Categories
Nevin Manimala Statistics

Adequacy of the examination-based licensing system and a training-based licensing system for midwifery license according to changes in childbirth medical infrastructure in Korea: a survey-based descriptive study

J Educ Eval Health Prof. 2023;20:15. doi: 10.3352/jeehp.2023.20.15. Epub 2023 May 22.

ABSTRACT

PURPOSE: The number of Korean midwifery licensing examination applicants has steadily decreased due to the low birth rate and lack of training institutions for midwives. This study aimed to evaluate the adequacy of the examination-based licensing system and the possibility of a training-based licensing system.

METHODS: A survey questionnaire was developed and dispatched to 230 professionals from December 28, 2022 to January 13, 2023, through an online form using Google Surveys. Descriptive statistics were used to analyze the results.

RESULTS: Responses from 217 persons (94.3%) were analyzed after excluding incomplete responses. Out of the 217 participants, 198 (91.2%) agreed with maintaining the current examination-based licensing system; 94 (43.3%) agreed with implementing a training-based licensing system to cover the examination costs due to the decreasing number of applicants; 132 (60.8%) agreed with establishing a midwifery education evaluation center for a training-based licensing system; 163 (75.1%) said that the quality of midwifery might be lowered if midwives were produced only by a training-based licensing system, and 197 (90.8%) said that the training of midwives as birth support personnel should be promoted in Korea.

CONCLUSION: Favorable results were reported for the examination-based licensing system; however, if a training-based licensing system is implemented, it will be necessary to establish a midwifery education evaluation center to manage the quality of midwives. As the annual number of candidates for the Korean midwifery licensing examination has been approximately 10 in recent years, it is necessary to consider more actively granting midwifery licenses through a training-based licensing system.

PMID:37211982 | DOI:10.3352/jeehp.2023.20.15

Categories
Nevin Manimala Statistics

Pro-Con Debate: Interdisciplinary Perspectives on Industry-Sponsored Research

J Arthroplasty. 2023 Jun;38(6):986-991. doi: 10.1016/j.arth.2023.02.018.

ABSTRACT

PRO: Nearly all new devices and drugs come from industry that provides two-thirds of the funding for medical research, and a much higher fraction of clinical research. Realistically, without corporate-funded studies, perioperative research would stagnate with little innovation and few new products. Opinions are ubiquitous and normal but do not constitute epidemiologic bias. Competent clinical research includes many protections against selection and measurement bias, and the publication process provides at least moderate protection against misinterpretation of results. Trial registries largely prevent selective data presentation. Sponsored trials are particularly protected against inappropriate corporate influence because they are usually codesigned with the US Food and Drug Administration, and analyses are based on formal predefined statistical plans, as well as being conducted with rigorous external monitoring. Novel products, which are essential for advances in clinical care, largely come from industry, and industry appropriately funds much of the required research. We should celebrate industry’s contribution to improvements in clinical care. CON: While industry funding contributes to research and discovery, examples of industry-funded research demonstrate bias. In the setting of financial pressures and potential conflict of interest, bias can influence the type of study design, hypotheses being tested, rigor and transparency in data analysis, interpretation, as well as reporting of the results. Unlike public granting agencies, industry does not necessarily provide funding based on unbiased peer review following an open call for proposals. The focus on success can influence the choice of a comparator, which might not be ideal among the possible alternatives, the language used in the publication, and even the ability to publish. Unpublished negative trials can result in selected information being withheld from the scientific community and the public. Appropriate safeguards are needed to ensure that research addresses the most important and relevant questions, that results are available even when they do not support the use of a product produced by the funding company, that populations studied reflect the relevant patients, that the most rigorous approaches are applied, that studies have the appropriate power to address the question posed, and that conclusions are presented in an unbiased manner.

PMID:37211379 | DOI:10.1016/j.arth.2023.02.018

Categories
Nevin Manimala Statistics

RETINAL VASCULAR DENSITY CHANGE IN PATIENTS WITH HEART FAILURE

Photodiagnosis Photodyn Ther. 2023 May 19:103621. doi: 10.1016/j.pdpdt.2023.103621. Online ahead of print.

ABSTRACT

PURPOSE: The aim of this study is to assess choroid thickness, retinal vessel density in the superficial capillary plexus layer and deep capillary plexus layer in heart failure (HF) using optical coherence tomography angiography (OCT-A).

METHODS: 36 healthy participants (group 1), 33 patients with HF were assessed for this study. HF patients had a left ventricular ejection fraction (LVEF) <50%. HF patients were divided into 2 groups according to the New York Heart Association (NYHA). 15 patients were evaluated as group 2 according to NYHA and 18 patients as group 3 according to NYHA. Choroid thickness, superficial and deep capillary plexus perfusion were analyzed between groups using OCT-A.

RESULTS: Choroid thicknesses were found to be significantly decrease in the HF groups. Superficial capillary plexus density was compared with the control group, no statistically significant difference was found between the HF groups. But among the HF groups, a statistically significant decrease was found in group 3 patients. Deep capillary plexus density was compared with the control group, a statistically significant decrease was found in group 3. In addition, deep capillary plexus density a statistically significant difference was found between the groups HF.

CONCLUSIONS: Patients with HF showed decreased flow density compared with healthy controls. In addition, significant changes were found in flow densities among the HF groups. Retinal perfusion measured using OCT-A may give an idea about the hemodynamic status and microperfusion of HF patients.

PMID:37211295 | DOI:10.1016/j.pdpdt.2023.103621

Categories
Nevin Manimala Statistics

Comparing Recombinant Human Rabies Monoclonal Antibody (Ormutivimab) with Human Rabies Immunoglobulin (HRIG) for Postexposure Prophylaxis: A Phase 3, Randomized, Double-Blind, Non-inferiority Trial

Int J Infect Dis. 2023 May 19:S1201-9712(23)00569-6. doi: 10.1016/j.ijid.2023.05.017. Online ahead of print.

ABSTRACT

OBJECTIVES: To evaluate the immunogenicity and safety of an anti-rabies monoclonal antibody (mAb), Ormutivimab, compared with human rabies immunoglobulin (HRIG).

METHODS: This phase 3 trial was designed as a randomized, double-blind, non-inferiority clinical trial in patients aged ≥ 18 years with suspected WHO category Ⅲ rabies exposures. The participants were randomized 1:1 to Ormutivimab and HRIG group. After thorough wound washing and injection of Ormutivimab/HRIG on Day 0, the vaccination was administered on Days 0, 3, 7, 14, and 28. The primary endpoint was the adjusted geometric mean concentration (GMC) of rabies virus neutralizing activity (RVNA) on Day 7. The endpoint of safety included the occurrence of adverse reactions (ARs) and serious adverse events (SAEs).

RESULTS: A total of 720 participants were recruited. The adjusted-GMC of RVNA (0.41 IU/mL) on Day 7 in Ormutivimab group was not inferior to that in HRIG group (0.41 IU/mL), with ratio of adjusted-GMC of 1.01 (95%CI: 0.91, 1.14). The seroconversion rate of the Ormutivimab-group was higher than that of the HRIG-group on Days 7, 14, and 42. The majority of local injection site and systemic ARs reported from both groups were mild to moderate in severity.

CONCLUSIONS: Ormutivimab + vaccine can protect aged ≥ 18 years victims with category Ⅲ suspected rabies exposure as a component of post-exposure prophylaxis. Ormutivimab has a weaker influence on immunity response of rabies vaccines.

CLINICAL TRIALS REGISTRATION: ChiCTR1900021478 (the Chinese Clinical Trial Registry of WHO).

PMID:37211270 | DOI:10.1016/j.ijid.2023.05.017

Categories
Nevin Manimala Statistics

Short-Term Outcomes of Jones Specific Implant vs. Intramedullary Screw and Plate Fixation for Proximal Fifth Metatarsal Fractures

J Foot Ankle Surg. 2023 May 19:S1067-2516(23)00121-7. doi: 10.1053/j.jfas.2023.05.005. Online ahead of print.

ABSTRACT

Although intramedullary screw fixation is commonly performed for proximal fifth metatarsal fractures, high rates of nonunion, refracture, and hardware prominence have been reported. The Jones Specific Implant (JSI) is a novel surgical implant which contours to the native curvature of the fifth metatarsal allowing for a more anatomic fixation. The purpose of this study was to compare short-term complication rates and outcomes of patients treated with the JSI to other fixation types such as plates and intramedullary screws. Electronic records were queried for adult patients with proximal fifth metatarsal fractures who underwent primary fixation from 2010 – 2021. All patients were treated by a foot and ankle fellowship-trained surgeon with intramedullary screws, plates, or JSI (Arthrex Inc., Naples, FL). Visual analog scale (VAS) and the American Orthopedic Foot and Ankle Score (AOFAS) were recorded and compared using univariate statistics. Eighty-five patients underwent fixation using intramedullary screw (n=51, 60%), plate (n=22, 25.9%), or JSI (n=12, 14.1%) with a mean follow-up of 11.1±14.6 months. The total cohort demonstrated a significant improvement in VAS pain (p < 0.0001) as well as AOFAS (p < 0.0001) scores. When comparing the cohort treated with JSI and the cohort treated with all other types of fixation, there were no significant differences in postoperative VAS or AOFAS scores. Only three complications, one with JSI, (3.5%) required removal of the symptomatic hardware. The JSI is a novel treatment for proximal fifth metatarsal fractures, with similar early outcomes and complication rates when compared with intramedullary screw and plate fixation.

PMID:37211269 | DOI:10.1053/j.jfas.2023.05.005

Categories
Nevin Manimala Statistics

Mortality trends and disease burdens of cervical, endometrial and ovarian cancers from 1981 to 2020 in Taiwan

Prev Med. 2023 May 19:107551. doi: 10.1016/j.ypmed.2023.107551. Online ahead of print.

ABSTRACT

Cervical, endometrial, and ovarian cancers are major gynecologic cancers in Taiwan. Although cervical cancer has received attention through nationwide screening program and the rollout of the human papillomavirus vaccine, endometrial and ovarian cancers have attracted less attention. The age-period-cohort analysis of constant-relative-variation method was used to estimate the mortality trends of cervical, endometrial, and ovarian cancers for population aged 30-84 years during 1981-2020 in Taiwan. The years of life lost was used to estimate the disease burden due to premature death from gynecological cancers. The age effect of endometrial cancer mortality was greater than those of cervical and ovarian cancers. The period effects decreased during 1996-2000 for cervical cancer and plateaued for endometrial and ovarian cancers during 2006-2020. The cohort effect decreased after the birth year 1911 for cervical cancer, increased after 1931 for endometrial cancer, and increased in all birth years for ovarian cancer. For both endometrial and ovarian cancers, the Spearman’s correlation coefficients revealed the strong negative correlations between the fertility and the cohort effects, and the strong positive correlations between the average age at first childbirth and the cohort effects. The burden of premature death from ovarian cancer was higher than those of cervical and endometrial cancers during 2016-2020. Due to increasing cohort effect and burden of premature death, endometrial and ovarian cancers will become the largest threat to women’s reproductive health in Taiwan.

PMID:37211252 | DOI:10.1016/j.ypmed.2023.107551

Categories
Nevin Manimala Statistics

High Immunoglobulin-M Levels to Oxidation-Specific Epitopes Are Associated with Lower Risk of Acute Myocardial Infarction

J Lipid Res. 2023 May 19:100391. doi: 10.1016/j.jlr.2023.100391. Online ahead of print.

ABSTRACT

Immunoglobulin M (IgM) autoantibodies to oxidation-specific epitopes (OSE) can be present at birth and protect against atherosclerosis in experimental models. This study sought to determine whether high titers of IgM titers to OSE (IgM OSE) are associated with lower risk of acute myocardial infarction (AMI) in humans. IgM to malondialdehyde-low density lipoprotein (MDA-LDL), phosphocholine-modified bovine serum albumin (PC-BSA), IgM apolipoprotein B100-immune complexes (ApoB-IC) and a peptide mimotope of malondialdehyde (MDA) were measured within 24 hours of first AMI in 4559 patients and 4617 age and sex-matched controls in the Pakistan Risk of Myocardial Infarction Study. Adjustment was made for sex, age, smoking, hypertension, diabetes, LDL-C, HDL-C, and triglycerides. Logistic regression was used to estimate odds ratio (OR) and 95% confidence interval (95% CI) for AMI. All four IgM OSE were lower in AMI versus controls (p<0.001 for all). Males, smokers and individuals with hypertension and diabetes had lower levels of all 4 IgM OSE compared to unaffected individuals (p<0.001 for all). Compared to the lowest quintile, the highest quintiles of IgM MDA-LDL, PC-BSA, ApoB-IC, and MDA mimotope P1 had lower OR of AMI: OR (95% (CI)] of 0.67 (0.58-0.77), 0.64 (0.56-0.73), 0.70 (0.61-0.80) and 0.72 (0.62-0.82) (p<0.001 for all], respectively. Upon addition of IgM OSE to conventional risk factors, the C-statistic improved by 0.0062 (0.0028-0.0095) and net reclassification by 15.5% (11.4-19.6). These findings demonstrate that IgM OSE provide clinically meaningful information and support the hypothesis that higher levels of IgM OSE may be protective against AMI.

PMID:37211249 | DOI:10.1016/j.jlr.2023.100391

Categories
Nevin Manimala Statistics

Efficacy and safety of interleukin-6 inhibition with ziltivekimab in patients at high risk of atherosclerotic events in Japan (RESCUE-2): A randomized, double-blind, placebo-controlled, phase 2 trial

J Cardiol. 2023 May 19:S0914-5087(23)00112-0. doi: 10.1016/j.jjcc.2023.05.006. Online ahead of print.

ABSTRACT

BACKGROUND: Despite optimal treatment, a residual inflammatory risk often remains in patients with atherosclerotic cardiovascular disease. In a US-based phase 2 trial, ziltivekimab, a fully human monoclonal antibody targeting the interleukin-6 ligand, significantly reduced biomarkers of inflammation compared with placebo in patients at high atherosclerotic risk. Here, we report the efficacy and safety of ziltivekimab in Japanese patients.

METHODS: RESCUE-2 was a randomized, double-blind, 12-week, phase 2 trial. Participants aged ≥20 years with stage 3-5 non-dialysis-dependent chronic kidney disease and high-sensitivity C-reactive protein (hsCRP) ≥2 mg/L were randomized to receive placebo (n = 13) or subcutaneous ziltivekimab 15 mg (n = 11) or 30 mg (n = 12) at Weeks 0, 4, and 8. The primary endpoint was percentage change in hsCRP levels from baseline to end of treatment (EOT; mean of Week 10 and Week 12 values).

RESULTS: At EOT, median hsCRP levels were reduced by 96.2 % in the 15 mg group (p < 0.0001 versus placebo), by 93.4 % in the 30 mg group (p = 0.002 versus placebo), and by 27.0 % in the placebo group. Serum amyloid A and fibrinogen levels were also reduced significantly. Ziltivekimab was well tolerated and did not affect total cholesterol to high-density lipoprotein cholesterol ratios. There was a small, but statistically significant increase in triglyceride levels with ziltivekimab 15 mg and 30 mg compared with placebo.

CONCLUSIONS: The efficacy and safety results support the development of ziltivekimab for secondary prevention and the treatment of patients at high atherosclerotic risk.

CLINICALTRIALS: gov identifier, NCT04626505.

PMID:37211246 | DOI:10.1016/j.jjcc.2023.05.006

Categories
Nevin Manimala Statistics

The development of a risk-adjustment strategy to benchmark emergency medical service (EMS) performance in relation to out-of-hospital cardiac arrest in Australia and New Zealand

Resuscitation. 2023 May 19:109847. doi: 10.1016/j.resuscitation.2023.109847. Online ahead of print.

ABSTRACT

INTRODUCTION: The aim of this study was to develop a risk adjustment strategy, including effect modifiers, for benchmarking emergency medical service (EMS) performance for out-of-hospital cardiac arrest (OHCA) in Australia and New Zealand.

METHOD: Using 2017-2019 data from the Australasian Resuscitation Outcomes Consortium (Aus-ROC) OHCA Epistry, we included adults who received an EMS attempted resuscitation for a presumed medical OHCA. Logistic regression was applied to develop risk adjustment models for event survival (return of spontaneous circulation at hospital handover) and survival to hospital discharge/30 days. We examined potential effect modifiers, and assessed model discrimination and validity.

RESULTS: Both OHCA survival outcome models included EMS agency and the Utstein variables (age, sex, location of arrest, witnessed arrest, initial rhythm, bystander cardiopulmonary resuscitation, defibrillation prior to EMS arrival, and EMS response time). The model for event survival had good discrimination according to the concordance statistic (0.77) and explained 28% of the variation in survival. The corresponding figures for survival to hospital discharge/30 days were 0.87 and 49%. The addition of effect modifiers did little to improve the performance of either model.

CONCLUSION: The development of risk adjustment models with good discrimination is an important step in benchmarking EMS performance for OHCA. The Utstein variables are important in risk-adjustment, but only explain a small proportion of the variation in survival. Further research is required to understand what factors contribute to the variation in survival between EMS.

PMID:37211232 | DOI:10.1016/j.resuscitation.2023.109847

Categories
Nevin Manimala Statistics

Chain-mediating effect of interaction between telomeres and mitochondria under oxidative stress in coke oven workers

Environ Pollut. 2023 May 19:121855. doi: 10.1016/j.envpol.2023.121855. Online ahead of print.

ABSTRACT

Coke oven emissions (COEs) exposure leads to oxidative stress, an imbalance between oxidant production and antioxidant defence in the body, which then leads to shortened relative telomere length (RTL) and reduced mitochondrial DNA copy number (mtDNAcn), ultimately leading to ageing and disease. By analysing the relationship among COEs, oxidative stress, RTL and mtDNAcn, we investigated the chain-mediating effects of oxidative stress and telomeres on mitochondrial damage and mitochondria on telomere damage in coke oven workers. A total of 779 subjects were included in the study. Cumulative COEs exposure concentrations were estimated, and the RTL and mtDNAcn of peripheral blood leukocytes were measured using real-time fluorescence quantitative PCR. Total antioxidant capacity (T-AOC) was measured to reflect the level of oxidative stress. The data were statistically analysed using SPSS 21.0 software and discussed using mediation effect analysis. After adjusting for age, sex, smoking, drinking and BMI, generalised linear model revealed dose-response associations between COEs and T-AOC, RTL and mtDNAcn, respectively. (Ptrend < 0.05). The results of chain-mediating effect showed that the proportion of the chain-mediating effect of “CED-COEs→T-AOC→ RTL→mtDNAcn” was 0.82% (β = -0.0005, 95% CI = [-0.0012, -0.0001]), and the proportion of the chain-mediating effect of “CED-COEs→T-AOC→ mtDNAcn → RTL ″ was 2.64% (β = -0.0013, 95% CI = [-0.0025, -0.0004]). After oxidative stress is induced by COEs, mitochondria and telomeres may interact with each other while leading further to potential bodily damage. This study provides clues to explore the association between mitochondria and telomeres.

PMID:37211230 | DOI:10.1016/j.envpol.2023.121855