Tag: nevin manimala

Cancer Biomark. 2023 Oct 18. doi: 10.3233/CBM-230181. Online ahead of print.

ABSTRACT

BACKGROUND: The initiation biomarker-driven trials have revolutionized oncology drug development by challenging the traditional phased approach and introducing basket studies. Notable successes in non-small cell lung cancer (NSCLC) with ALK, ALK/ROS1, and EGFR inhibitors have prompted the need to expand this approach to other cancer sites.

OBJECTIVES: This study explores the use of dose response modeling and time-to-event algorithms on the biomarker molecular targeted agent (MTA). By simulating subgroup identification in MTA-related time-to-event data, the study aims to develop statistical methodology supporting biomarker-driven trials in oncology.

METHODS: A total of n patients are selected assigned for different doses. A dataset is prepared to mimic the situation on Subgroup Identification of MTA for time to event data analysis. The response is measured through MTA. The MTA value is also measured through ROC. The Markov Chain Monte Carlo (MCMC) techniques are prepared to perform the proposed algorithm. The analysis is carried out with a simulation study. The subset selection is performed through the Threshold Limit Value (TLV) by the Bayesian approach.

RESULTS: The MTA is observed with range 12-16. It is expected that there is a marginal level shift of the MTA from pre to post-treatment. The Cox time-varying model can be adopted further as causal-effect relation to establishing the MTA on prolonging the survival duration. The proposed work in the statistical methodology to support the biomarker-driven trial for oncology research.

CONCLUSION: This study extends the application of biomarker-driven trials beyond NSCLC, opening possibilities for implementation in other cancer sites. By demonstrating the feasibility and efficacy of utilizing MTA as a biomarker, the research lays the foundation for refining and validating biomarker use in clinical trials. These advancements aim to enhance the precision and effectiveness of cancer treatments, ultimately benefiting patients.

PMID:37980650 | DOI:10.3233/CBM-230181

J Back Musculoskelet Rehabil. 2023 Oct 19. doi: 10.3233/BMR-230077. Online ahead of print.

ABSTRACT

BACKGROUND: There has been a dearth of research into the benefits of water-based workouts for ankylosing spondylitis (AS) patients.

OBJECTIVE: This study aimed to compare the effect of Aqua Stretch and Aqua Pilates in improving quality of life (QOL), function, and pain in AS patients.

METHODS: This study was conducted on 40 patients, who were randomly assigned to the Aqua Pilates, Aqua Stretch, and control groups. The experimental groups attended interventions for six-week. QOL, pain intensity, function, and fatigue were measured before and after treatments.

RESULTS: Except for the chest expanding, all variables in the Aqua Stretch group changed significantly after six weeks (p< 0.05). QOL (p= 0.002), 6MWT (p= 0.016), and Schober flexion (p= 0.011) showed changes, while BASDAI (p= 0.0001), VAS (p= 0.0001), fatigue (p= 0.0001), and Schober extension (p= 0.028) showed significant decreases. Except for chest expansion and Schober extension, which did not alter significantly after six-week of Aqua Pilates (p> 0.05), all other variables did. There was an increasing trend in 6MWT and Schober flexion (p= 0.021) and a decreasing trend in BASDAI (p= 0.002), VAS (p= 0.0001) and fatigue (p= 0.002). Except for QOL (p= 0.016), no statistically significant differences were found between the groups.

CONCLUSION: All variables had a significant change after six-week Aqua Stretch, except for the chest expanding. Chest expanding and Schober extension were the variables which had no significant change after six-week Aqua Pilates. With the exception of QOL, no statistically significant differences were found between the groups. Aqua Stretch had the greatest effect on the VAS, as measured by the minimum clinically relevant differences (MCID). Moreover, in Aqua Stretch alone, there was a notable impact on fatigue, QOL, and the BASDAI.

PMID:37980643 | DOI:10.3233/BMR-230077

Isr Med Assoc J. 2023 Nov;25(11):752-756.

ABSTRACT

BACKGROUND: In the past decade, numerous new imaging and laboratory tests have been implemented that significantly contribute to improved medical diagnostic capabilities. However, inappropriate utilization, which occurs on a large scale, has significant ramifications for both patient care and health systems.

OBJECTIVES: To assess the impact of a novel clinical decision support system (CDSS) applied to our electronic medical records on abdominal ultrasonography utilization pattern.

METHODS: We conducted a retrospective cohort study comparing patterns of abdominal ultrasound utilization in cases of liver enzyme elevation, with and without CDSS, between February and May in 2017 (before CDSS implementation) and during the same months in 2018 (after CDSS implementation). The following parameters were collected: number of tests ordered according to the guidelines, tests with a diagnostic value, and order forms completed with any data or a diagnostic question. The comparison was conducted using chi-square test.

RESULTS: Of 152 abdominal ultrasound tests, 72 were ordered in the pre-implementation period and 80 in the post-implementation period. The system failed to reach statistical significance regarding the rates of ordered tests according to the guidelines and/or tests with a diagnostic value. However, the use of the CDSS had a statistically significant impact regarding completing the order form with data, including a specific diagnostic question.

CONCLUSIONS: The effect of the system on the efficiency of test utilization was partial. However, our findings strongly suggested that CDSS has the potential to promote proper usage of complementary technologies.

PMID:37980621

Isr Med Assoc J. 2023 Nov;25(11):729-734.

ABSTRACT

BACKGROUND: Helicobacter pylori (H. pylori) prevalence varies according to both geographical region and ethnicity. The interplay between these two factors has been poorly studied.

OBJECTIVES: To determine the positivity rate of H. pylori infection among Jewish and Arab patients who live in a mixed urban center in Israel.

METHODS: Between November 2009 and September 2014, dyspeptic patients referred to a gastroenterology clinic in Lod, Israel, were enrolled in a prospective study. For each patient, clinical and epidemiological data were collected and a noninvasive or endoscopy-based test for H. pylori was performed.

RESULTS: A total of 429 consecutive patients (322 Jewish and 107 Arabs), mean age 45 years (range 15-91 years) were included; 130 males. Overall positivity for H. pylori was 42.4% (182/429). The positivity rate of H. pylori was 38.8% for Jews (125/322) and 53.2% for Arabs (57/107) in Lod (P < 0.01). When immigrants were excluded, the difference in H. pylori positivity did not reach statistical significance (45.0% [77/171] vs. 53.2% [57/107], P = 0.217, in Jews and Arabs, respectively).

CONCLUSIONS: H. pylori infection was more common in Arabs that Jews in the mixed city of Lod, Israel. This finding may suggest that non-environmental factors were responsible for the observed difference in H. pylori positivity.

PMID:37980617

J Biopharm Stat. 2023 Nov 19:1-11. doi: 10.1080/10543406.2023.2280628. Online ahead of print.

ABSTRACT

It is common and important to include the patient’s perspective of the impact of treatment on health-related quality of life (HRQoL) outcomes. In this commentary, we focus on applying the new addendum to ICH E9 guideline E9 (R1) relating to the estimand framework to Patient Reported Outcomes (PROs) collected in cancer clinical trials, from a statistician’s viewpoint. Currently, common practice for statistical analysis of PRO endpoints of published cancer clinical trials demonstrates ambiguity, leaving critical questions unspecified, hindering conclusions about the effect of treatment on PRO endpoints as well as comparability between clinical trials. To avoid this scenario, we advocate the systematic use of the estimand framework which requires the prospective definition of clear PRO research questions. Among the five attributes of the estimands framework, the definition of the endpoint (what is the right PRO measure and timeframe to target and why?), the intercurrent event identification and management (what happens with PRO data post-disease progression, what is the impact of death?) and the population-level summary (what is an acceptable statistical summary for PRO data?) require the most attention for PRO estimands. We identify good practice and highlight discussion points including the challenges of statistical analysis in the presence of missing and/or unobservable data and in relation to death. Through this discussion we highlight that there is no “statistical magic”, but that the estimand framework will help you find out what you really want to know when quantifying the benefit of treatments from the patients’ perspective.

PMID:37980609 | DOI:10.1080/10543406.2023.2280628

Eur Arch Otorhinolaryngol. 2023 Nov 19. doi: 10.1007/s00405-023-08270-9. Online ahead of print.

ABSTRACT

PURPOSE: This study explores the potential of the Chat-Generative Pre-Trained Transformer (Chat-GPT), a Large Language Model (LLM), in assisting healthcare professionals in the diagnosis of obstructive sleep apnea (OSA). It aims to assess the agreement between Chat-GPT’s responses and those of expert otolaryngologists, shedding light on the role of AI-generated content in medical decision-making.

METHODS: A prospective, cross-sectional study was conducted, involving 350 otolaryngologists from 25 countries who responded to a specialized OSA survey. Chat-GPT was tasked with providing answers to the same survey questions. Responses were assessed by both super-experts and statistically analyzed for agreement.

RESULTS: The study revealed that Chat-GPT and expert responses shared a common answer in over 75% of cases for individual questions. However, the overall consensus was achieved in only four questions. Super-expert assessments showed a moderate agreement level, with Chat-GPT scoring slightly lower than experts. Statistically, Chat-GPT’s responses differed significantly from experts’ opinions (p = 0.0009). Sub-analysis revealed areas of improvement for Chat-GPT, particularly in questions where super-experts rated its responses lower than expert consensus.

CONCLUSIONS: Chat-GPT demonstrates potential as a valuable resource for OSA diagnosis, especially where access to specialists is limited. The study emphasizes the importance of AI-human collaboration, with Chat-GPT serving as a complementary tool rather than a replacement for medical professionals. This research contributes to the discourse in otolaryngology and encourages further exploration of AI-driven healthcare applications. While Chat-GPT exhibits a commendable level of consensus with expert responses, ongoing refinements in AI-based healthcare tools hold significant promise for the future of medicine, addressing the underdiagnosis and undertreatment of OSA and improving patient outcomes.

PMID:37980605 | DOI:10.1007/s00405-023-08270-9

Technol Health Care. 2023 Oct 26. doi: 10.3233/THC-231003. Online ahead of print.

ABSTRACT

BACKGROUND: Bonding between metal and ceramic is one of the most important aspects of a successful prosthesis. Various methods have been recommended for preparing the metal surface to enhance the bond between metal and ceramic including the use of a metal bonding agent.

OBJECTIVE: This study aims to evaluate and compare the shear bond strength of the metal-ceramic (M-C) interface after combinations of various surface treatments including the application of a metal bonding agent.

METHOD: 40 Ni-Cr alloy specimens were made and divided into 4 groups of 10 each based on the combination of surface treatments. Sandblasting, surface grinding, and Oxidation heat treatment (OHT) were performed on specimens from Group 1 (Control). In addition, Group 2 specimens received ultrasonic cleaning, Group 3 steam cleaning, and Group 4 metal bonding agent application. Following surface treatments on all specimens, porcelain build-up was performed, and shear bond strength was tested in a Digital Universal testing machine. The statistical tests used were independent t-test and ANOVA.

RESULTS: Results revealed that Group 4 specimens had the highest mean value of shear bond strength of 39.087 MPa while Group 3 specimens showed the least mean shear bond strength of 18.154 MPa with highly statistically significant results (p< 0.001).

CONCLUSION: The surface treatments and application of bonding agent to metal prior to porcelain application resulted in increased shear bond strength of the metal-ceramic interface.

PMID:37980583 | DOI:10.3233/THC-231003

Technol Health Care. 2023 Nov 2. doi: 10.3233/THC-230558. Online ahead of print.

ABSTRACT

BACKGROUND: The use of indwelling closed thoracic drainage tubes in the wedge resection of the lungs is of great significance to postoperative recovery. However, there are potential risks.

OBJECTIVE: To explore the design feasibility and application effect of triple-buffer-system-fixed small-diameter (18 F) thoracic closed drainage tubes following lung wedge resection.

METHODS: A total of 136 patients with indwelling thoracic drainage tubes following pulmonary wedge resection were recruited, with 70 patients allocated to the control group and 66 to the experimental group. The drainage tube in the experimental group was fixed with the triple-buffer system, while that in the control group was fixed using the conventional lifting platform method. The incidence of unplanned extubation, the indwelling time of the drainage tube and the time and material costs, as well as information regarding any subcutaneous emphysema and skin tension blisters, were recorded following the operation. The pain and degree of comfort were assessed using a chi-square test and a rank sum t-test to compare the differences between the two groups.

RESULTS: There were no statistically significant differences in terms of age, gender and sweating between the two groups. Compared with the control group, the unplanned extubation rate of the experimental group was lower (χ2= 8.513; P= 0.004), the indwelling time of the drainage tube was shorter (t= 2.108; P= 0.037), the cumulative material cost was lower (t= 3.778; P< 0.001), the time cost was also lower (Z= 2.717; P= 0.008), the degree of comfort was higher (Z= 2.752; P= 0.006), and the degree of pain was lower (Z= 4.019; P< 0.001). The incidence of subcutaneous emphysema was significantly lower in the experimental group than in the control group (χ2= 8.513; P= 0.004).

CONCLUSION: The use of the triple-buffer system to fix small-diameter (18 F) thoracic closed drainage tubes can reduce the unplanned extubation rate, indwelling time of the drainage tube and the incidence of adverse reactions.

PMID:37980577 | DOI:10.3233/THC-230558

STAR Protoc. 2023 Nov 18;4(4):102733. doi: 10.1016/j.xpro.2023.102733. Online ahead of print.

ABSTRACT

Agent-based models are composed of individual agents coded for traits, such as cooperation and cheating, that interact in a virtual world based on defined rules. Here, we describe the use of an agent-based model of homologous recombination in bacteria playing a public goods game. We describe steps for software installation, setting model parameters, running and testing models, and visualization and statistical analysis. This protocol is useful in analyses of horizontal gene transfer, bacterial sociobiology, and game theory. For complete details on the use and execution of this protocol, please refer to Lee et al.¹.

PMID:37980566 | DOI:10.1016/j.xpro.2023.102733

Parasit Vectors. 2023 Nov 18;16(1):425. doi: 10.1186/s13071-023-06026-2.

ABSTRACT

BACKGROUND: We describe the spatial distribution of Echinococcus multilocularis in its main definitive host, the red fox, and the distribution of human cases of alveolar echinococcosis (AE) within a highly endemic focus in southern Germany (13.7-19.9/100,000 in 1992-2018). Human cases were unequally distributed within the endemicity focus. The purpose of the study was to test whether this is reflected in the small-scale distribution of E. multilocularis in foxes.

METHODS: Three areas with contrasting numbers of human cases were selected within the counties of Ravensburg and Alb-Donau, Baden-Württemberg, Germany. From 2018 to 2020, a total of 240 fox carcasses were obtained from traditional hunters in these areas. Carcasses were necropsied and examined for the presence of intestinal helminths. The statistical analysis was performed with SAS version 9.4, and the geo-mapping with QGIS version 3.16.0 Hannover.

RESULTS: The prevalence of E. multilocularis in foxes was 44/106 (41.5%) in area I (commune Leutkirch and environs), 30/59 (50.8%) in area II (commune Isny and environs), and 31/75 (41.3%) in area III (commune Ehingen and environs). From 1992 to 2018, a total of nine human cases of alveolar echinococcosis were recorded in area I, five cases were recorded in study area III, and no cases were recorded in area II. No statistically significant differences between the areas were observed (P > 0.05) for intestinal infections with E. multilocularis, and no apparent spatial correlation with the small-scale distribution of human cases was found. Concerning other zoonotic helminths, Toxocara spp. were equally common, with prevalence of 38.7%, 47.4% and 48.0%, respectively, while the frequency of Alaria alata varied among the study areas (0.0-9.4%), probably reflecting the specific habitat requirements for the establishment of its complex life cycle.

CONCLUSIONS: Echinococcus multilocularis is highly prevalent in foxes in all the studied areas. The varying number of human AE cases within these areas should therefore be caused by factors other than the intensity of parasite transmission in foxes.

PMID:37980538 | DOI:10.1186/s13071-023-06026-2