bluuebunny/crossref_metadata_2025 huggingface dataset:
Cost-Effectiveness Analysis of Hearing Aids for Middle-Aged and Older Adults in China: A Randomized Controlled Trial
Authors: Ye Xin , Zhu Dawei , Chen Siyuan , He Ping
Published: June 2023

Objective

To assess the cost-effectiveness of hearing aid interventions to middle-aged and older adults in rural China.

Study Design

Randomized controlled trial.

Setting

Community centers.

Patients

A total of 385 subjects 45 years and older with moderate or above hearing loss participated in the trial, of which 150 were in the treatment group and 235 in the control group.

Intervention

Participants were randomly assigned to the treatment group prescribing with hearing aids or to the control group with no intervention.

Main Outcome and Measures

The incremental cost-effectiveness ratio was calculated by comparing the treatment group with the control group.

Results

Assuming that the average life span of hearing aids is N years, the cost of the hearing aid intervention included the annual purchase cost of 10,000/N yuan, the annual maintenance cost of 41.48 yuan. However, the intervention led to annual healthcare costs of 243.34 yuan saved. The effectiveness of wearing a hearing aid included an increase of 0.017 quality-adjusted life years. It can be calculated that if N > 6.87, the intervention is very cost-effective; if 2.52 < N < 6.87, the increased cost-effectiveness of the intervention is acceptable; if N < 2.52, the intervention is not cost-effective.

Conclusion

In general, the average life span of hearing aids is between 3 and 7 years, so hearing aid interventions can be considered cost-effective with high probability. Our results can provide critical reference for policy makers to increase accessibility and affordability of hearing aids.
Nutrition therapy during noninvasive ventilation: oral or enteral?
Authors: Viner Smith Elizabeth , D’Cruz Rebecca F. , Chapple Lee-anne
Published: June 2023

Purpose of review

Critical care nutrition guidelines primarily focus on patients receiving invasive mechanical ventilation, yet noninvasive ventilation (NIV) is an increasingly common intervention. The optimal route of nutrition delivery in patients receiving NIV has not been established. This review aims to describe the implications of NIV on the route of feeding prescribed.

Recent findings

Five small, mostly observational, studies have quantified energy or protein intake in patients receiving NIV in critical care, which demonstrate intake to be poor. No study has assessed the impact of feeding route on outcomes. The predominant route of feeding observed is oral intake, yet nutrition intake via this route is lower than that from enteral or parenteral nutrition. Barriers to oral intake include fasting for intubation, the inability to remove NIV apparatus to eat, breathlessness, fatigue and poor appetite, while barriers to enteral nutrition include the impact of the naso-enteric tube on the mask seal and potential aspiration.

Until evidence to support the optimal route of feeding is developed, patient safety should be the key driver of route selection, followed by the ability to achieve nutrition targets, perhaps utilizing a combination of routes to overcome barriers to nutrition delivery.
Post-ICU nutrition: the neglected side of metabolic support
Authors: De Waele Elisabeth , Rosseel Zenzi , Pen Joeri J.
Published: June 2023

Purpose of this review

This review will focus on the neglected side of metabolic support in ICU survivors: nutritional therapy after critical illness. Knowledge of the evolution of the metabolism of patients that survived critical illness will be bundled, and current practices will be investigated. We will discuss some studies conducted to determine resting energy expenditure in ICU survivors and which identified barriers that cause interruptions in the feeding process based on published data between January 2022 and April 2023.

Recent findings

Resting energy expenditure can be measured using indirect calorimetry, as predictive equations have proven to fail in their attempt to have good correlations with measured values. No guidelines or recommendations are available on post-ICU follow-up, including screening, assessment, dosing, timing, and monitoring of (artificial) nutrition. A limited number of publications shared treatment adequacy between 64–82% for energy (calories) and 72–83% for protein intake in a post-ICU setting. Loss of appetite, depression, and oropharyngeal dysphagia are the most prominent physiological barriers responsible for decreased feeding adequacy.

Patients may be in a catabolic state during and after ICU discharge, with several factors impacting metabolism. Therefore, large prospective trials are needed to determine the physiological state of ICU survivors, determine nutritional requirements, and develop nutritional care protocols. Many barriers causing decreased feeding adequacy have already been identified, but solutions are scarce. This review depicts a variable metabolic rate among ICU survivors and a significant variation in feeding adequacy in-between world regions, institutions, and patient sub-phenotypes.
Lipid emulsions in parenteral nutrition: does it matter?
Authors: Haines Krista , Grisel Braylee , Gorenshtein Laura , Wischmeyer Paul E.
Published: June 2023

Purpose of review

Recently, clinicians have shown interest in switching patients to nonsoybean-based intravenous lipid emulsion (ILE) formulas for parental nutrition (PN) due to adverse outcomes related to high Omega-6 content in soybean oil (SO) ILE's. This review summarizes recent literature on improved clinical outcomes with new Omega-6 lipid-sparing ILE's in PN management.

Recent findings

Although there is a paucity of large-scale studies directly comparing Omega-6 lipid sparing ILE's with SO-based lipid emulsion use in PN in ICU patients, there is strong translational and meta-analysis evidence to suggest that lipid formulations containing fish oil (FO) and/or olive oil (OO) have favorable effects on immune function and improve clinical outcomes in ICU populations.

More research is needed to directly compare omega-6-sparing PN formulas with FO and/or OO versus traditional SO ILE's. However, current evidence is promising for improved outcomes using newer ILE's including reduced infections, shorter lengths of stay, and reduced costs.
Is there a role for ketones as alternative fuel in critical illness?
Authors: Watson Naomi , McClelland Thomas J. , Puthucheary Zudin
Published: June 2023

Purpose of review

The evidence base advocating ketones as an alternative substrate for critically ill patients is expanding. We discuss the rationale for investigating alternatives to the traditional metabolic substrates (glucose, fatty acids and amino acids), consider evidence relating to ketone-based nutrition in a variety of contexts, and suggest the necessary future steps.

Recent findings

Hypoxia and inflammation inhibit pyruvate dehydrogenase, diverting glucose to lactate production. Skeletal muscle beta-oxidation activity falls, decreasing acetyl-CoA generation from fatty acids and subsequent ATP generation reduction.

The benefits of induced ketosis are well established in epilepsy, whilst the evidence base for ketogenic diet therapy in other neurological pathology, such as traumatic brain injury and neurodegenerative diseases, is expanding. Evidence of upregulation of ketone metabolism in the hypertrophied and failing heart suggests that ketones may be utilized as an alternative fuel source to sustain myocardial function. Ketogenic diets stabilize immune cell homeostasis, promote cell survival following bacterial infection and inhibit the NLRP3 inflammasome, preventing the release of pro-inflammatory cytokines – interleukin (IL)-1β and IL-18.

Whilst ketones provide an attractive nutritional option, further research is required to determine whether the proposed benefits are translatable to critically unwell patients.
Haematological challenges in cardiogenic shock
Authors: Van Edom Charlotte J. , Tavazzi Guido , Vandenbriele Christophe
Published: June 2023

Purpose of review

Cardiogenic shock (CS) remains a very challenging condition with high mortality, despite the advances in therapeutic options. Haematological complications, including coagulopathy and haemolysis, frequently arise in these critically ill patients in CS, especially if they need percutaneous mechanical circulatory support (pMCS), and impair the outcome. This stresses the urgent need for further advancement of this field.

Recent findings

Here, we discuss the different haematological challenges during CS and additional pMCS. Furthermore, we propose a management strategy aiming for restabilization of this precarious haemostatic balance.

In this review, pathophysiology and management of coagulopathies during CS and pMCS are discussed, as well as the need for further studies in this field.
Development and Feasibility of a Group Tele-Exercise Program for Individuals With Spinal Cord Injury
Authors: Baehr Laura A. , Kaimal Girija , Bruneau Michael , Finley Margaret
Published: June 2023

Background and Purpose:

More than 50% of individuals with spinal cord injury (SCI) report no regular exercise due to numerous barriers to participation. Tele-exercise services offer viable solutions to reduce barriers. However, limited evidence for SCI-specific tele-exercise programs is available. The purpose of this study was to evaluate the feasibility of a synchronous group tele-exercise program designed for individuals with SCI.

Methods:

Explanatory sequential mixed-methods design assessed feasibility of a synchronous 2-month biweekly group tele-exercise program for individuals with SCI. Numeric measures of feasibility were first collected (recruitment rate, sample features, retention, attendance), followed by postprogram interviews with participants. Thematic analysis of experiential feedback elaborated on numeric findings.

Results:

Eleven volunteers (ages = 49.5 ± 16.7 years) with SCI (range: 2.7-33.0 years) enrolled within 2 weeks of recruitment initiation. Retention was 100% retention at program completion. Median number of live classes attended per participant was 10 (62.5%). Participants described that attendance and satisfaction were facilitated by program-specific features including coinstruction by instructors with SCI-specific knowledge and lived experience, as well as group structure. Participants reported increased exercise knowledge, confidence, and motivation.

Discussion and Conclusions:

This study demonstrated feasibility of a synchronous group tele-exercise class for individuals with SCI. Key features facilitating participation include class length, frequency, coleadership by individuals familiar with SCI and exercise instruction, and group motivation. These findings begin to examine a viable tele-service strategy that could be employed as a bridge among rehabilitation specialists, community fitness instructors, and clients with SCI to increase physical activity access and behavior.

Video Abstract available for more insights from the authors (see the Video, Supplemental Digital Content 1 available at: http://links.lww.com/JNPT/A442).
Role of Rib Graft for Tip Shaping in Primary Rhinoplasty: A Retrospective Case Series of 30 Patients
Authors: Novak Matthew , Cason Roger , Rohrich Rod J.
Published: June 2023

Background:

In primary rhinoplasty, use of harvested septal cartilage often precludes the need for rib graft. Nonetheless, there are a number of indications for the use of rib graft in primary rhinoplasty. The purpose of this study was to identify the indications and techniques for rib graft use in primary rhinoplasty.

Methods:

A retrospective review was performed on all patients who underwent primary rhinoplasty performed by a single surgeon over a 5-year period. From these patients, those who required the use of fresh frozen allograft rib cartilage were identified. Medical record review was performed to identify demographics, ethnicity, and history of nasal trauma. Photographic analysis was also performed.

Results:

Thirty of 638 consecutive primary rhinoplasties (4.7%) required rib graft. Of these, 7 patients (23.3%) demonstrated a history of nasal trauma. Furthermore, a high proportion of primary rhinoplasty patients requiring rib graft were from Asian (n = 7 [23.3%]), Middle Eastern (n = 4 [13.3%]), Hispanic (n = 7 [23.3%]), and African American (n = 9 [30%]) backgrounds. White patients were in the minority (n = 2 [6.7%]). All primary rhinoplasties using rib graft implemented a septal extension graft.

Conclusions:

The present study demonstrates that patients requiring a rib graft in primary rhinoplasty invariably receive a septal extension graft. Furthermore, certain ethnicities associated anatomical characteristics correlated with the need for a rib graft for tip shaping. Ultimately, the use of a septal extension graft in primary rhinoplasty allows for precise and robust projection, rotation, and tip shaping in noses with thick skin, weak cartilaginous framework, and history of nasal trauma.

CLINICAL QUESTION/LEVEL OF EVIDENCE:

Risk, IV.
Long-Term Effects of Extended Upper Blepharoplasty Combined With Subbrow Skin Removal for Correction of Lateral Hooding in Asian Women
Authors: Li Si L. , Li Kong Y. , Song Tao , Di Wu  , Yin Ning B. , Wang Yong Q.
Published: June 2023

Upper eyelid aging with lateral hooding is common among Asian women older than 40 years. Since Asians tend to develop more visible scars than White people, we used an extended upper blepharoplasty technique to correct lateral hooding and conceal the scar, combined with the removal of the thick subbrow skin for women over 60 years of age, to achieve a stable, improved outcome. An extended cutaneous scalpel-shaped excision was designed and hid the extended part of the excision in the patient’s upward crow’s feet to address the redundant skin of lateral hooding. For patients older than 60 years, we used a crescent-shaped excision and simultaneously removed the thick skin under the eyebrow to reduce the likelihood of long-term postoperative pseudoexcess. A retrospective study was conducted on 40 Asian women who underwent upper eyelid rejuvenation surgery with the above methods from July 2020 to March 2021 (follow-up, 12–15 mo). Extended blepharoplasty notably corrected the lateral hooding and achieved a natural double eyelid. The postoperative scar was inconspicuous. For patients older than 60 years, the long-term rejuvenation outcome was stable when associated with subbrow skin removal. However, two patients older than 60 years in whom the subbrow skin was not removed developed pseudoexcess of the upper eyelid 1 year postoperatively. Extended blepharoplasty is a simple and effective technique for improving periorbital aging in Asian women, and the postoperative scarring was inconspicuous. For patients older than 60 years, we recommend removal of the thick subbrow skin to avoid long-term postoperative pseudoexcess.
Comparison of 2 Incisional Methods in Hair Transplantation
Authors: Chen Lulu , Wang Bo , Liu Xiaona , Yang Jiadong , Jiang Wenjie
Published: June 2023

Hair transplantation has been an effective technique for facial contour modification. Hair follicular units (FU) harvested from scalp strip is the gold-standard method for hair transplantation. The difference in obtaining FU from different shapes of scalp strips is not clear yet. Follicular units of 127 patients were harvested from scalp strip through parallelogram incision or fusiform incision from October 2017 to January 2020. The number of FU in 1 cm2 scalp strip were calculated and paired t test were used to compare the difference in hair follicle acquirement rate between 2 incisions. The number and acquisition rate of FU by parallelogram incision were significantly higher than that by fusiform incision. Therefore, parallelogram incision might be more suitable to harvest FU for hair transplantation surgery.
Utility of Regional Maxillary Nerve Blocks in Improving Cleft Palate Postoperative Outcomes
Authors: Jacobs-El Hannah , Samuel Ankhita , Chen Xizhao , Yemen Terrance , Gampper Thomas , Black Jonathan
Published: June 2023

Background:

Palatoplasty procedures used to repair cleft palates are commonly associated with limiting postoperative pain. Regional anesthetic blocks have been utilized to improve pain outcomes and decrease opioid intake, yet additional data is needed to fully explore its utility in this setting.

Objective:

To explore whether ultrasound-guided suprazygomatic maxillary blocks (SMB) improve postoperative pain, postoperative opioid use, time to oral feeding, and length of stay compared with a palatal field block in cleft palate repair.

Methods:

In this retrospective chart review, 47 patients aged 9 to 25 months who underwent cleft palate repair between 2013 and 2020 were allocated into 2 groups: a control group where patients received only palatal local anesthetic in a field block fashion (N=29), and Maxillary block group who received ultrasound-guided SMB (N=18). Patients were matched by age and cleft Veau type. The primary outcomes were total postoperative morphine equivalent consumption, average pain scores, length of stay, and time to first oral feed.

Results:

Comparing field block versus SMB groups, there was not a statistical difference in the overall dose of postoperative morphine equivalent opioid administration (11.71 vs. 13.36 mg; P=0.483), average pain scores (5.78 vs. 5.27; P=0.194), time to first oral feed [17.21 vs. 14.48 h; P=0.407, 95% CI: (−3.85, 9.32)] or length of stay (P=0.292).

Conclusion:

The use of SMBs did not demonstrate a difference in the postoperative outcomes evaluated by this study. Further study is needed to define its utility in cleft palate repair
Diet- and salinity-induced modifications of the gut microbiota are associated with differential physiological responses to ranavirus infection in
Rana sylvatica
Authors: Hughey Myra C. , Warne Robin , Dulmage Alexa , Reeve Robyn E. , Curtis Grace H. , Whitfield Kourtnie , Schock Danna M. , Crespi Erica
Published: June 2023

Greater knowledge of how host–microbiome interactions vary with anthropogenic environmental change and influence pathogenic infections is needed to better understand stress-mediated disease outcomes. We investigated how increasing salinization in freshwaters (e.g. due to road de-icing salt runoff) and associated increases in growth of nutritional algae influenced gut bacterial assembly, host physiology and responses to ranavirus exposure in larval wood frogs (
Rana sylvatica
). Elevating salinity and supplementing a basic larval diet with algae increased larval growth and also increased ranavirus loads. However, larvae given algae did not exhibit elevated kidney corticosterone levels, accelerated development or weight loss post-infection, whereas larvae fed a basic diet did. Thus, algal supplementation reversed a potentially maladaptive stress response to infection observed in prior studies in this system. Algae supplementation also reduced gut bacterial diversity. Notably, we observed higher relative abundances of Firmicutes in treatments with algae—a pattern consistent with increased growth and fat deposition in mammals—that may contribute to the diminished stress responses to infection via regulation of host metabolism and endocrine function. Our study informs mechanistic hypotheses about the role of microbiome mediation of host responses to infection that can be tested in future experiments in this host–pathogen system.

This article is part of the theme issue ‘Amphibian immunity: stress, disease and ecoimmunology’.
The amphibian immune system
Authors: Ruiz Vania Lopez , Robert Jacques
Published: June 2023

Amphibians are at the forefront of bridging the evolutionary gap between mammals and more ancient, jawed vertebrates. Currently, several diseases have targeted amphibians and understanding their immune system has importance beyond their use as a research model. The immune system of the African clawed frog,
Xenopus laevis
, and that of mammals is well conserved. We know that several features of the adaptive and innate immune system are very similar for both, including the existence of B cells, T cells and innate-like T cells. In particular, the study of the immune system at early stages of development is benefitted by studying
X. laevis
tadpoles. The tadpoles mainly rely on innate immune mechanisms including pre-set or innate-like T cells until after metamorphosis. In this review we lay out what is known about the innate and adaptive immune system of
X. laevis
including the lymphoid organs as well as how other amphibian immune systems are similar or different. Furthermore, we will describe how the amphibian immune system responds to some viral, bacterial and fungal insults.

This article is part of the theme issue ‘Amphibian immunity: stress, disease and ecoimmunology’.
Selection of an anti-pathogen skin microbiome following prophylaxis treatment in an amphibian model system
Authors: Siomko Samantha A. , Greenspan Sasha E. , Barnett K. M. , Neely Wesley J. , Chtarbanova Stanislava , Woodhams Douglas C. , McMahon Taegan A. , Becker C. Guilherme
Published: June 2023

With emerging diseases on the rise, there is an urgent need to identify and understand novel mechanisms of prophylactic protection in vertebrate hosts. Inducing resistance against emerging pathogens through prophylaxis is an ideal management strategy that may impact pathogens and their host-associated microbiome. The host microbiome is recognized as a critical component of immunity, but the effects of prophylactic inoculation on the microbiome are unknown. In this study, we investigate the effects of prophylaxis on host microbiome composition, focusing on the selection of anti-pathogenic microbes contributing to host acquired immunity in a model host–fungal disease system, amphibian chytridiomycosis. We inoculated larval
Pseudacris regilla
against the fungal pathogen
Batrachochytrium dendrobatidis
(
Bd
) with a
Bd
metabolite-based prophylactic. Increased prophylactic concentration and exposure duration were associated with significant increases in proportions of putatively
Bd
-inhibitory host-associated bacterial taxa, indicating a protective prophylactic-induced shift towards microbiome members that are antagonistic to
Bd.
Our findings are in accordance with the adaptive microbiome hypothesis, where exposure to a pathogen alters the microbiome to better cope with subsequent pathogen encounters. Our study advances research on the temporal dynamics of microbiome memory and the role of prophylaxis-induced shifts in microbiomes contributing to prophylaxis effectiveness.

This article is part of the theme issue ‘Amphibian immunity: stress, disease and ecoimmunology’.
Amphibian infection tolerance to chytridiomycosis
Authors: Grogan Laura F. , Mangan Madelyn J. , McCallum Hamish I.
Published: June 2023

Animal defences against infection involve two distinct but complementary mechanisms: tolerance and resistance. Tolerance measures the animal's ability to limit detrimental effects from a given infection, whereas resistance is the ability to limit the intensity of that infection. Tolerance is a valuable defence for highly prevalent, persistent or endemic infections where mitigation strategies based on traditional resistance mechanisms are less effective or evolutionarily stable. Selective breeding of amphibians for enhanced tolerance to
Batrachochytrium
spp
.
has been suggested as a strategy for mitigating the impacts of the fungal disease, chytridiomycosis. Here, we define infection tolerance and resistance in the context of chytridiomycosis, present evidence for variation in tolerance to chytridiomycosis, and explore epidemiological, ecological and evolutionary implications of tolerance to chytridiomycosis. We found that exposure risk and environmental moderation of infection burdens are major confounders of resistance and tolerance, chytridiomycosis is primarily characterized by variation in constitutive rather than adaptive resistance, tolerance is epidemiologically important in driving pathogen spread and maintenance, heterogeneity of tolerance leads to ecological trade-offs, and natural selection for resistance and tolerance is likely to be dilute. Improving our understanding of infection tolerance broadens our capacity for mitigating the ongoing impacts of emerging infectious diseases such as chytridiomycosis.

This article is part of the theme issue ‘Amphibian immunity: stress, disease and ecoimmunology’.
Performance of ChatGPT and Bard in Self-Assessment Questions for Nephrology Board Renewal
Authors: Noda Ryunosuke , Izaki Yuto , Kitano Fumiya , Komatsu Jun , Ichikawa Daisuke , Shibagaki Yugo
Published: June 2023

Background

Large language models (LLMs) pretrained on vast amounts of data have significantly influenced recent advances in artificial intelligence. While GPT-4 has demonstrated high performance in general medical examinations, its performance in specialised areas such as nephrology is unclear. This study aimed to compare ChatGPT and Bard and their potential clinical applications in nephrology.

Methods

Ninety-nine questions from the Self-Assessment Questions for Nephrology Board Renewal from 2018 to 2022 were presented to two versions of ChatGPT (GPT-3.5 and GPT-4) and Bard. We calculated the overall correct answer rates for the five years, each year, and question categories and checked whether they exceeded the pass criterion. The correct answer rates were compared with those of the nephrology residents.

Results

The overall correct answer rates for GPT-3.5, GPT-4, and Bard were 31.3% (31/99), 54.5% (54/99), and 32.3% (32/99), respectively, thus GPT-4 demonstrated significantly higher performance than GPT-3.5 (p < 0.01) and Bard (p < 0.01). GPT-4 met the passing criteria in three years. GPT-4 demonstrated significantly higher performance in problem-solving, clinical, and non-image questions than GPT-3.5 and Bard. The correct answer rate for GPT-4 was intermediate between the rates for third- and fourth-year nephrology residents.

Conclusions

GPT-4 significantly outperformed GPT-3.5 and Bard and met the Nephrology Board renewal standards in three of five years. These findings underline the potential applications of LLMs in nephrology as well as their advantages and disadvantages. As LLMs advance, nephrologists must understand their performance and reliability for future applications.
Identifying older adults at risk for Alzheimer’s Disease based on smartphone data obtained during wayfinding in the real world
Authors: Marquardt Jonas , Mohan Priyanka , Spiliopoulou Myra , Glanz Wenzel , Butryn Michaela , Kuehn Esther , Schreiber Stefanie , Maass Anne , Diersch Nadine
Published: June 2023

Alzheimer’s disease (AD), as a leading cause for disability and death in old age, represents a major burden to healthcare systems worldwide. For the development of disease-modifying interventions and treatments, the detection of cognitive changes at the earliest disease stages is crucial. Recent advancements in mobile consumer technologies provide new opportunities to collect multi-dimensional data in real-life settings to identify and monitor at-risk individuals. Based on evidence showing that deficits in spatial navigation might constitute one of the earliest AD symptoms, we assessed whether older adults who report subjective cognitive decline (SCD) but score normally on neuropsychological assessments show differences in smartphone-assisted wayfinding behavior compared with cognitively healthy older and younger adults. Guided by a mobile application, participants had to find locations along a short route on the medical campus of the Magdeburg university. We show that performance measures that were extracted from GPS and user input data distinguish between the groups. In particular, the number of orientation stops was predictive of the SCD status in older participants. Our data suggest that cognitive changes, associated with an elevated AD risk, can be inferred from smartphone data, collected during a brief episode of an everyday behavior.
Standardization of drug names in the FDA Adverse Event Reporting System: The DiAna dictionary
Authors: Fusaroli Michele , Giunchi Valentina , Battini Vera , Puligheddu Stefano , Khouri Charles , Carnovale Carla , Raschi Emanuel , Poluzzi Elisabetta
Published: June 2023

Introduction

The FDA Adverse Event Reporting System (FAERS) receives drug names in various forms, including brand names, active ingredients, abbreviations, and misspellings, which creates challenges in nomenclature standardization. The lack of consensus on standardization strategies and of transparency hampers replicability and accuracy in conducting disproportionality analysis using FAERS data.

Aim

We have developed an open-source drug-to-ingredient dictionary called the DiAna dictionary (short for Disproportionality Analysis). Additionally, we have linked the DiAna dictionary to the WHO Anatomic Therapeutic Chemical (ATC) classification system.

Methods

We retrieved all drug names reported to the FAERS from 2004 to December 2022. Using existing dictionaries such as RxNorm and string editing techniques, we automatically translated the drug names to active ingredients. Manual revision was performed to correct errors and improve translation accuracy. The resulting DiAna dictionary was linked to the ATC classification, proposing a primary ATC code for each ingredient.

Results

We retrieved 18,151,842 reports, with 74,143,411 drug entries. We automatically translated and manually checked the first 14,832 terms, up to terms occurring at least 200 times (96.88% of total drug entries), to 6,282 unique active ingredients. Automatic unchecked translations extend the standardization to 346,854 terms (98.94%). After linking to the ATC classification, the most prominent drug classes in FAERS reports were immunomodulating (37.40%) and nervous system drugs (29.19%).

Conclusion

We present the DiAna dictionary as an open-source tool and encourage experts to provide input and feedbacks. Regular updates can improve research quality and promote a common pharmacovigilance toolbox, ultimately advancing safety and improving study interpretability.

Key points

Drug name standardization impacts signal detection accuracy.

DiAna dictionary cleanses drugs in FAERS for improved data control.

DiAna’s transparency and flexibility improves interpretability.
Exposure to Noise and Cardiovascular Disease in a Nationwide US Prospective Cohort Study of Women
Authors: Roscoe Charlotte , T. Grady Stephanie , Hart Jaime E. , Iyer Hari S. , Manson JoAnn E. , Rexrode Kathryn M. , Rimm Eric B. , Laden Francine , James Peter
Published: June 2023

Background:Long-term noise exposure is associated with cardiovascular disease (CVD), including acute cardiovascular events such as myocardial infarction and stroke. However, longitudinal cohort studies of long-term noise and CVD are almost exclusively from Europe, and few modelled nighttime and daytime noise separately. We aimed to examine the prospective association of outdoor long-term nighttime and daytime noise from anthropogenic sources with incident CVD using a US-based, nationwide cohort of women.

Methods:We linked L50 (median) nighttime and L50 daytime modelled anthropogenic noise estimates from a US National Park Service model to geocoded residential addresses of 114,116 participants in the Nurses’ Health Study. We used time-varying Cox proportional hazards models to estimate risk of incident CVD, coronary heart disease (CHD), and stroke associated with long-term average noise exposure, adjusted for potential individual- and area-level confounders and CVD risk factors (1988-2018). We assessed effect modification by population density, region, air pollution, vegetation cover, and neighborhood socioeconomic status, and explored mediation by self-reported average nightly sleep duration.

Results:Over 2,544,035 person-years, there were 10,331 incident CVD events. In fully-adjusted models, the hazard ratios for each interquartile range increase in L50 nighttime noise (3.67 dBA) and L50 daytime noise (4.35 dBA), respectively, were 1.04 (95% CI 1.02, 1.06) and 1.04 (95% CI 1.02, 1.07). Similar associations were observed for CHD and stroke. Stratified analyses suggested that associations of nighttime and daytime noise with CVD did not differ by prespecified effect modifiers. We found no evidence that inadequate sleep (< 5 hours per night) mediated associations of noise and CVD.

Discussion:Outdoor median nighttime and daytime noise at the residential address was associated with a small increase in CVD risk in a cohort of adult female nurses.
CLASS - CiaoLApo Stillbirth Support checklist: adherence to stillbirth guidelines and women’s psychological well-being
Authors: Ravaldi Claudia , Roper Francesca , Mosconi Laura , Vannacci Alfredo
Published: June 2023

Background

Stillbirth is a global public health issue affecting millions of parents and healthcare professionals. Quality and consistency of bereavement care after stillbirth are crucial for parents’ well-being, but they depend on the implementation and impact of international guidelines.

Aim

This study aimed to validate practices for stillbirth care by means of the CiaoLapo Stillbirth Support (CLASS) checklist, a tool that summarises the common elements of the main international guidelines on bereavement care after stillbirth, and to explore their association with women’s satisfaction, respectful care, and psychological outcomes.

Methods

A cross-sectional online survey was conducted among 261 women who experienced a stillbirth in the last 10 years in Italy, a country without official national guidelines. The survey included the CLASS checklist, the Perinatal Grief Scale, the National Stressful Events Survey PTSD Short Scale, and questions on satisfaction and respectful care.

Findings

The mean score of adherence to guidelines was low, 2.0 (SD 1.1, on a 4-point scale), with regional differences. The lowest scores were in respect for the baby, communication about funeral and autopsy, creating memories, and aftercare. Adherence to at least 40 out of 60 CLASS checklist items was independently associated with greater satisfaction and respectful care, and lower grief and posttraumatic stress symptoms.

Conclusion

The study shows that women who receive care that adheres to stillbirth guidelines have a better psychological outcome, with lower levels of grief and posttraumatic stress symptoms. The study also highlights the need for official national guidelines and adequate training and support for healthcare professionals in countries where they are lacking.
Regulation of Medical Devices in Zimbabwe: A qualitative study with key stakeholders
Authors: Chiku Charles , Maruta Talkmore , Mbiba Fredrick , Manasa Justen
Published: June 2023

Introduction

Medical devices play a crucial role in promoting public health. However, there is a disparity in the availability and readiness of medical device regulations in Resource-Limited Settings (RLS) compared to the global average. We conducted a study to explore the medical device regulation landscape and stakeholder perceptions in Zimbabwe.

Methodology

Between June and November 2022, we administered questionnaires to representatives of the Medicines Control Authority of Zimbabwe (MCAZ), the Medical Laboratory and Clinical Scientists Council of Zimbabwe (MLCScCZ), and the National Microbiology Reference Laboratory (NMRL). We also conducted semi-structured interviews with 12 national-level critical stakeholders from these institutions to understand the current status of medical device regulations and the relationships between them. Additionally, we interviewed regulators from the South African Health Products Regulatory Authority, Tanzania, and World Health Organisation to learn about best practices in transitioning to medical device regulations. We used a thematic approach and an inductively developed common coding framework to analyse emerging themes.

Results

Our findings indicate that the current legal framework needs to be revised to regulate medical devices effectively, as it does not specify the institution(s) responsible for regulating them. While the MCAZ regulates condoms and gloves, the MLCScCZ coordinates with the NMRL to register In Vitro Diagnostic Medical Devices for priority diseases. Other medical devices are not regulated. Furthermore, conformity assessments for product registration are not proportional to the risk classification of medical devices, and post-market surveillance activities are ineffective. Stakeholders recognise the need to collaborate and improve the regulation of medical devices.

Conclusion

Zimbabwe must improve its regulatory framework for medical devices to ensure that safe medical devices of acceptable quality and performance are accessible. A solid legal foundation is necessary for harmonisation and reliance practices to reduce the regulatory burden on economic operators and ease the workload on regulators.
Multimodal Pain Recognition in Postoperative Patients: A Machine Learning Approach
Authors: Subramanian Ajan , Cao Rui , Naeni Emad Kasaeyan , Aqajari Syed Amir Hossein , Hughes Thomas D. , Calderon Michael-David , Zheng Kai , Dutt Nikil , Liljeberg Pasi , Salanterä Sanna , Nelson Ariana M. , Rahmani Amir M.
Published: June 2023

Objective

To develop and evaluate a multimodal machine learning-based objective pain assessment algorithm on data collected from post-operative patients.

Methods

The proposed method addresses the major challenges that come with using data from such patients like the imbalanced distribution of pain classes and the scarcity of ground-truth labels. Specifically, we extracted automatic features using a convolutional autoencoder (AE) along with data augmentation techniques like weak supervision and minority oversampling to improve our models’ predictive performance. This method was used in conjunction with four different machine learning classifiers: Adaptive Boosting (AdaBoost), Random Forest (RF), Support Vector Machine (SVM), and K-Nearest Neighbors (KNN) to perform binary classification on three increasing levels of pain when compared to no pain.

Results

Our models are able to recognize different pain levels with an average balanced accuracy of over 80%.

Conclusion

This is the first multimodal pain recognition work done on postoperative patients and our proposed method provides valuable insights for automatic acute pain recognition in such patients.
Early Experience with Ivabradine for Focal Atrial Tachycardia in Pediatric Patients with Congenital Heart Disease
Authors: Tolani Drishti , Ramdat Misier Nawin L. , Alqahtani Manal , Tindel Kaitlin , Scott William A. , Nguyen Hoang H.
Published: June 2023

Background

Ivabradine is a promising anti-arrhythmic therapy for automatic arrhythmias such as inappropriate sinus tachycardia, junctional ectopic tachycardia, and focal atrial tachycardia (AT). However, experience with ivabradine in pediatric patients, especially those with congenital heart disease (CHD) and focal AT, remains limited. We report our findings using ivabradine for focal AT in infants and children with CHD to assess its efficacy and safety.

Method

A retrospective analysis was conducted on all pediatric patients (<21 years) diagnosed with CHD at Children’s Health of Dallas, who were treated with ivabradine for focal AT. Patient demographics, arrhythmia diagnosis, anti-arrhythmic therapies, and adverse effects were evaluated. A positive response was defined as complete rhythm control within 24 hours of initiation of ivabradine.

Results

Fifteen patients (median age 7 [1-8] months; 9 males (60%)) were included in this study, including 12 (80%) complex CHD. Fourteen patients (93%) had unifocal AT and one (7%) had multifocal AT. The AT occurred in the early post-operative period in six patients (40%). In two patients (13%) ivabradine was used as monotherapy. Positive response to ivabradine was observed in 12 patients (80%). Adverse events occurred in 7 patients (47%) consisting of bradycardic, which was transient, or resolved upon reducing the ivabradine dosage.

Conclusion

In infants and children with CHD, ivabradine was efficacious for the treatment of focal AT without major complications. Bradycardia is a frequent adverse event. Therefore, close monitoring may be required during initiation of therapy.
Instability in longitudinal sleep duration predicts cognitive impairment in aged participants of the Seattle Longitudinal Study
Authors: Keil Samantha A. , Schindler Abigail G. , Wang Marie X. , Piantino Juan , Silbert Lisa C. , Elliott Jonathan E. , Thomas Ronald G. , Willis Sherry , Lim Miranda M. , Iliff Jeffrey J.
Published: June 2023

Importance

Sleep disturbances and clinical sleep disorders are associated with all-cause dementia and neurodegenerative conditions. It remains unclear how longitudinal changes in sleep impact the incidence of cognitive impairment.

Objective

To evaluate how longitudinal sleep patterns contribute to age-related changes in cognitive function in healthy adults.

Design, Setting, Participants

This study utilizes retrospective longitudinal analyses of a community-based study within Seattle, evaluating self-reported sleep (1993-2012) and cognitive performance (1997-2020) in aged adults.

Main Outcomes and Measures

The main outcome is cognitive impairment as defined by sub-threshold performance on 2 of 4 neuropsychological batteries: Mini-Mental State Examination (MMSE), Mattis Dementia Rating Scale, Trail Making Test, and Wechsler Adult Intelligent Scale (Revised). Sleep duration was defined through self-report of ‘average nightly sleep duration over the last week’ and assessed longitudinally. Median sleep duration, change in sleep duration (slope), variability in sleep duration (standard deviation, Sleep Variability), and sleep phenotype (“Short Sleep” median ≤7hrs.; “Medium Sleep” median = 7hrs; “Long Sleep” median ≥7hrs.).

Results

A total of 822 individuals (mean age of 76.2 years [11.8]; 466 women [56.7%]; 216APOEallele positive [26.3%]) were included in the study. Analysis using a Cox Proportional Hazard Regression model (concordance 0.70) showed that increased Sleep Variability (95% CI [1.27,3.86]) was significantly associated with the incidence of cognitive impairment. Further analysis using linear regression prediction analysis (R2=0.201, F (10, 168)=6.010, p=2.67E-07) showed that high Sleep Variability (β=0.3491; p=0.048) was a significant predictor of cognitive impairment over a 10-year period.

Conclusions and Relevance

High variability in longitudinal sleep duration was significantly associated with the incidence of cognitive impairment and predictive of decline in cognitive performance ten years later. These data highlight that instability in longitudinal sleep duration may contribute to age-related cognitive decline.
IE-MOIF: a novel multi-omics early integration framework for biomedical classification and biomarker discovery
Authors: Zhang Wei , Mou Minjie , Hu Wei , Lu Mingkun , Zhang Hongning , Luo Yongchao , Xu Hongquan , Zhang Hanyu , Tao Lin , Dai Haibin , Gao Jianqing , Zhu Feng
Published: June 2023

In the context of precision medicine, multi-omics data integration provides a comprehensive understanding of underlying biological processes and is critical for disease diagnosis and biomarker discovery. One commonly used integration method is early integration through concatenation of multiple dimensionally reduced omics matrices due to its simplicity and ease of implementation. However, this approach is seriously limited by information loss and lack of latent feature interaction. Herein, a novel multi-omics early integration framework (IE-MOIF) based on information enhancement and image representation learning is thus presented to address the challenges. IE-MOIF employs the self-attention mechanism to capture the intrinsic correlations of omics-features, which make it significantly outperform the existing state-of-the-art methods for multi-omics data integration. Moreover, visualizing the attention embedding and identifying potential biomarkers offer interpretable insights into the prediction results. All source codes and model for IE-MOIF are freely availablehttps://github.com/idrblab/IE-MOIF.
Physiology-guided quantitative symptom analysis for gastroduodenal disorders
Authors: Schamberg Gabriel , Varghese Chris , Uren Emma , Calder Stefan , O’Grady Greg , Gharibans Armen A
Published: June 2023

Background

Current approaches to symptom-based classifications in gastroduodenal disorders are binary and substantially overlapping. We aimed to develop a standardized and quantitative system for classifying patient-level symptom profiles guided on physiological principles.

Methods

A large database (n = 787) of 4.5 h (30 min baseline; 4-h postprandial) Gastric Alimetry™ (Alimetry, NZ) recordings were used to identify, and quantify distinct symptom patterns based on established gastroduodenal physiology concepts. Tests comprised a standardized meal challenge and symptoms were simultaneously recorded at minimum 15 minute intervals using a 10-point likert scale with pictograms encoded in a validated digital App.

Key Results

Six symptom profiles were defined. The meal change metric was used to define ‘meal-induced’ and ‘meal-relieved’ symptom profiles, defined as an increase (+2) or decrease (−2) in the average symptom severity between the first post- and pre-prandial hours of recordings. The continuous profile was defined as a reduced range (<3; i.e., difference between the 95th and 5th percentile symptom severity), and thresholded to the 5th percentile of symptom severity being > 2. The symptom/amplitude correlation metric defined the ‘sensorimotor’ profile, thresholded when the correlation was >0.5. The symptom/amplitude time lag metric was used to define ‘activity-relieved’ and ‘post-gastric’ symptom profiles, defined as negative (< -0.25) or positive (>0.25) average difference between the cumulative distribution functions of the symptom and amplitude curves.

Conclusions & Inferences

Standardized quantification of symptom profiles in relation to a meal-stimulus and gastric amplitude offer a novel classification scheme based on gastroduodenal physiology.
In-hospital Outcomes of Septal Myectomy Versus Alcohol Septal Ablation for Hypertrophic Cardiomyopathy with Outflow Tract Obstruction - An Update and Insights from The National Inpatient Sample from 2011-2019
Authors: Inestroza Karla , Mijares-Rojas Ivan , Matute-Martínez Carlos , Ergui Ian , Albosta Michael , Vergara-Sanchez Carlos , Dangl Michael , Hernandez Rafael Jaciel , Ebner Bertrand , Vincent Louis T , Grant Jelani , Maning Jennifer , Alfonso Carlos , Colombo Rosario
Published: June 2023

Background

Septal Myectomy (SM) and Alcohol Septal Ablation (ASA) improve symptoms in patients with Hypertrophic Cardiomyopathy with outflow tract obstruction (oHCM). However, outcomes data in this population is predominantly from specialized centers.

Methods

The National Inpatient Database was queried from 2011- 2019 for relevant ICD-9 and −10 diagnostic and procedural codes. We compared baseline characteristics and in-hospital outcomes of patients with oHCM who underwent SM vs. ASA. A p-value <0.001 was considered statistically significant.

Results

We identified 17,245 patients with oHCM who underwent septal reduction therapies, of whom 62.5% underwent SM, and 37.5% underwent ASA. Patients who underwent SM had higher all-cause mortality (OR:2.2 [1.7-2.9]), post-procedure ischemic stroke (OR: 2.4 [1.8-3.2]), acute kidney injury (OR: 1.9 [1.7-2.2]), vascular complications (OR: 4 [2.8-5.7]), ventricular septal defect (OR: 4.6 [3.5-6.1]), cardiogenic shock (OR: 2 [1.5-2.6]), sepsis (OR: 5.2 [3.3-8.1]), and left bundle branch block (OR: 3.2 [2.8-3.7]), compared to ASA. Patients who underwent ASA had higher post-procedure complete heart block (OR: 1.2 [1.1-1.4]), 2nd-degree AV Block (OR: 2 [1.4-3]), right bundle branch block (OR: 6.4 [5.3-7.8]), ventricular tachycardia (OR:2 [1.8-2.3]), supraventricular tachycardia (OR: 1.4 [1.2-1.7]), and more commonly required pacemaker (OR: 1.4 [1.2-1.6]) or implantable cardioverter-defibrillator insertion (OR: 1.3 [1.1-1.5]) (p<0.001 for all) compared to SM.

Conclusions

This nationwide analysis evidenced that patients undergoing SM had higher in-hospital mortality and periprocedural complications than ASA; however, those undergoing ASA had more post-procedure conduction abnormalities and pacemaker or ICD implantation. The implications of these findings warrant further investigation regarding patient selection strategies for these therapies.