Impact of COVID-19 on patterns of drug utilization: A case study at national hospital

by Minh-Anh Le-Dang, Hai-Yen Nguyen-Thi, Luyen Pham Dinh, Danh Le Ngoc, Nguyen Dang Tu Le, Hien Pham Thu, Dinh Thanh Le

Background

The Coronavirus disease of 2019 (COVID-19) pandemic and the corresponding mitigation measures have had a discernible impact on drug utilization among outpatients. However, limited research exists on the prescription trends in the elderly population during the pandemic period in Viet Nam.

Objectives

This study aims to analyze the effects of COVID-19 on outpatient drug utilization patterns at a national geriatric hospital in Ho Chi Minh City before and after the early onset of the pandemic.

Methods

Data was collected from the prescriptions and administration claims, encompassing the period from January 2016 to December 2022. The dataset was divided into two periods: Period 1: January 2016 to December 2020 and Period 2: January 2021 to December 2022. The drug utilization was measured using DDD/1000P (defined daily doses–DDD per 1000 prescriptions) on a monthly basis. The analysis employed interrupted time series using Autoregressive Integrated Moving Average (ARIMA) to detect changes in drug use levels and rates.

Results

A total of 1,060,507 and 644,944 outpatient prescriptions from Thong Nhat Hospital were included in Period 1 and Period 2, respectively. The median age of the patients were 58 in Period 1 and 67 years old in Period 2. The most common comorbidities were dyslipidemia, hypertension, and diabetes mellitus. In terms of medication utilization, cardiovascular drugs were the most frequently prescribed, followed by drugs active on the digestive and hormonal systems. The study observed significant surges in the number of prescriptions and the average number of drugs per prescription. However, there were no significant changes in the overall consumption of all drugs. Among the drug groups related to the cardiovascular system, three subgroups experienced a sudden and significant increase: cardiac therapy, beta-blocking agents, and antihypertensives, with increasing consumption levels of 1,177.73 [CI 95%: 79.29; 2,276.16], 73.32 [CI 95%: 28.18; 118.46], and 36.70 [CI 95%: 6.74; 66.66] DDD/1000P, respectively. On the other hand, there was a significant monthly decrease of -31.36 [CI 95%: -57.02; -5.70] DDD/1000P in the consumption of anti-inflammatory and antirheumatic products. Interestingly, there was a significant increase of 74.62 [CI 95%: -0.36; 149.60] DDD/1000P in the use of antigout preparations.

Conclusion

COVID-19 resulted in a sudden, non-significant increase in overall drug consumption levels among outpatients. Notably, our findings highlight significant increases in the utilization of three drug groups related to the cardiovascular system, specifically cardiac therapy, beta-blocking agents, and antihypertensives. Intriguingly, there was a statistically significant increase in the consumption of antigout preparations, despite a decline in the monthly consumption rate of non-steroidal anti-flammatory drugs (NSAIDs). Further studies in the following years are necessary to provide a more comprehensive understanding of the impact of COVID-19 on outpatient drug utilization patterns.

Nutrient density of Bangladeshi foods and its application in planning diet for pregnant women

by Nazma Shaheen, Abira Nowar, Saiful Islam, Md. Hafizul Islam, Md. Ruhul Amin

Nutrient profiling is a method that classifies foods based on their nutrient content and identifies foods that are high in micronutrients both across and within food groups. This study aimed to identify foods that are rich sources of the seven micronutrients (iron, zinc, calcium, thiamine, riboflavin, vitamin A, and vitamin B₁₂) of public health concern for the Bangladeshi population._. This study developed a metric termed “naturally nutrient-rich score 7 (NNR₇)” specifically for third-trimester pregnant women to identify nutrient-dense foods. Further, it computed the nutrient adequacy score (NAS) of the top NNR₇-scored foods for seven micronutrients to assess the extent (percent) to which foods can meet pregnant women’s recommended dietary allowances (RDA). A linear programming technique was then used to construct a nutrient-adequate model diet for third-trimester pregnant women using the top ten NNR₇-scored foods. According to the NNR₇, food groups such as leafy vegetables, fish, meat, poultry and eggs, and vegetables are the richest sources of the problem micronutrients. Mutton liver (916.7%), soybean (39.3%), lamb liver (2160%) and duck liver (50.0%) were found to fulfill the highest percentage of the RDA of vitamin A, zinc, vitamin B_12, and iron, respectively. In the formulated nutrient-adequate diets for pregnant women, rice, potato, brown wheat flour, and soya oil were universal to all three diets and Bengal gram, orange, Ganges River sprat, and duck liver were the most common ones. The study findings highlight the need for the consumption of foods such as leafy vegetables, fish, meat, poultry, eggs, pulses and vegetables to increase the intake of problematic micronutrients. Planning a nutrient-adequate diet for pregnant women using linear programming can be an alternative approach to optimize and shape food choices to meet their nutritional requirements.

Metabolomic signature between diabetic and non-diabetic obese patients: A protocol for systematic review

by Yuxing Tai, Xiaoqian Yang, Xiaochao Gang, Zhengri Cong, Sixian Wang, Peizhe Li, Mingjun Liu

Background

Type 2 diabetes mellitus (T2DM) is a chronic and progressive condition defined by hyperglycemia caused by abnormalities in insulin production, insulin receptor sensitivity, or both. Several studies have revealed that higher body mass index (BMI) is associated with increasing risk of developing diabetes. In this study, we perform a protocol for systematic review to explore metabolite biomarkers that could be used to identify T2DM in obese subjects.

Methods

The protocol of this review was registered in PROSPERO (CRD42023405518). Three databases, EMBASE, PubMed, and Web of Science were selected to collect potential literature from their inceptions to July December 2023. Data for collection will include title, authors, study subjects, publication date, sample size, detection and analytical platforms, participant characteristics, biological samples, confounding factors, methods of statistical analysis, the frequency and directions of changes in potential metabolic biomarkers, and major findings. Pathway analysis of differential metabolites will be performed with MetaboAnalyst 5.0 based on the Kyoto Encyclopedia of Genes and Genomes (KEGG) and the Human Metabolome Database.

Results

The results of this systematic review will be published in a peer-reviewed journal.

Conclusion

This systematic review will summarize the potential biomarkers and metabolic pathways to provide a new reference for the prevention and treatment of T2DM in obese subjects.

Global perspectives of determinants influencing HPV vaccine introduction and scale-up in low- and middle-income countries

by Dominique Guillaume, Dur-e-Nayab Waheed, Meike Schleiff, Kirthini Kasi Muralidharan, Alex Vorsters, Rupali J. Limaye

Achieving WHO cervical cancer elimination goals will necessitate efforts to increase HPV vaccine access and coverage in low-and-middle-income countries (LMICs). Although LMICs account for the majority of cervical cancer cases globally, scale-up of HPV vaccine programs and progress toward coverage targets in LMICs has been largely insufficient. Understanding the barriers and facilitators that stakeholders face in the introduction and scale-up of HPV vaccination programs will be pivotal in ensuring that LMICs are equipped to optimize the implementation of HPV vaccination programs. This qualitative study interviewed 13 global stakeholders categorized as either academic partners or global immunization partners to ascertain perspectives regarding factors affecting the introduction and scale-up of HPV vaccination programs in LMICs. Global stakeholders were selected as their perspectives have not been as readily highlighted within the literature despite their key role in HPV vaccination programming. The results of this investigation identified upstream (e.g., financial considerations, vaccine prioritization, global supply, capacity and delivery, and vaccine accessibility, equity, and ethics) and downstream (e.g., vaccine acceptability and hesitancy, communications, advocacy, and social mobilization) determinants that impact program introduction and scale-up and confirmed that strong political commitment and governance are significant in garnering support for HPV vaccines. As LMICs introduce HPV vaccines into their national immunization programs and develop plans for scaling up vaccination efforts, strategic approaches to communications and advocacy will also be needed to successfully meet coverage targets.

Occurrence and characteristics of extended-spectrum-β-lactamase- and pAmpC-producing <i>Klebsiella pneumoniae</i> isolated from companion animals with urinary tract infections

by Megan Min Yi Lee, Nan-Ling Kuan, Zhi-Yi Li, Kuang-Sheng Yeh

This study examined 70 Klebsiella pneumoniae isolates derived from companion animals with urinary tract infections in Taiwan. Overall, 81% (57/70) of the isolates carried extended-spectrum β-lactamase (ESBL) and/or plasmid-encoded AmpC (pAmpC) genes. ESBL genes were detected in 19 samples, with bla_CTX-M-1, bla_CTX-M-9, and bla_SHV being the predominant groups. pAmpC genes were detected in 56 isolates, with bla_CIT and bla_DHA being the predominant groups. Multilocus sequence typing revealed that sequence types (ST)11, ST15, and ST655 were prevalent. wabG, uge, entB, mrkD, and fimH were identified as primary virulence genes. Two isolates demonstrated a hypermucoviscosity phenotype in the string test. Antimicrobial susceptibility testing exhibited high resistance to β-lactams and fluoroquinolones in ESBL-positive isolates but low resistance to aminoglycosides, sulfonamides, and carbapenems. Isolates carrying pAmpC genes exhibited resistance to penicillin-class β-lactams. These findings provide valuable insights into the role of K. pneumoniae in the context of the concept of One Health.

Intraorbital pressure–volume characteristics in a piglet model: In vivo pilot study

by Yasin Hamarat, Laimonas Bartusis, Vilma Putnynaite, Rolandas Zakelis, Mantas Deimantavicius, Vilma Zigmantaite, Ramunė Grigaleviciute, Audrius Kucinskas, Evaldas Kalvaitis, Arminas Ragauskas

Intracranial pressure measurement is frequently used for diagnosis in neurocritical care but cannot always accurately predict neurological deterioration. Intracranial compliance plays a significant role in maintaining cerebral blood flow, cerebral perfusion pressure, and intracranial pressure. This study’s objective was to investigate the feasibility of transferring external pressure into the eye orbit in a large-animal model while maintaining a clinically acceptable pressure gradient between intraorbital and external pressures. The experimental system comprised a specifically designed pressure applicator that can be placed and tightly fastened onto the eye. A pressure chamber made from thin, elastic, non-allergenic film was attached to the lower part of the applicator and placed in contact with the eyelid and surrounding tissues of piglets’ eyeballs. External pressure was increased from 0 to 20 mmHg with steps of 1 mmHg, from 20 to 30 mmHg with steps of 2 mmHg, and from 30 to 50 mmHg with steps of 5 mmHg. An invasive pressure sensor was used to measure intraorbital pressure directly. An equation was derived from measured intraorbital and external pressures (intraorbital pressure = 0.82 × external pressure + 3.12) and demonstrated that external pressure can be linearly transferred to orbit tissues with a bias (systematic error) of 3.12 mmHg. This is close to the initial intraorbital pressure within the range of pressures tested. We determined the relationship between intraorbital compliance and externally applied pressure. Our findings indicate that intraorbital compliance can be controlled across a wide range of 1.55 to 0.15 ml/mmHg. We observed that external pressure transfer into the orbit can be achieved while maintaining a clinically acceptable pressure gradient between intraorbital and external pressures.

Association between vitamin D and endometriosis among American women: National Health and Nutrition Examination Survey

by Baoli Xie, Ming Liao, Yingqin Huang, Fu Hang, Nana Ma, Qianwen Hu, Jiawei Wang, Yufu Jin, Aiping Qin

Endometriosis is a multifactorial disease associated with inflammation. Vitamin D has anti-inflammatory, antiproliferative, anti-oxidative, and immunomodulatory effects. Whether vitamin D levels are correlated with endometriosis is a subject of ongoing debate. This study aimed to examine the association between endometriosis and serum vitamin D levels. From the National Health and Nutrition Examination Survey, this study examined the cross-sectional data of American women aged 20–54 years from 2001 to 2006. After adjusting for covariates, multivariable logistic regression analysis was used to assess correlations. A total of 3,232 women were included in this study. The multiple linear regression model demonstrated a negative correlation between the serum 25-hydroxyvitamin D3 (cholecalciferol) concentration and the risk of endometriosis after controlling for all confounding variables. The odds ratio was 0.73 with a 95% confidence interval of 0.54–0.97 in the adequate vitamin D level group compared with the insufficient vitamin D level group. Our results showed that endometriosis was inversely correlated with serum 25-hydroxyvitamin D3 levels. Further research is needed to establish a causal relationship and determine the potential benefits of maintaining sufficient vitamin D levels for endometriosis prevention.

Nasopharyngeal carriage of <i>Streptococcus pneumoniae</i> among children <5 years of age in Indonesia prior to pneumococcal conjugate vaccine introduction

by Dodi Safari, Wa Ode Dwi Daningrat, Jennifer L. Milucky, Miftahuddin Majid Khoeri, Wisiva Tofriska Paramaiswari, Wisnu Tafroji, Korrie Salsabila, Yayah Winarti, Amin Soebandrio, Sri Rezeki Hadinegoro, Ari Prayitno, Lana Childs, Fabiana C. Pimenta, Maria da Gloria Carvalho, Tamara Pilishvili

Pneumococcal conjugate vaccines (PCVs) prevent nasopharyngeal colonization with vaccine serotypes of Streptococcus pneumoniae, leading to reduced transmission of pneumococci and stronger population-level impact of PCVs. In 2017 we conducted a cross-sectional pneumococcal carriage study in Indonesia among children aged

Effect of probiotics or prebiotics on thyroid function: A meta-analysis of eight randomized controlled trials

by Qinxi Shu, Chao Kang, Jiaxin Li, Zhenzhu Hou, Minfen Xiong, Xingang Wang, Hongyan Peng

Background

Microbiome-directed therapies are increasingly utilized to optimize thyroid function in both healthy individuals and those with thyroid disorders. However, recent doubts have been raised regarding the efficacy of probiotics, prebiotics, and synbiotics in improving thyroid function. This systematic review aimed to investigate the potential relationship between probiotics/prebiotics and thyroid function by analyzing the impact on thyroid hormone levels.

Methods

We conducted a comprehensive systematic review and meta-analysis of randomized controlled trials that investigated the effects of probiotics, prebiotics, and synbiotics on free triiodothyronine (fT3), free thyroxine (fT4), thyroid stimulating hormone (TSH), and thyroid stimulating hormone receptor antibody (TRAb) levels. We searched for articles from PubMed, Scopus, Web of Science, and Embase up until April 1st, 2023, without any language restriction. Quantitative data analysis was performed using a random-effects model, with standardized mean difference (SMD) and 95% confidence interval as summary statistics. The methods and results were reported according to the PRISMA2020 statement.

Results

A total of eight articles were included in this review. The meta-analysis showed no significant alterations in TSH (SMD: -0.01, 95% CI: −0.21, 0.20, P = 0.93; I²: 0.00%), fT4 (SMD: 0.04, 95% CI: −0.29, 0.21, P = 0.73; I²: 0.00%) or fT3 (SMD: 0.45, 95% CI: −0.14, 1.03, P = 0.43; I²: 78.00%), while a significant reduction in TRAb levels was observed (SMD: -0.85, 95% CI: -1.54, -0.15, P = 0.02; I²: 18.00%) following probiotics/prebiotics supplementation. No indication of publication bias was found.

Conclusions

Probiotics/prebiotics supplementation does not influence thyroid hormone levels, but may modestly reduce TRAb levels in patients with Graves’ disease.

Stress and burnout amongst mental health professionals in Singapore during Covid-19 endemicity

by Suyi Yang, Germaine Ke Jia Tan, Kang Sim, Lucas Jun Hao Lim, Benjamin Yong Qiang Tan, Abhiram Kanneganti, Shirley Beng Suat Ooi, Lue Ping Ong

The COVID-19 pandemic has exerted a huge emotional strain on mental health professionals (MHP) in Singapore. As Singapore transited into an endemic status, it is unclear whether the psychological strain has likewise lessened. The aims of this study were to investigate the levels of stress and burnout experienced by MHP working in a tertiary psychiatric hospital in Singapore during this phase of COVID-19 endemicity (2022) in comparison to the earlier pandemic years (2020 and 2021) and to identify factors which contribute to as well as ameliorate stress and burnout. A total of 282 MHP participated in an online survey in 2022, which included 2 validated measures, namely the Perceived Stress Scale and the Oldenburg Burnout Inventory (OLBI). Participants were also asked to rank factors that contributed the most to their stress and burnout. Between-group comparisons were conducted regarding stress and burnout levels among MHP across different demographic groupings and working contexts. In addition, OLBI data completed by MHP in 2020 and 2021 were extracted from 2 published studies, and trend analysis was conducted for the proportion of MHP meeting burnout threshold across 3 time points. We found that the proportion of MHP meeting burnout threshold in 2020, 2021 and 2022 were 76.9%, 87.6% and 77.9% respectively. Professional groups, age, years of experience and income groups were associated with stress and/or burnout. High clinical workload was ranked as the top factor that contributed to stress and burnout while flexible working arrangement was ranked as the top area for improvement so as to reduce stress and burnout. As such, policy makers and hospital management may want to focus on setting clear mental health targets and facilitate manageable clinical workload, build manpower resiliency, optimize resources and provide flexible work arrangements to alleviate stress and burnout among MHP.

Towards system redesign: An exploratory analysis of neurodivergent traits in a childhood population referred for autism assessment

by Jason Lang, Georgia Wylie, Caroline Haig, Christopher Gillberg, Helen Minnis

Background

Children’s health services in many countries are moving from single condition diagnostic silo assessments to considering neurodevelopment in a more holistic sense. There has been increasing recognition of the importance of clinical overlap and co-occurrence of different neurotypes when assessing neurodivergent children. Using a cross-sectional service evaluation design, we investigated the overlap of neurodivergences in a cohort of children referred for autism assessment, focusing on motor, learning, and attention/activity level domains. We aimed to determine what proportion of children in a cohort referred for an autism assessment showed traits of additional neurodivergences, and what proportion were further investigated.

Methods

We evaluated anonymised medical records of children aged between two and 17 years referred for autism assessment. We used validated questionnaires to assess for neurodivergent traits. A weighted scoring system was developed to determine traits in each neurodevelopmental domain and a score above the median was considered to indicate a neurodivergent trait. Evidence of further investigations were recorded. We then examined the relationships between autism traits and traits of additional neurodivergence.

Results

114 participants were included for evaluation. 62.3% (n = 71) had completed questionnaires for analysis. Of these, 71.8% (n = 51) scored greater than the median for at least one additional neurotype, indicating the presence of other neurodivergent traits, and 88.7% (n = 64) attracted a diagnosis of autism. Only 26.3% of children with evidence of additional neurotypes were further investigated beyond their autism assessment.

Conclusions

Our results demonstrate the extensive overlap between additional neurodivergent traits in a population of children referred with suspected autism and show that only a small proportion were further investigated. The use of standardised questionnaires to uncover additional neurodivergences may have utility in improving the holistic nature of neurodevelopmental assessments.

Efficacy of early cardiac rehabilitation after acute myocardial infarction: Randomized clinical trial protocol

by Caroline Schon, Amanda Felismino, Joceline de Sá, Renata Corte, Tatiana Ribeiro, Selma Bruno

The acute myocardial infarction (AMI) present high mortality rate that may be reduced with cardiac rehabilitation. Despite its good establishment in outpatient care, few studies analyzed cardiac rehabilitation during hospitalization. Thus, this study aims to clarify the safety and efficacy of early cardiac rehabilitation after AMI. This will be a clinical, controlled, randomized trial with blind outcome evaluation and a superiority hypothesis. Twenty-four patients with AMI will be divided into two groups (1:1 allocation ratio). The intervention group will receive an individualized exercise-based cardiac rehabilitation protocol during hospitalization and a semi-supervised protocol after hospital discharge; the control group will receive conventional care. The primary outcomes will be the cardiac remodeling assessed by cardiac magnetic resonance imaging, functional capacity assessed by maximal oxygen consumption, and cardiac autonomic balance examined via heart rate variability. Secondary outcomes will include safety and the total exercise dose provided during the protocol. Statistical analysis will consider the intent-to-treat analysis. Trial registration. Trial registration number: Brazilian Registry of Clinical Trials (ReBEC) (RBR- 9nyx8hb).

Screening for antibacterial and cytotoxic activities of Sri Lankan marine sponges through microfractionation: Isolation of bromopyrrole alkaloids from <i>Stylissa massa</i>

by Lakmini Kosgahakumbura, Jayani Gamage, Luke P. Robertson, Taj Muhammad, Björn Hellman, Ulf Göransson, Prabath Jayasinghe, Chamari Hettiarachchi, Paco Cárdenas, Sunithi Gunasekera

Sri Lanka is a biodiversity hotspot and one of the richest geographical locations of marine sponges in the Indian ocean. However, the most extensive taxonomical study on Sri Lankan sponge biodiversity dates back ~100 years and only a limited number of studies have been conducted on sponge natural products. In the current study, 35 marine sponge specimens (collected from 16 sponge habitats around Sri Lanka) were identified, microfractionated and evaluated for antibacterial and anticancer assays. In total, 30 species were characterized, of which 19 species gave extracts with antibacterial and/or cytotoxic activities. Microfractionated organic extract of Aciculites orientalis gave the most potent antibacterial activity against Staphylococcus aureus and strongest lymphoma cell toxicity was exhibited by the organic extract of Acanthella sp. Guided by the molecular ion peaks in the bioactive fractions, large-scale extraction of Stylissa massa led to the isolation of three bromopyrrole alkaloids, sceptrin, hymenin and manzacidin A/C. Of these, sceptrin exhibited broad spectrum antibacterial activity against both Escherichia coli and S. aureus (MIC of 62.5 μM against both species). Based on natural product literature, seven promising species were identified as understudied. Their further exploration may lead to the discovery of structurally novel compounds.

Trends in obesity, leisure-time physical activity, and sedentary behavior in Korean adults: Korea national health and nutritional examinations survey from 2014 to 2021

by Yunmin Han, Hoyong Sung, Younghwan Choi, Yeon Soo Kim

Objectives

This study aimed to investigate trends in obesity by dividing it based on body mass index (BMI) and waist circumference indicators, sedentary behavior, and leisure-time physical activity (LTPA) in Korean adults from 2014 to 2021. This study also aimed to determine the adherence rate of people with obesity to physical activity.

Methods

Data from the Korea National Health and Nutritional Examination Survey (KNHANES) from 2014 to 2021 were used. A total of 42,676 participants 19 years or older were included in the final analysis. Sociodemographic characteristics, anthropometric measurements, and physical activity levels were recorded. Physical activity levels were assessed using the Global Physical Activity Questionnaire, a self-reported questionnaire. Multivariable logistic regression analysis adjusted for covariates was used to investigate the prevalence of obesity and sitting time or adherence to meeting the physical activity guidelines for each survey year.

Results

This study included 42,676 adults. The weighted prevalence of obesity in all ages significantly increased from 30.8% (29.1%-32.5%) in 2014 to 34.5% (32.9%-36.2%) in 2017 and 37.3% (35.5%-39.1%) in 2021 (p for trend p for trend p for trend Conclusion

From 2014 to 2021, obesity and sedentary behavior significantly increased and adherence to LTPA decreased among Korean adults. Given these concerning trends, comprehensive interventions are needed at the national level to encourage healthy lifestyle behaviors.

Efficacy of preoperative lymphoscintigraphy in predicting surgical outcomes of lymphaticovenous anastomosis in lower extremity lymphedema: Clinical correlations in gynecological cancer-related lymphedema

by Min Young Yoo, Kyong-Je Woo, Seo Young Kang, Byung Seok Moon, Bom Sahn Kim, Hai-Jeon Yoon

Background

Lymphaticovenous anastomosis (LVA) is a promising microsurgical treatment for lower extremity lymphedema (LEL). Lymphoscintigraphy effectively assesses lower limb lymphatic systems before LVA, but its role in predicting the therapeutic outcomes of LVA is indeterminate. In this study we investigate the efficacy of preoperative lymphoscintigraphy using clinical findings to predict outcomes in gynecological cancer-related LEL patients who underwent LVA.

Methods

A retrospective review was conducted on consecutive gynecological cancer patients with LEL who had undergone LVA between June 2018 and June 2021. The therapeutic efficacy was assessed by measuring the change rate of the lower extremity lymphedema index (LELi) six months after surgery. Clinical data and lymphoscintigraphic findings were analyzed to assess therapeutic efficacy of LVA.

Results

Out of the 60 evaluated legs, 83.3% of the legs showed improved results after LVA. Univariable linear regression analysis revealed that higher preoperative LELi, and ovarian cancer were associated with superior LELi change rate (LC rate). Absence of dermal backflow (DBF) on lymphoscintigraphy was associated with inferior LC rate. Multivariable linear regression analysis identified ovarian cancer and higher preoperative LELi were independently correlated with favorable outcomes, while the absence of DBF was independently correlated with inferior outcomes.

Conclusion

The results of this study emphasizes the effectiveness of preoperative lymphoscintigraphy, preoperative LELi, and primary malignancy as predictors of LVA outcomes in gynecological cancer-related LEL patients.

Gait analysis: An effective tool to mechanically monitor the bone regeneration of critical-sized defects in tissue engineering applications

by Pablo Blázquez-Carmona, Juan Mora-Macías, Juan Morgaz, María del Mar Granados, Jaime Domínguez, Esther Reina-Romo

Introduction

Tissue engineering has emerged as an innovative approach to treat critical-size bone defects using biocompatible scaffolds, thus avoiding complex distraction surgeries or limited stock grafts. Continuous regeneration monitoring is essential in critical-size cases due to the frequent appearance of non-unions. This work evaluates the potential clinical use of gait analysis for the mechanical assessment of a tissue engineering regeneration as an alternative to the traditional and hardly conclusive manual or radiological follow-up.

Materials and methods

The 15-mm metatarsal fragment of eight female merino sheep was surgically replaced by a bioceramic scaffold stabilized with an external fixator. Gait tests were performed weekly by making the sheep walk on an instrumented gangway. The evolution of different kinematic and dynamic parameters was analyzed for all the animal’s limbs, as well as asymmetries between limbs. Finally, potential correlation in the recovery of the gait parameters was evaluated through the linear regression models.

Results

After surgery, the operated limb has an altered way of carrying body weight while walking. Its loading capacity was significantly reduced as the stance phases were shorter and less impulsive. The non-operated limbs compensated for this mobility deficit. All parameters were normalizing during the consolidation phase while the bone callus was simultaneously mineralizing. The results also showed high levels of asymmetry between the operated limb and its contralateral, which exceeded 150% when analyzing the impulse after surgery. Gait recovery significantly correlated between symmetrical limbs.

Conclusions

Gait analysis was presented as an effective, low-cost tool capable of mechanically predicting the regeneration of critical-size defects treated by tissue engineering, as comparing regeneration processes or novel scaffolds. Despite the progressive normalization as the callus mineralized, the bearing capacity reduction and the asymmetry of the operated limb were more significant than in other orthopedic alternatives.

Nutrition fact label (NFL) use is related to meeting the requirements for vitamins and minerals not listed on NFLs: Data from the Korea National Health and Nutritional Examination Survey VIII (2019–2021) for the prepandemic and pandemic periods

by Jung Min Cho

The credibility and wide usability of nutrition fact labels (NFLs) have increased due to the pandemic, which may lead to healthier nutritional choices. This cross-sectional study aimed to evaluate the association between NFL use and meeting the estimated average requirements (EARs) for vitamins and minerals not listed on NFLs during the prepandemic (2019, n = 6606) and pandemic periods (2020 and 2021, n = 12085) using KNHANES data. Household surveys, health behavior interviews, and health checkup examinations were conducted for all participants. Subjects were included in the unAware+noUse, Aware+noUse, and Aware+Use groups according to NFL usage, and nutritional intake was analyzed by the 24-hour recall method. Complex-sample multiple logistic regression analysis was used to determine the odds ratios (ORs) and 95% confidence intervals (CIs) for meeting the EARs according to NFL usage in the crude and adjusted (including metabolic conditions) models. The primary finding was that awareness and NFL use were associated with adequate intake above the EARs for vitamin A, vitamin B₂, niacin, folate, Ca, Fe, and P; this association was more evident during the pandemic. After adjusting for covariates, during the pandemic, the ORs of meeting the EARs in the Aware+noUse group and Aware+Use group were 1.25 (CI 1.06–1.47) and 1.36 (CI 1.05–1.75) for vitamin A, 1.26 (CI 1.06–1.50) and 1.54 (CI 1.19–2.00) for vitamin B₂, 1.32 (CI 1.13–1.56) and 1.46 (CI 1.15–1.85) for folate, and 1.46 (CI 1.06–2.00) and 1.73 (1.09–2.75) for P, respectively. Additionally, the ORs for niacin (1.21, 1.02–1.43) and Fe (1.29, 1.08–1.54) were significant in the Aware+noUse group, and that for Ca (1.39, 1.08–1.78) was significant in the Aware+Use group (all p

Impact of cognitive behavioral therapy on premature ejaculation patients: A prospective, randomized controlled trial protocol

by Qiyun Yang, Hongcai Cai, Zi Wan, Min Chen, Bicheng Yang, Yun Xie, Yadong Zhang, Xiangzhou Sun, Jia Tang, Ming Kuang, Hongying Liu, Chunhua Deng

Background

Premature ejaculation (PE) is one of the most common male sexual dysfunctions, with a prevalence of about 4%-39% in the Chinese population. Studies have shown that a variety of biological factors can lead to premature ejaculation, such as central nervous system disorders, hypersensitivity of the penis head, and psychological factors. Based on clinical experience, psychological counseling and education of patients and partners should be ranked as the first priority when treating PE. Cognitive behavioral therapy (CBT) addresses emotional, behavioral, and cognitive disorders by altering beliefs and actions. It has also been demonstrated to be clinically useful in treating a number of diseases. The purpose of this trial is to evaluate the efficacy of a mobile-based CBT intervention on patients with PE compared to conventional routine treatment.

Methods

This study is a prospective randomized controlled trial that will be conducted from May 2023 to Dec 2024 at ten hospitals, primarily including the First Affiliated Hospital of Sun Yat-sen University with an 8-week follow-up. The clinical trial central randomization system will be used to create and implement the specific randomization method. Baseline data of both groups will be measured and collected. The premature ejaculation diagnostic tool (PEDT) and the female sexual distress scale-revised for premature ejaculation (FSDS-R-PE) will be collected on the first day, 28±2 days, and 56±2 days during the intervention period, and the intravaginal ejaculatory latency time (IELT) will be measured in both groups. The Shapiro-Wilk test will be used for normality testing. Pearson correlation analysis will be used for correlation analysis. Differences between groups will be compared using analysis of variance or exact probability calculations.

Discussion

This study will investigate the effect of a mobile-based CBT intervention on patients with PE.

Trial registration

Chinese Clinical Trial Registry (ChiCTR2300070581).

Impact of an intervention program on drug adherence in patients with ulcerative colitis: Randomized clinical trial

by Mila Pacheco, Pedro Sá, Gláucia Santos, Ney Boa-Sorte, Kilma Domingues, Larissa Assis, Marina Silva, Ana Oliveira, Daniel Santos, Jamile Ferreira, Rosemeire Fernandes, Flora Fortes, Raquel Rocha, Genoile Santana

Aims

Evaluate the impact of an intervention program in non-adherent patients with ulcerative colitis.

Methods

Parallel controlled randomized clinical trial (1:1), approved by the ethics committee (No. 3.068.511/2018) and registered at The Brazilian Clinical Trials Registry (No. RBR-79dn4k). Non-adherent ulcerative colitis patients according to the Morisky-Green-Levine-test were included. Recruitment began in August 2019 until August 2020, with 6-month follow-up. All participants received standard usual care, and additionally the intervention group received educational (video, educational leaflet, verbal guidance) and behavioral interventions (therapeutic scheme, motivational and reminder type short message services). Researchers were blinded for allocation prior to data collection at Visits 1 and 2 (0 and 6 months). Primary outcome: 180-day adherence rate, with relative risk 95%CI. Secondary outcome: 180-day quality of life according to SF-36 domains, using Student’s t test. Variables with p Results

Forty-six and 49 participants were allocated in control and intervention groups, respectively. Two were excluded due to intervention refusal, and 4 and 6 were lost to follow-up in control and intervention groups. There was no post-intervention adherence rate difference, even after adjustment for type of non-adherence (unintentional/both/intentional) as confounder, or if considered as adherent the intervention group participants lost in follow-up. Interventions promoted better quality of life scores even after multivariate analysis for “Pain”, when adjusted for ulcerative colitis severity, sex, and marital status (β = 18.352, p = 0.004), “Vitality”, when adjusted for ulcerative colitis severity (β = 10.568, p = 0.015) and “Emotional Aspects”, when adjusted for disease severity, income, and education (β = 24.907, p = 0.041).

Conclusions

The intervention program was not able to produce a significant medication adherence rate difference between comparative groups, however, there was a significant improvement in quality of life. Study limitations may include: sample size calculated to identify differences of 30%, leading to a possible insufficient power; non blinded participants, exposing the results to the risk of performance bias; outcomes based on self-reported data.

Can phone surveys be representative in low- and middle-income countries? An application to Myanmar

by Isabel Lambrecht, Joanna van Asselt, Derek Headey, Bart Minten, Patrick Meza, Moe Sabai, Thet Su Sun, Hnin Ei Win

For decades, in-person data collection has been the standard modality for nationally and sub-nationally representative socio-economic survey data in low- and middle-income countries. As the COVID-19 pandemic rendered in-person surveys impossible and unethical, the urgent need for rapid monitoring necessitated researchers and statistical agencies to turn to phone surveys. However, apart from pandemic-related factors, a variety of other reasons can render large segments of a population inaccessible for in-person surveys, including political instability, climatic shocks, and remoteness. Such circumstances currently prevail in Myanmar, a country facing civil conflict and political instability since the February 2021 military takeover. Moreover, Myanmar routinely experiences extreme weather events and is characterized by numerous inaccessible and remote regions due to its mountainous geography. We describe a novel approach to sample design and statistical weighting that has been successfully applied in Myanmar to obtain nationally and sub-nationally representative phone survey data. We use quota sampling and entropy weighting to obtain a better geographical distribution compared to recent in-person survey efforts, including reaching respondents in areas of active conflict. Moreover, we minimize biases towards certain household and respondent characteristics that are usually present in phone surveys, for example towards well-educated or wealthy households, or towards men or household heads as respondents. Finally, due to the rapidly changing political and economic situation in Myanmar in 2022, the need for frequent and swift monitoring was critical. We carried out our phone survey over four quarters in 2022, interviewing more than 12,000 respondents in less than three months each survey. A survey of this scale and pace, though generally of much shorter duration than in-person interviews, could only be possible on the phone. Our study proves the feasibility of collecting nationally and sub nationally representative phone survey data using a non-representative sample frame, which is critical for rapid monitoring in any volatile economy.