Category: Statistics

Pharmeur Bio Sci Notes. 2023;2023:81-111.

ABSTRACT

An international collaborative study was run within the framework of the Biological Standardisation Programme (BSP) of the Council of Europe and the Commission of the European Union to establish replacement batches for European Pharmacopoeia (Ph. Eur.) Heparin Low-Molecular-Mass (LMM) for calibration Chemical Reference Substance batch 3 (CRS3) used for the characterisation of LMM heparins by high performance size-exclusion chromatography. Two candidate batches (A, cCRS4 and B, cCRS5) were filled using the same material as the existing official calibrants, adopted with either an assigned number-average molecular mass (Mna) or a broad standard table (BST). Fifteen laboratories evaluated the suitability of these candidate batches for use as calibrants with the pharmacopoeial dual refractive index/ultraviolet (RI/UV) detector calibration method, as well as with a modified mobile phase and the BST calibration method. Seven preparations of LMM heparin were tested. The results confirmed that the proposed batches are suitable for use with the same characteristic Mna as CRS3 and with the BST established for the World Health Organization (WHO) 2^nd International Standard (IS). The BST calibration method gave comparable results to the RI/UV method, while showing better reproducibility, being easier to perform and requiring no calibrant with UV absorbance. The modified mobile phase had no impact on the calculated values while improving separation between the calibrant and salt peaks. The two candidate batches were adopted as Ph. Eur. Heparin LMM for calibration CRS batches 4 and 5, respectively, with the assigned Mna value of 3800 and a BST. In anticipation of the depletion of the calibrant required for use with the RI/UV method, and taking into account the unlikely procurement of a new lot of suitable starting material, it was recommended to include the BST method in Ph. Eur. monograph 0828, Heparins, low-molecular-mass. In order to improve peak separation, it was also recommended to include the use of ammonium acetate solution as mobile phase in the monograph, both for the Ph. Eur. RI/UV and the proposed BST calibration methods. Further to this study, Ph. Eur. monograph 0828 was revised to replace the RI/UV method by the BST method. This contributed to the harmonisation of methods across regions, thereby facilitating a concerted global action for the development and establishment of the next batches of calibrants for the quality control of LMM heparins.

PMID:38037758

Scand J Pain. 2023 Dec 1. doi: 10.1515/sjpain-2023-0043. Online ahead of print.

ABSTRACT

OBJECTIVES: This study explored changes in pain-related parameters, occupational function, occupational balance, lifestyle factors, and self-perceived health status in adults with chronic high-impact pain participating in an occupational therapy lifestyle intervention.

METHODS: This one-group longitudinal feasibility study was performed in three continuous feasibility rounds. The occupational therapists-led intervention targeted meaningful occupations, regular physical activity, and a healthy diet. The intervention contained individual and group sessions and was added to the standard multidisciplinary chronic pain treatment. Outpatients (n=40, 85 % females, 46.6 ± 10.9 years old) participated in the study between April 2019 and December 2021. The analysis includes data for 31 participants. Analysis of pre-post changes assessed after each feasibility round were performed for the outcomes: pain intensity, pain sensitivity and pain modulation (pressure pain threshold and tolerance, temporal summation of pain and conditioned pain modulation), pain self-efficacy, pain catastrophizing, motor and process skills, occupational balance, daily wake-time movement, daily walking steps, body mass index, waist circumference, blood pressure, and self-perceived health status.

RESULTS: Improvements in motor skills (assessment of motor and process skills score=0.20 (1.37; 1.57), 95 % CI 0.01; 0.38) and temporal summation of pain (-1.19 (2.86; -1.67), 95 % CI -2.16; -0.22), but a decrease in pain tolerance (-7.110 (54.42; 47.32), 95 % CI -13.99; -0.22) were observed. Correlation analysis suggested moderate-to-very strong statistically significant relationships in several outcomes related to pain, health, pain coping, occupational balance, occupational functioning, body anthropometrics, and pain sensitivity.

CONCLUSIONS: This study suggested that the lifestyle intervention would benefit motor skills while effects on other outcomes were unclear in adults with chronic pain. To confirm the findings, a randomized trial evaluating effectiveness is needed. Ethical committee number: SJ-307 Reg. Clinicaltrials.gov: NCT03903900.

PMID:38037749 | DOI:10.1515/sjpain-2023-0043

Mol Oncol. 2023 Dec 1. doi: 10.1002/1878-0261.13557. Online ahead of print.

ABSTRACT

Several studies have demonstrated the prognostic value of circulating tumor DNA (ctDNA); however, the correlation of mean tumor molecules (MTM)/ml of plasma and mean variant allele frequency (mVAF; %) with clinical parameters is yet to be understood. In this study, we analyzed ctDNA data in a pan-cancer cohort of 23,543 patients who had ctDNA testing performed using a personalized, tumor-informed assay (Signatera^TM , mPCR-NGS assay). For ctDNA-positive patients, correlation between MTM/ml and mVAF was examined. Two sub-analyses were performed: 1) to establish the association of ctDNA with tumor volume, and 2) to assess the correlation between ctDNA dynamics and patient outcomes. On a global cohort, a positive correlation between MTM/ml and mVAF was observed. Among 18,426 patients with longitudinal ctDNA measurements, 13.3% had discordant trajectories between MTM/ml and mVAF at subsequent timepoints. In metastatic patients receiving immunotherapy (N=51), changes in ctDNA levels expressed both in MTM/ml and mVAF showed a statistically significant association with progression-free survival; however, the correlation with MTM/ml was numerically stronger.

PMID:38037739 | DOI:10.1002/1878-0261.13557

Public Health Nutr. 2023 Dec 1:1-22. doi: 10.1017/S1368980023002665. Online ahead of print.

ABSTRACT

OBJECTIVES: To estimate the cost and affordability of healthy diets recommended by the 2016-2020 Vietnamese food-based dietary guidelines (FBDGs).

DESIGN: Cross-sectional analysis. The Cost of a Healthy Diet (CoHD) indicator was used to estimate the lowest cost of healthy diets and compare the cost differences by food group, region, and seasonality. The affordability of healthy diets was measured by further comparing the CoHD to food expenditures and incomes.

SETTING: Food prices of 176 food items from January 2016 to December 2020 were derived using data from monthly Consumer Price Index databases nationally and regionally.

PARTICIPANTS: Food expenditures and incomes of participants from three latest Vietnamese Household Living Standard Surveys was used.

RESULTS: The average CoHD between 2016 and 2020 in Vietnam was 3.08 international dollars using 2017 Purchasing Power Parity (24,070 Vietnamese Dongs). The nutrient-rich food groups, including protein-rich foods, vegetables, fruits, and dairy, comprised approximately 80% of the total CoHD in all regions, with dairy accounting for the largest proportion. Between 2016 and 2020, the cheapest form of a healthy diet was affordable for all high-income and upper-middle-income households but unaffordable for approximately 70% of low-income households, where adherence to the Vietnamese FBDGs can cost up to 70% of their income.

CONCLUSIONS: Interventions in local food systems must be implemented to reduce the cost of nutrient-rich foods to support the attainment of healthier diets in the Vietnamese population, especially for low-income households.

PMID:38037710 | DOI:10.1017/S1368980023002665

Eur J Heart Fail. 2023 Dec 1. doi: 10.1002/ejhf.3101. Online ahead of print.

ABSTRACT

BACKGROUND: Extracellular matrix remodeling is one of the key pathways involved in heart failure (HF) progression. SGLT2 inhibitors may have a role in attenuating myocardial fibrosis. The impact of SGLT2 inhibitors on blood markers of collagen turnover in humans is not fully elucidated.

AIMS: To investigate the effect of empagliflozin on serum markers of collagen turnover in patients enrolled in the EMPEROR-Preserved and EMPEROR-Reduced trials.

METHODS: 1084 patients (545 in empagliflozin and 539 in placebo) were included in the analysis. PICP, PRO-C3, PINP, PRO-C6, C1M, and C3M were measured in serum at baseline, 12 and 52 weeks. A mixed model repeated measurements model (MMRM) was used to evaluate the effect of empagliflozin vs. placebo on the analysed biomarkers.

RESULTS: Higher baseline PICP, PRO-C6 and PINP levels were associated with older age, a more severe HF presentation, higher levels of natriuretic peptides and high-sensitivity troponin T, and the presence of comorbid conditions such as chronic kidney disease and atrial fibrillation. Higher PICP levels were associated with the occurrence of the study primary endpoint (a composite of HF hospitalization or cardiovascular death), and PRO-C6 and PINP were associated with the occurrence of sustained worsening of kidney function. On the other hand, PRO-C3, C1M, and C3M were not associated with worse HF severity or study outcomes. Compared to placebo, empagliflozin reduced PICP at week 12 by 5% and at week 52 by 8% (week 12 gMean ratio = 0.95, 95%CI [0.91, 0.99], p = 0.012; week 52 gMean ratio = 0.92, 95%CI [0.88, 0.97], p = 0.003). Additionally, empagliflozin reduced PRO-C3 at week 52 by 7% (week 12 gMean ratio = 0.98, 95%CI [0.95, 1.02], p = 0.42; week 52 gMean ratio = 0.93, 95%CI [0.89, 0.98], p = 0.003), without impact on other collagen markers.

CONCLUSION: Our observations are consistent with experimental observations that empagliflozin down-regulates profibrotic signalling. The importance of such an effect for the clinical benefits of SGLT2 inhibitors in HF remains to be elucidated. This article is protected by copyright. All rights reserved.

PMID:38037709 | DOI:10.1002/ejhf.3101

Minerva Dent Oral Sci. 2023 Nov 30. doi: 10.23736/S2724-6329.23.04791-5. Online ahead of print.

ABSTRACT

BACKGROUND: The treatments with clear aligners (CA) showed an exponential higher percentage in the last years being almost invisible with major patient acceptability and a resulting improvement in quality of life. CA are composed of thermoplastic polyurethane not inert but subjected to changes due to heating and humidity, chewing forces, and prolonged exposure to enzymes in saliva in the oral cavity and external factors. Cigarette smoke (CS) and the aerosol produced by tobacco products with reduced health risks may be considered among the external factors affecting CA. The purpose of this study was the assessment of optical properties (absorbance and transmittance) and roughness of CA after in vitro aging due to exposition to CS and THS2.2, compared to controls. The secondary objective will be the investigation of CS and THS2.2 effects on resin composite inside aligners used for attachments during treatment with CA.

METHODS: A total number of 60 CA units will be used and equally divided in three different groups (20 in each): CS group exposed to reference cigarettes smoking, THS2.2 group exposed to aerosol from 20 heat-not-burn sticks, and control group, CG to pure air only. The aligners will present ten introflection for the attachments on the anterior part. In accordance with ISO standard 3402, 3R4F cigarettes and THS2.2 tobacco sticks must undergo conditioning for a minimum of 48 hours and a maximum of 21 days at a temperature of 22±1 °C and a relative humidity of 60±3%.

RESULTS: Using spectrophotometry, the optical characteristics (absorbance and transmittance) of each aligner will be evaluated after aging (Jasco UV-vis V630PC, Tokyo, Japan). Each aligner will be cut with a rotating saw from canine to canine prior to the measurements in order to lop off the lingual region and displaying the labial barrier. The absorbance and transmittance measurements will be collected and statistically analyzed with a significance of P<0.05.

CONCLUSIONS: Surface roughness of the aligners and attachments inside them will be assessed by 3D scanning microscopy (Infinite Focus G4h). Color of resin composite will be assessed using the (CIE Lab) Commission Internationale de l’Eclairage L*a*b* color space by means of Olympus CrystalEyef dental spectrophotometer. Clinicians should advise patients to refrain from smoking and drinking coffee or tea while wearing aligners for two reasons: first, the color change is unacceptably noticeable when wearing aligners, and second, the material’s chemical composition may be slightly altered, which could affect the intended dental movements.

PMID:38037696 | DOI:10.23736/S2724-6329.23.04791-5

BMC Med Educ. 2023 Nov 30;23(1):909. doi: 10.1186/s12909-023-04887-w.

ABSTRACT

BACKGROUND: Across higher education, student retention, progression, and graduation are considered essential elements of students’ academic success. However, there is scarce literature analyzing these attributes across health professions education. The current study aims to explore rates of student retention, progression, and graduation across five colleges of the Health Cluster at Qatar University, and identify predictive factors.

METHODS: Secondary longitudinal data for students enrolled at the Health Cluster between 2015 and 2021 were subject to descriptive statistics to obtain retention, progression and graduation rates. The importance of student demographic and academic variables in predicting retention, progression, or graduation was determined by a predictive model using XGBoost, after preparation and feature engineering. A predictive model was constructed, in which weak decision tree models were combined to capture the relationships between the initial predictors and student outcomes. A feature importance score for each predictor was estimated; features that had higher scores were indicative of higher influence on student retention, progression, or graduation.

RESULTS: A total of 88% of the studied cohorts were female Qatari students. The rates of retention and progression across the studied period showed variable distribution, and the majority of students graduated from health colleges within a timeframe of 4-7 years. The first academic year performance, followed by high school GPA, were factors that respectively ranked first and second in importance in predicting retention, progression, and graduation of health majors students. The health college ranked third in importance affecting retention and graduation and fifth regarding progression. The remaining factors including nationality, gender, and whether students were enrolled in a common first year experience for all colleges, had lower predictive importance.

CONCLUSIONS: Student retention, progression, and graduation at Qatar University Health Cluster is complex and multifactorial. First year performance and secondary education before college are important in predicting progress in health majors after the first year of university study. Efforts to increase retention, progression, and graduation rates should include academic advising, student support, engagement and communication. Machine learning-based predictive algorithms remain a useful tool that can be precisely leveraged to identify key variables affecting health professions students’ performance.

PMID:38036997 | DOI:10.1186/s12909-023-04887-w

BMC Gastroenterol. 2023 Nov 30;23(1):423. doi: 10.1186/s12876-023-03057-y.

ABSTRACT

BACKGROUND: The present study aims to explore the clinical application of enhanced recovery after surgery (ERAS) in pediatric patients with congenital upper gastrointestinal obstruction (CUGIO).

METHODS: A total of 82 pediatric patients with CUGIO admitted to the neonatal intensive care unit in Kunming Children’s Hospital between June 2017 and June 2021 were enrolled in the present study and divided into two groups: the ERAS group (n = 46) and the control group (n = 36). The ERAS management mode was adopted in the ERAS group, and the conventional perioperative management mode was adopted in the control group.

RESULTS: In the ERAS group and the control group, the time to the first postoperative bowel movement was 49.2 ± 16.6 h and 58.4 ± 18.8 h, respectively, and the time to the first postoperative feeding was 79 ± 7.1 h and 125.2 ± 8.3 h, respectively. The differences in the above two indicators between the two groups were statistically significant (P < 0.05). In the ERAS group, the days of parenteral nutrition and the length of hospital stay were 14.5 ± 2.3 d and 18.8 ± 6.4 d, respectively. In the control group, 17.6 ± 2.2 d and 23.1 ± 8.1 d, respectively. The differences in these two indicators between the two groups were statistically significant (P < 0.05).

CONCLUSION: The ERAS management model had a positive effect on early postoperative recovery in pediatric patients with CUGIO.

PMID:38036993 | DOI:10.1186/s12876-023-03057-y

BMC Oral Health. 2023 Nov 30;23(1):948. doi: 10.1186/s12903-023-03693-6.

ABSTRACT

BACKGROUND: Attachment material is one of the contributing factors to the degree of wear of the attachment components in mandibular implant-retained overdentures. The purpose of this in vitro study was to compare the wear behavior of 2 different attachment systems of dissimilar materials in mandibular implant-retained overdentures by qualitative and quantitative methods.

METHODS: Two attachment systems of different materials were utilized (n = 16); Titach (Dental Evolutions Inc, Beverly Hills, CA, USA) with a titanium-to-titanium interface and Locator R-Tx (Zest Anchors Inc, Escondido, CA, USA) with a titanium-to-nylon interface. One thousand cycles of overdenture insertion and removal simulating 1-year clinical use were performed. All matrices were removed from the overdentures and all patrices were unscrewed from the implants for wear assessment quantitively using a stereomicroscope and qualitatively using a scanning electron microscope. Data were analyzed by using an independent sample t test.

RESULTS: After cyclic loading, stereomicroscopic findings showed that the Titach group had statistically significant higher wear value than the Locator R-Tx group (p < 0.001). Moreover, scanning electron microscopy images showed noticeable abrasion in Titach patrix at the area of highest convexity. However, the Locator R-Tx matrix displayed an apparent tear of rubber inserts.

CONCLUSIONS: Titach attachment with the titanium-to-titanium interface revealed more wear than Locator R-Tx attachment with the titanium-to-nylon interface. Thus, the type of attachment material influences the degree of wear of the attachment components.

PMID:38036982 | DOI:10.1186/s12903-023-03693-6

BMC Med Res Methodol. 2023 Nov 30;23(1):283. doi: 10.1186/s12874-023-02101-5.

ABSTRACT

BACKGROUND AND OBJECTIVE: Clinical practice guidelines (CPGs) are evaluated for quality with the Appraisal of Guidelines for Research and Evaluation (AGREE) tool, and this is increasingly done for different countries and regional groupings. This scoping review aimed to describe, map, and compare these geographical synthesis studies, that assessed CPG quality using the AGREE tool. This allowed a global interpretation of the current landscape of these country-wide or regional synthesis studies, and a closer look at its methodology and results.

STUDY DESIGN AND METHODS: A scoping review was conducted searching databases Medline, Embase, Epistemonikos, and grey literature on 5 October 2021 for synthesis studies using the later versions of AGREE (AGREE II, AGREE-REX and AGREE GRS) to evaluate country-wide or regional CPG quality. Country-wide or regional synthesis studies were the units of analysis, and simple descriptive statistics was used to conduct the analysis. AGREE scores were analysed across subgroups into one of the seven Sustainable Development Goal regions, to allow for meaningful interpretation.

RESULTS: Fifty-seven studies fulfilled our eligibility criteria, which had included a total of 2918 CPGs. Regions of the Global North, and Eastern and South-Eastern Asia were most represented. Studies were consistent in reporting and presenting their AGREE domain and overall results, but only 18% (n = 10) reported development methods, and 19% (n = 11) reported use of Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Overall scores for domains Rigor of development and Editorial independence were low, notably in middle-income countries. Editorial Independence scores, especially, were low across all regions with a maximum domain score of 46%. There were no studies from low-income countries.

CONCLUSION: There is an increasing tendency to appraise country-wide and regionally grouped CPGs, using quality appraisal tools. The AGREE tool, evaluated in this scoping review, was used well and consistently across studies. Findings of low report rates of development of CPGs and of use of GRADE is concerning, as is low domain scores globally for Editorial Independence. Transparent reporting of funding and competing interests, as well as highlighting evidence-to-decision processes, should assist in further improving CPG quality as clinicians are in dire need of high-quality guidelines.

PMID:38036974 | DOI:10.1186/s12874-023-02101-5