorgchem.2c02065

Medicine (Baltimore). 2022 Nov 4;101(44):e31436. doi: 10.1097/MD.0000000000031436.

ABSTRACT

BACKGROUND: Multiple studies have revealed that Traditional Chinese Medicine (TCM) prescriptions can provide protective effect on the cardiovascular system, increase the heart rate and relieve the symptoms of patients with bradyarrhythmia. In China, the TCM treatment of bradyarrhythmia is very common, which is also an effective complementary therapy. In order to further understand the application of Chinese medicines in bradyarrhythmia, we analyzed the medication rules of TCM prescriptions for bradyarrhythmia by data mining methods based on previous clinical studies.

METHODS: We searched studies reporting the clinical effect of TCM on bradyarrhythmia in the PubMed and Chinese databases China National Knowledge Infrastructure database, and estimated publication bias by risk of bias tools ROB 2. Descriptive analysis, hierarchical clustering analysis and association rule analysis based on Apriori algorithm were carried out by Microsoft Excel, SPSS Modeler, SPSS Statistics and Rstidio, respectively. Association rules, co-occurrence and clustering among Chinese medicines were found.

RESULTS: A total of 48 studies were included in our study. Among the total 99 kinds of Chinese medicines, 22 high-frequency herbs were included. Four new prescriptions were obtained by hierarchical cluster analysis. 81 association rules were found based on association rule analysis, and a core prescription was intuitively based on the grouping matrix of the top 15 association rules (based on confidence level), of which Guizhi, Zhigancao, Wuweizi, Chuanxiong, Danshen, Danggui, Huangqi, Maidong, Dangshen, Rougui were the most strongly correlated herbs and in the core position.

CONCLUSION: In this study, data mining strategy was applied to explore the TCM prescription for the treatment of bradyarrhythmia, and high-frequency herbs and core prescription were found. The core prescription was in line with the treatment ideas of TCM for bradyarrhythmia, which could intervene the disease from different aspects and adjust the patient’s Qi, blood, Yin and Yang, so as to achieve the purpose of treatment.

PMID:36343087 | DOI:10.1097/MD.0000000000031436

Medicine (Baltimore). 2022 Nov 4;101(44):e31708. doi: 10.1097/MD.0000000000031708.

ABSTRACT

This study aimed to evaluate the diagnostic performance of dynamic susceptibility contrast (DSC) perfusion magnetic resonance imaging and apparent diffusion coefficient (ADC) for differentiating common posterior fossa tumors, pilocytic astrocytoma (PA), medulloblastoma (MB), and hemangioblastoma (HB). Between January 2016 and April 2022, we enrolled 23 (median age, 7 years [range, 2-26]; 12 female), 13 (10 years [1-24]; 3 female), and 12 (43 years [23-73]; 7 female) patients with PA, MB, and HB, respectively. Normalized relative cerebral blood volume and flow (nrCBV and nrCBF) and normalized mean ADC (nADCmean) were calculated from volume-of-interest and statistically compared. nADCmean was significantly higher in PA than in MB (PA: median, 2.2 [range, 1.59-2.65] vs MB: 0.93 [0.70-1.37], P < .001). nrCBF was significantly higher in HB than in PA and MB (PA: 1.10 [0.54-2.26] vs MB: 1.62 [0.93-3.16] vs HB: 7.83 [2.75-20.1], all P < .001). nrCBV was significantly different between all 3 tumor types (PA: 0.89 [0.34-2.28] vs MB: 1.69 [0.93-4.23] vs HB: 8.48 [4.59-16.3], P = .008 for PA vs MB; P < .001 for PA vs HB and MB vs HB). All tumors were successfully differentiated using an algorithmic approach with a threshold value of 4.58 for nrCBV and subsequent threshold value of 1.38 for nADCmean. DSC parameters and nADCmean were significantly different between PA, MB, and HB. An algorithmic approach combining nrCBV and nADCmean may be useful for differentiating these tumor types.

PMID:36343086 | DOI:10.1097/MD.0000000000031708

Medicine (Baltimore). 2022 Nov 4;101(44):e31441. doi: 10.1097/MD.0000000000031441.

ABSTRACT

BACKGROUND: A common concern in the literature is the comparison of the similarities and differences between research journals, as well as the types of research they publish. At present, there are no clear methodologies that can be applied to a given article of interest. When authors use an effective and efficient method to locate journals in similar fields, they benefit greatly. By using the forest plot and major medical subject headings (MeSH terms) of Spine (Phila Pa 1976) compared to Spine J, this study: displays relatively similar journals to the target journal online and identifies the effect of the similarity odds ratio of Spine (Phila Pa 1976) compared to Spine J.

METHODS: From the PubMed library, we downloaded 1000 of the most recent top 20 most similar articles related to Spine (Phila Pa 1976) and then plotted the clusters of related journals using social network analysis (SNA). The forest plot was used to compare the differences in MeSH terms for 2 journals (Spine (Phila Pa 1976) and Spine J) based on odds ratios. The heterogeneity of the data was evaluated using the Q statistic and the I-square (I2) index.

RESULTS: This study shows that: the journals related to Spine (Phila Pa 1976) can easily be presented on a dashboard via Google Maps; 8 journal clusters were identified using SNA; the 3 most frequently searched MeSH terms are surgery, diagnostic imaging, and methods; and the odds ratios of MeSH terms only show significant differences with the keyword “surgery” between Spine (Phila Pa 1976) and Spine J with homogeneity at I2 = 17.7% (P = .27).

CONCLUSIONS: The SNA and forest plot provide a detailed overview of the inter-journal relationships and the target journal using MeSH terms. Based on the findings of this research, readers are provided with knowledge and concept diagrams that can be used in future submissions to related journals.

PMID:36343077 | DOI:10.1097/MD.0000000000031441

Medicine (Baltimore). 2022 Nov 4;101(44):e31624. doi: 10.1097/MD.0000000000031624.

ABSTRACT

BACKGROUND: Safety and efficacy were assessed of different S(+)-ketamine doses combined with propofol administered as anesthesia to common pediatric congenital heart disease (CHD) patients undergoing cardiac interventional surgery to provide reference data as guidance for use in clinical settings.

METHODS: Sixty CHD children admitted to Beijing Anzhen Hospital, Capital Medical University from December 2020 to December 2021 who underwent elective cardiac intervention were assigned to 3 groups (H, L, M, 20 patients/group) using a random number table-based method. Patients received 1% propofol (2 mg/kg) and intravenous injections of S(+)-ketamine (Group L, 0.4 mg/kg; Group M, 0.5 mg/kg; Group H, 0.6 mg/kg) followed by intravenous pumping of 1% propofol (4-6 mg/kg/h). Heart rate (HR), mean arterial pressure, and pulse oxygen saturation were recorded preoperatively (T0), at the time of anesthesia maintenance (T1), at the time of arteriovenous puncture (T2), and when they awakened (T3). Additionally, propofol dose and incidence rates of intraoperative body movement, postoperative agitation, and postoperative nausea/vomiting were recorded.

RESULTS: For the 3 groups, Group H awakening time was significantly longer than that of Group L (P = .039). Notably, intergroup intraoperative propofol times differed significantly (P = .009). Meanwhile, T0 to T3 intragroup HR values differences were significant (P = .017; P = .001; P = .005, respectively). Group L HR was significantly elevated at T2 relative to T0 (P = .003), Group M HR was significantly elevated at T1 and T2 relative to T0 (P = .019; P = .003, respectively), and Group H HR values were significantly elevated at T1 and T2 relative to T0 (P = .012; P = .005, respectively). At all 4 time points no statistically significant intergroup differences in mean arterial pressure values were observed (P = .587). T1 to T3 pulse oxygen saturation values for all 3 groups were significantly greater than corresponding T0 values. Although intergroup intraoperative body movement incidence differed significantly (P = .044), intergroup differences in awakening time agitation and postoperative nausea/vomiting incidence rates were insignificant (P = .732, P = .887, respectively).

CONCLUSION: Use of 0.6 mg/kg S(+)-ketamine with propofol was most effective as anesthesia for common pediatric CHD patients undergoing cardiac interventional surgery.

PMID:36343069 | DOI:10.1097/MD.0000000000031624

Medicine (Baltimore). 2022 Nov 4;101(44):e31606. doi: 10.1097/MD.0000000000031606.

ABSTRACT

The importance of pain education is widely accepted and recognized. This is a key part of educating the undergraduate and postgraduate healthcare workforce is an essential strategy for promoting effective pain practice. This study aims to evaluate the pain management module training courses for newly graduated doctors to address the knowledge gap between specialist care and primary care physicians. This was an observational study of an evaluation of a pain education project focused on neuropathic pain management core competency was provided. Multimodal teaching approaches such as didactic teaching and vignettes of cases discussion, video teaching, and learning module. A pretest survey was carried out to assess the baseline knowledge of the participants. Completion of the post-test and participant experience questionnaire were collected. Comparison of the pre-and post-test scores for all participants was undertaken using the Wilcoxon signed-ranked test with effect size calculated. The participant’s experience questionnaire scores were analyzed descriptively to produce mean and standard deviations from each question. A total of 274 participants completed all of the course sections from the average of 350 eligible participants. Of 274 participants, more than half were female (64.96%), with more than half participants being General Practitioner (54.38%) followed by a neurologist (35.04%). For all sessions, a Wilcoxon signed-rank test outlined that differences between all pre-and post-test scores were significant (P < .001). There was a marked improvement in the post-test as evidenced by statistically significant increases in mean scores differences. We developed an educational training courses for physicians to address the limitation in existing medical undergraduate training of neuropathic pain management. The training led to improvement in participant’s knowledge and skills with positive outcomes.

PMID:36343056 | DOI:10.1097/MD.0000000000031606