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Experiences of women living with Polycystic Ovary Syndrome: A pilot case-control, single-cycle, daily Menstrual Cycle Diary study during the SARS-CoV-2 pandemic

by Kaitlin Nelson, Sonia Shirin, Dharani Kalidasan, Jerilynn C. Prior

Polycystic Ovary Syndrome (PCOS) affects many people and is often distressing. Much medical literature about diagnosis and treatment exists, but little is known about PCOS menstrual cycle-related experiences except that cycles tend to be far-apart and unpredictable. Our purpose was to examine the menstrual cycle and daily life experiences in those with PCOS having approximately month-apart cycles compared with age and BMI-matched cohort controls using data from the Menstruation & Ovulation Study 2 (MOS2) during the first 1.5 years of SARS-CoV-2 pandemic. We hypothesized that those with PCOS would experience lower self-worth and more negative moods. This is a single-cycle prospective case-control study in community-dwelling women ages 19–35 years. Eight reported physician-diagnosed PCOS and were matched (1:3 ratio) with controls by age (within .6 years) and BMI (within .19 BMI units). Experiences were recorded daily (Menstrual Cycle Diary©, Diary). All kept daily morning temperatures to assess luteal phase lengths by the validated Quantitative Basal Temperature© analysis method. From 112 in MOS2, 32 women were compared: eight with PCOS versus 24 controls. Demographic, socioeconomic, comorbidities and lifestyle variables were not different between the two groups. Cycle lengths were similar in PCOS and controls (one PCOS and control each had oligomenorrhea; most lengths were 21–35 days, P = .593). Unexpectedly, luteal phase lengths were also similar between PCOS and controls (P = .167); anovulation occurred in 5 with PCOS, and in 9 controls. There were no significant Diary differences between the two groups except for greater “outside stress” in the PCOS group (P = .020). In contrast to our hypotheses, there were no significant differences in feelings of self-worth, anxiety nor depression. The SARS-CoV-2 pandemic was a stressful time for women. MOS2 captured granular menstrual cycles, ovulation and daily experiences in women with PCOS compared with age- and BMI-matched controls. These pilot data in women with milder PCOS are the first of more research required to understand the daily experiences in those living with PCOS.

Analysis of maternal and child health spillover effects in PEPFAR countries

Por: Gaumer · G. · Crown · W. H. · Kates · J. · Luan · Y. · Hariharan · D. · Jordan · M. · Hurley · C. L. · Nandakumar · A.
Objectives

This study examined whether the US President’s Emergency Plan for AIDS Relief (PEPFAR) funding had effects beyond HIV, specifically on several measures of maternal and child health in low-income and middle-income countries (LMICs). The results of previous research on the question of PEPFAR health spillovers have been inconsistent. This study, using a large, multicountry panel data set of 157 LMICs including 90 recipient countries, adds to the literature.

Design

Seven indicators including child and maternal mortality, several child vaccination rates and anaemia among childbearing-age women are important population health indicators. Panel data and difference-in-differences estimators (DID) were used to estimate the impact of the PEPFAR programme from inception in 2004 to 2018 using a comparison group of 67 LMICs. Several different models of baseline (2004) covariates were used to help balance the comparison and treatment groups. Staggered DID was used to estimate impacts since all countries did not start receiving aid at PEPFAR’s inception.

Setting

All 157 LMICs from 1990 to 2018.

Participants

90 LMICs receiving PEPFAR aid and cohorts of those countries, including those required to submit annual country operational plans (COP), other recipient countries (non-COP), and three groupings of countries based on cumulative amount of per capita aid received (high, medium, low).

Interventions

PEPFAR aid to combat the HIV epidemic.

Primary outcome measures

Maternal mortality and child mortality rates, vaccination rates to protect children for diphtheria, whooping cough and tetanus, measles, HepB3, and tetanus, and prevalence of anaemia in women of childbearing age.

Results

Across PEPFAR recipient countries, large, favourable PEPFAR health effects were found for rates of childhood immunisation, child mortality and maternal mortality. These beneficial health effects were large and significant in all segments of PEPFAR recipient countries studied. We also found significant and favourable programme effects on the prevalence of anaemia in women of childbearing age in PEPFAR recipient countries receiving the most intensive financial support from the PEPFAR programme. Other recipient countries did not demonstrate significant effects on anaemia.

Conclusions

This study demonstrated that important health indicators, beyond HIV, have been consistently and favourably influenced by PEPFAR presence. Child and maternal mortality have been substantially reduced, and childhood immunisation rates increased. We also found no evidence of ‘crowding out’ or negative spillovers in these resource-poor countries. These findings add to the body of evidence that PEPFAR has had favourable health effects beyond HIV. The implications of these findings are that foreign aid for health in one area may have favourable health effects in other areas in recipient countries. More research is needed on the influence of the mechanisms at work that create these spillover health effects of PEPFAR.

Protection of the third-dose and fourth-dose mRNA vaccines against SARS-CoV-2 Omicron subvariant: a systematic review and meta-analysis

Por: Rahman · M. O. · Kamigaki · T. · Thandar · M. M. · Haruyama · R. · Yan · F. · Shibamura-Fujiogi · M. · Khin Maung Soe · J. · Islam · M. R. · Yoneoka · D. · Miyahara · R. · Ota · E. · Suzuki · M.
Objectives

The rapid spread of the SARS-CoV-2 Omicron variant has raised concerns regarding waning vaccine-induced immunity and durability. We evaluated protection of the third-dose and fourth-dose mRNA vaccines against SARS-CoV-2 Omicron subvariant and its sublineages.

Design

Systematic review and meta-analysis.

Data sources

Electronic databases and other resources (PubMed, Embase, CENTRAL, MEDLINE, CINAHL PLUS, APA PsycINFO, Web of Science, Scopus, ScienceDirect, MedRxiv and bioRxiv) were searched until December 2022.

Study eligibility criteria

We included studies that assessed the effectiveness of mRNA vaccine booster doses against SARS-CoV-2 infection and severe COVID-19 outcomes caused by the subvariant.

Data extraction and synthesis

Estimates of vaccine effectiveness (VE) at different time points after the third-dose and fourth-dose vaccination were extracted. Random-effects meta-analysis was used to compare VE of the third dose versus the primary series, no vaccination and the fourth dose at different time points. The certainty of the evidence was assessed by Grading of Recommendations, Assessments, Development and Evaluation approach.

Results

This review included 50 studies. The third-dose VE, compared with the primary series, against SARS-CoV-2 infection was 48.86% (95% CI 44.90% to 52.82%, low certainty) at ≥14 days, and gradually decreased to 38.01% (95% CI 13.90% to 62.13%, very low certainty) at ≥90 days after the third-dose vaccination. The fourth-dose VE peaked at 14–30 days (56.70% (95% CI 50.36% to 63.04%), moderate certainty), then quickly declined at 61–90 days (22% (95% CI 6.40% to 37.60%), low certainty). Compared with no vaccination, the third-dose VE was 75.84% (95% CI 40.56% to 111.12%, low certainty) against BA.1 infection, and 70.41% (95% CI 49.94% to 90.88%, low certainty) against BA.2 infection at ≥7 days after the third-dose vaccination. The third-dose VE against hospitalisation remained stable over time and maintained 79.30% (95% CI 58.65% to 99.94%, moderate certainty) at 91–120 days. The fourth-dose VE up to 60 days was 67.54% (95% CI 59.76% to 75.33%, moderate certainty) for hospitalisation and 77.88% (95% CI 72.55% to 83.21%, moderate certainty) for death.

Conclusion

The boosters provided substantial protection against severe COVID-19 outcomes for at least 6 months, although the duration of protection remains uncertain, suggesting the need for a booster dose within 6 months of the third-dose or fourth-dose vaccination. However, the certainty of evidence in our VE estimates varied from very low to moderate, indicating significant heterogeneity among studies that should be considered when interpreting the findings for public health policies.

PROSPERO registration number

CRD42023376698.

Persistence of gut dysbiosis in individuals with anorexia nervosa

by Yukiko Morisaki, Noriyuki Miyata, Megumi Nakashima, Tomokazu Hata, Shu Takakura, Kazufumi Yoshihara, Takafumi Suematsu, Koji Nomoto, Kouji Miyazaki, Hirokazu Tsuji, Nobuyuki Sudo

Recent evidence suggests a crucial role of the gut microbiota in the pathogenesis of anorexia nervosa (AN). In this study, we carried out a series of multiple analyses of the gut microbiota of hospitalized individuals with AN over three months using 16S or 23S rRNA-targeted reverse transcription–quantitative polymerase chain reaction (PCR) technology (YIF-SCAN®), which is highly sensitive and enables the precise quantification of viable microorganisms. Despite the weight gain and improvements in psychological features observed during treatment, individuals with AN exhibited persistent gut microbial dysbiosis over the three-month duration. Principal component analysis further underscored the distinct microbial profile of individuals with AN, compared with that of age-matched healthy women at all time points. Regarding the kinetics of bacterial detection, the detection rate of Lactiplantibacillus spp. significantly increased after inpatient treatment. Additionally, the elevation in the Bifidobacterium counts during inpatient treatment was significantly correlated with the subsequent body weight gain after one year. Collectively, these findings suggest that gut dysbiosis in individuals with AN may not be easily restored solely through weight gain, highlighting the potential of therapeutic interventions targeting microbiota via dietary modifications or live biotherapeutics.

Predictors of changes in resilience among spousal caregivers of patients with advanced cancer within the first 6 months after initial treatment

Abstract

Background

While previous research has established that resilience is affected by various factors, these studies have primarily focussed on individual variables associated with resilience, without providing insights into how to influence the rate of change in resilience.

Aim

To examine the trajectory of resilience and identify the factors associated with changes in resilience among spousal caregivers of patients with newly diagnosed advanced cancer receiving treatment during the first 6 months.

Design

An observational longitudinal study.

Methods

A total of 312 spousal caregivers of patients with newly diagnosed advanced cancer were recruited from January 2022 to December 2022 in Yancheng, China. Three data collection points were established, spanning from the first month to 6 months after initial cancer treatment. A latent growth model was employed to depict the resilience trajectory at various time points. A latent growth model with time-invariant covariates was adopted to determine the factors influencing resilience trajectory. The study adhered to the STROBE checklist for proper reporting.

Results

Throughout the follow-up period, the participants experienced a significant increase in resilience. Gender, family income, the patient's health status, spirituality and belief in familism were significantly associated with the baseline resilience level. Moreover, family income, the patient's health status, spirituality, caregiver burden and belief in familism were significantly associated with the rate of resilience change over time.

Conclusions

Spousal caregivers demonstrated a linear increase in resilience during the first 6 months after initial treatment. Meanwhile, changes in resilience were influenced by multiple factors during the early phase of cancer treatment. Thus, more attention should be paid to early identification and implementation of targeted interventions.

Relevance to Clinical Practice

Healthcare professionals should understand the change in resilience among spousal caregivers and conduct timely mental health interventions to enhance the resilience of families affected by cancer.

Patient or Public Contribution

The Guidance for Reporting Involvement of Patients and the Public-Short Form reporting checklists were used to improve patient and public involvement.

Comparative analysis of silver-nanoparticles and whey-encapsulated particles from olive leaf water extracts: Characteristics and biological activity

by Hanem M. M. Mansour, Mohamed G. Shehata, Eman M. Abdo, Mona Mohamad Sharaf, El-sayed E. Hafez, Amira M. Galal Darwish

Nanotechnology applications have been employed to improve the stability of bioactive components and drug delivery. Natural-based extracts, especially olive leaf extracts, have been associated with the green economy not only as recycled agri-waste but also in the prevention and treatment of various non-communicable diseases (NCDs). The aim of this work was to provide a comparison between the characteristics, biological activity, and gene expression of water extract of olive leaves (OLE), green synthesized OLE silver nanoparticles (OL/Ag-NPs), and OLE whey protein capsules (OL/WPNs) of the two olive varieties, Tofahy and Shemlali. The particles were characterized by dynamic light scattering, scanning electron microscope (SEM), and Fourier transform infrared. The bioactive compounds of the preparations were evaluated for their antioxidant activity and anticancer effect on HCT-116 colorectal cells as well as for their regulatory effects on cytochrome C oxidase (Cox1) and tumor necrosis factor α (TNF-α) genes. (OL/Ag-NPs) were found to be smaller than (OL/WPNs) with sizes of (37.46±1.85 and 44.86±1.62 nm) and (227.20±2.43 and 553.02±3.60 nm) for Tofahy and Shemlali, respectively. SEM showed that Shemlali (OL/Ag-NPs) had the least aggregation due to their highest Ƹ-potential (-31.76 ± 0.87 mV). The preparations were relatively nontoxic to Vero cells (IC50 = 151.94–789.25 μg/mL), while they were cytotoxic to HCT-116 colorectal cells (IC50 = 77.54–320.64 μg/mL). Shemlali and Tofahy OLE and Tofahy OL/Ag-NPs had a higher selectivity index (2.97–7.08 μg/mL) than doxorubicin (2.36 μg/mL), indicating promising anticancer activity. Moreover, Shemlali preparations regulated the expression of Cox1 (up-regulation) and TNF-α (down-regulation) on HCT-116 cells, revealing their efficiency in suppressing the expression of genes that promote cancer cell proliferation. (OL/Ag-NPs) from Tofahy and Shemlali were found to be more stable, effective, and safe than (OL/WPNs). Consequently, OL/Ag-NPs, especially Tofahy, are the best and safest nanoscale particles that can be safely used in food and pharmaceutical applications.

Effectiveness of transcranial direct current stimulation (tDCS) as adjunctive treatment for chronic headache in adults with clinically stable systemic lupus erythematosus (SHADE): a randomised double-blind multiarm sham controlled clinical trial

Por: Estiasari · R. · Tiksnadi · A. · Tunjungsari · D. · Maharani · K. · Aninditha · T. · Sofyan · H. R. · Savitri · I. · Pangeran · D. · Jeremia · I. · Widhani · A. · Ariane · A.
Background

Chronic headache is a ‘silent’ neuropsychiatric systemic lupus erythematosus symptom with heterogeneous prevalence, potentially reaching 54.4%. It may reduce quality of life by increasing the likelihood of depression and sleep disturbance. While pharmacotherapy remains the first-line treatment, the current management is still challenging and needs other non-invasive modalities. An effective, tolerable and disease-specific treatment modality including transcranial direct current stimulation (tDCS) is considered to reduce the frequency of chronic headaches, including in SLE. Until recently, there was no standard protocol for tDCS in treating headaches.

Methods and analysis

SHADE is a single-centre randomised double-blind multiarm sham-controlled trial for adults with clinically stable SLE, chronic headaches and without history of traumatic brain injury, brain infection, stroke or brain tumour. Random allocation is conducted to 88 subjects into 3 treatment groups (administration at primary motor, primary sensory and dorsolateral prefrontal cortex) and control group in 1:1:1:1 ratio. The primary endpoint is reduced number of headache days after adjunctive tDCS. The secondary endpoints are reduced headache intensity, increased quality of life, increased sleep quality, decreased depression and reduced analgesics use. The outcome is measured monthly until 3-month postintervention using headache diary, 36-Item Short Form Survey, Chronic Headache Quality of Life Questionnaire, Pittsburgh Sleep Quality Index and Mini International Neuropsychiatry Interview version 10 (MINI ICD 10). Intention-to-treat analysis will be performed to determine the best tDCS electrode placement.

Ethics and dissemination

Ethical approval had been obtained from the local Institutional Review Board of Faculty of Medicine Universitas Indonesia. Results will be published through scientific relevant peer-reviewed journals.

Trial registration number

NCT05613582.

Impact of treatment of hyperkalaemia on quality of life: design of a prospective observational cohort study of long-term management of hyperkalaemia in patients with chronic kidney disease or chronic heart failure in Japan

Por: Shibagaki · Y. · Yamazaki · H. · Wakita · T. · Ware · J. E. · Wang · J. · Onishi · Y. · Yajima · T. · Sada · K.-E. · Yamamoto · Y. · Fukuhara · S.
Introduction

Hyperkalaemia (HK) is a frequent complication in patients with chronic kidney disease (CKD) and/or chronic heart failure (CHF). HK must be managed, both to protect patients from its direct clinical adverse outcomes and to enable treatment with disease-modifying therapies including renin–angiotensin–aldosterone system inhibitors. However, the experiences of patients undergoing treatment of HK are not clearly understood. Optimising treatment decisions and improving long-term patient management requires a better understanding of patients’ quality of life (QOL). Thus, the aims of this research are: (1) to describe treatment patterns and the impact of treatment on a patient’s QOL, (2) to study the relationships between treatment patterns and the impact of treatment on a patient’s QOL and (3) to study the relationships between the control of serum potassium (S-K) and the impact of treatment on a patient’s QOL, in patients with HK.

Methods and analysis

This is a prospective cohort study with 6 months of follow-up in 30–40 outpatient nephrology and cardiology clinics in Japan. The participants will be 350 patients with CKD or CHF who received their first potassium binders (PB) prescription to treat HK within the previous 6 months. Medical records will be used to obtain information on S-K, on treatment of HK with PBs and with diet, and on the patients’ characteristics. To assess the impact of treatment on a patient’s QOL, questionnaires will be used to obtain generic health-related QOL, CKD-specific and CHF-specific QOL, and PB-specific QOL. Multivariable regression models will be used to quantify how treatment patterns and S-K control are related to the impact of treatment on a patient’s QOL.

Ethics and dissemination

Institutional review boards at all participating facilities review the study protocol. Patient consent will be obtained. The results will be published in international journals.

Trial registration number

NCT05297409.

Towards a pan marsupial sero-immunological tool in the demanding field of wildlife serology: Marsupial immunoglobulin-binding capability with protein A/G, protein L and anti-kangaroo antibody

by K. L. D. Tharaka D. Liyanage, Paola K. Vaz, Abdul Jabbar, Jasmin Hufschmid

Detection of infections in wildlife species is increasingly important to reduce the risk of spreading zoonotic and economically important parasites, understand disease epidemiology and promote the conservation of wildlife species. Serological tests are key in disease diagnosis and surveillance by detecting immunoglobulins against infectious agents. However, the need for species-specific reagents has limited the application of serological tests in wildlife species. This study evaluated the serum immunoglobulin-binding capability of polyclonal anti-kangaroo antibody and two non-species-specific reagents, including protein A/G and protein L, with the largest range of Australian marsupial species so far, including 32 species representing three major marsupial orders. Immunoglobulin-binding capability was assessed using immunoblotting, enzyme-linked immunosorbent assay and Western blot techniques. Variation in immunoglobulin-binding capability was observed between the three reagents and across the species tested, both across but also within taxonomic groups. Taxonomic distance was thus not always a good predictor of immunoglobulin-binding affinity, emphasizing the need to validate these reagents for each species separately. However, all three reagents bound with the serum immunoglobulins of most marsupial species tested. The findings of this study provide a valuable reference for species differences in affinity to protein A/G, protein L and anti-kangaroo antibody, assisting in the selection of appropriate reagents and the development of sero-immunological assays in Australian marsupials.

Cultura kosher y judía estadounidense en “Indignación” de Philip Roth

Objective: Abstract: “Kosher” is a word used to illustrate the food laws of Jewish people. It’s a traditional Jewish law for food. For Jews, it’s more than food
consumption with safety. It’s regarding religious beliefs and traditions. Jews follow proper guidelines of Kosher and give the compulsion to food to be reckoned Kosher.
The English word “Kosher” is derived from the Hebrew root “Kasher”, which means to be pure, proper, or suitable for consumption. Kashrut is a charter that renders the foundation for kosher dietetic rule and is established inside ‘Torah’ which is a Jewish sacred book. Kosher dietetic rules are including all and produce a strict structure of rules and regulations which gives a sketch of foods allowed or prohibited. It also determines how foods allowed should be made, refined, and fixed before eating. The paper illustrates kosher law and food among American-Jewish people and their determination
towards their religious beliefs in American land, which is not their motherland, with analysis from Philip Roth’s novel Indignation. This paper also ascertains
Jewish culture into the outlook of American culture which ends with a cultural clash referring to historical consequences.

Study protocol for a prospective, multicentre, phase II trial on endoscopic treatment using two fully covered self-expandable metallic stents for benign strictures after hepaticojejunostomy

Por: Kawasaki · Y. · Hijioka · S. · Nagashio · Y. · Ohba · A. · Maruki · Y. · Takeshita · K. · Takasaki · T. · Yagi · S. · Agarie · D. · Hagiwara · Y. · Hara · H. · Okamoto · K. · Yamashige · D. · Fukuda · S. · Kuwada · M. · Kondo · S. · Morizane · C. · Ueno · H. · Okusaka · T.
Introduction

The current endoscopic treatment for postoperative benign hepaticojejunostomy anastomotic stricture (HJAS) has a high technical success rate and is highly effective in the short term. However, long-term results have shown a high rate of stenosis recurrence, which indicates an insufficient response to treatment. Three prospective studies on fully covered self-expandable metallic stent (FC-SEMS) treatment for benign HJAS used the stenosis resolution rate as the primary endpoint, and no study has yet used the long-term non-stenosis rate (at 12 months) as the primary endpoint.

Methods and analysis

We launched the ‘saddle-cross study’, which will be conducted as a multicentre, prospective intervention of endoscopic treatment using two modified FC-SEMSs (BONASTENT M-Intraductal) that have been improved for benign stenosis in patients with benign HJAS, with the long-term non-restenosis rate (at 12 months) as the primary endpoint. This study aims to evaluate the long-term non-restenosis rate (at 12 months) and safety of the saddle-cross technique for benign HJAS. We plan to enrol 50 participants.

Ethics and dissemination

This study has been approved by the Certified Review Board of the National Cancer Center, Japan (CRB3180009). The results will be reported at various conferences and published in international peer-reviewed journals.

Detrimental impact of sulfide on the seagrass <i>Zostera marina</i> in dark hypoxia

by Harald Hasler-Sheetal

Sulfide poisoning, hypoxia events, and reduced light availability pose threats to marine ecosystems such as seagrass meadows. These threats are projected to intensify globally, largely due to accelerating eutrophication of estuaries and coastal environments. Despite the urgency, our current comprehension of the metabolic pathways that underlie the deleterious effects of sulfide toxicity and hypoxia on seagrasses remains inadequate. To address this knowledge gap, I conducted metabolomic analyses to investigate the impact of sulfide poisoning under dark-hypoxia in vitro conditions on Zostera marina, a vital habitat-forming marine plant. During the initial 45 minutes of dark-hypoxia exposure, I detected an acclimation phase characterized by the activation of anaerobic metabolic pathways and specific biochemical routes that mitigated hypoxia and sulfide toxicity. These pathways served to offset energy imbalances, cytosolic acidosis, and sulfide toxicity. Notably, one such route facilitated the transformation of toxic sulfide into non-toxic organic sulfur compounds, including cysteine and glutathione. However, this sulfide tolerance mechanism exhibited exhaustion post the initial 45-minute acclimation phase. Consequently, after 60 minutes of continuous sulfide exposure, the sulfide toxicity began to inhibit the hypoxia-mitigating pathways, culminating in leaf senescence and tissue degradation. Utilizing metabolomic approaches, I elucidated the intricate metabolic responses of seagrasses to sulfide toxicity under in vitro dark-hypoxic conditions. My findings suggest that future increases in coastal eutrophication will compromise the resilience of seagrass ecosystems to hypoxia, primarily due to the exacerbating influence of sulfide.

Association between lignan polyphenol bioavailability and enterotypes of isoflavone metabolism: A cross-sectional analysis

by Tomoko Fujitani, Mariko Harada Sassa, Zhaoqing Lyu, Yukiko Fujii, Kouji H. Harada

Lignan polyphenols derived from plants are metabolized by bacteria in the gut to mammalian lignans, such as enterolactone (ENL) and enterodiol (END). Mammalian lignan intake has been reported to be associated with obesity and low blood glucose levels. However, the factors that are responsible for individual differences in the metabolic capacity for ENL and END are not well understood. In the present study, the effects of enterotypes of isoflavone metabolism, equol producers (EQP) and O-desmethylangolensin producers (O-DMAP), on lignan metabolism were examined. EQP was defined by urinary daidzein (DAI) and equol concentrations as log(equol/DAI) ≥ –1.42. O-DMAP was defined by urinary DAI and O-DMA concentrations as O-DMA/DAI > 0.018. Isoflavone and lignan concentrations in urine samples from 440 Japanese women were measured by gas chromatography-mass spectrometry. Metabolic enterotypes were determined from the urinary equol and O-DMA concentrations. Urinary END and ENL concentrations were compared in four groups, combinations of EQP (+/–) and O-DMAP (+/–). The urinary lignan concentration was significantly higher in the O-DMAP/EQP group (ENL: P

Public perceptions of physician-pharmaceutical industry relationships and trust in physicians

by Sayaka Saito, Kei Mukohara, Kazuhiro Shimomura, Kenta Murotani

Background

In Japan, as elsewhere, physicians meet with and receive gifts from pharmaceutical representatives (PRs). This study aimed to clarify the Japanese public perceptions of physicians’ relationships with PRs, examine the association between these perceptions and their trust in physicians, and compare the public’s and physicians’ awareness, acceptance, and perceptions of the influence of physician-PR relationships.

Methods

A cross-sectional, self-administered, anonymous, internet-panel survey was conducted involving 1,000 participants from the general public. The survey implementation was contracted to Cross Marketing Inc.

Results

The mean age of the 1000 participants was 44.8 years (standard deviation 18.3). Forty-eight percent were female. Many of our participants were unaware of certain physician-PR relationships. The public was more acceptable with physicians’ receiving stationery and/or medical textbooks and attending promotional drug seminars at their workplaces compared with receiving meals at restaurants. Many thought that physicians’ involvement in promotional activities influenced their prescribing habits and estimated that the majority of physicians received office stationery and meals from PRs. They were divided as to whether they would like to know about their physicians’ relationships with the industry. Factors associated with higher trust in physicians included participants being 65 years or older, having a primary care physician, being in better health, the belief that physicians’ involvement in promotional activities is acceptable, and their high estimate that physicians are not receiving gifts from PRs. Compared to the physicians, the public had lower awareness of and was more accepting of physicians’ involvement in promotional activities. Meanwhile, the public believed that physician-PR relationships influenced physicians’ prescribing habits more than the physicians themselves.

Conclusion

Our survey provided insights into Japanese public perceptions of physician-pharmaceutical industry relationships and their impact on trust in physicians. Physicians should be aware of these perceptions and carefully consider how to foster appropriate relationships with the industry.

Antibiofilm and antimicrobial activity of Lactobacillus cell free supernatant against Pseudomonas aeruginosa isolated from burn wounds

Abstract

The present study investigated the antimicrobial and anti-biofilm effects of indigenous Lactobacillus probiotic strains on Pseudomonas aeruginosa isolated from burn wound infection in laboratory conditions. The effect of 7 probiotic strains isolated from infant faeces on the pathogenicity factors of P. aeruginosa, including protease, elastase, antibiofilm and antipyocyanin was measured. Also, diffusion methods in the well and micro broth dilution were used to evaluate the antimicrobial activity of probiotics. All tests were performed in triplicate. A negative control and a positive control were used for each test. SPSS version 22 software was used for statistical analysis, and a p < 0.05 was considered statistically significant. A total of 30 clinical isolates of P. aeruginosa were isolated. The elastolytic activity of P. aeruginosa isolates decreased after adding Cell free supernatant (CFS) of each Lactobacillus. L1, L4, L5, and L6 strains had a 100% inhibitory effect on pathogen isolates. L3 and L7 strains had the lowest inhibitory effect. The inhibitory effect of CFS extracted from lactobacilli on protease production by P. aeruginosa. L1, L4, L5, and L6 strains had an inhibitory effect on all tested isolates. L2, L3, and L7 strains had a less inhibitory effect. L4 strain had the highest inhibitory effect on pyocyanin production by P. aeruginosa (50%), followed by L5 (43.3%), L1 (40%), and L6 (23.3%) strains. L3 and L7 strains had no inhibitory effect on the pyocyanin production of P. aeruginosa isolates. It was found that the CFS of 4 isolates (L1, L4, L5, and L6) was the most active extract and had a 100% inhibitory effect against biofilm formation of all P. aeruginosa strains. The L3 strain had the least inhibitory effect against the biofilm formation of pathogens. Overall, this study showed that probiotics could be promising alternatives to combat the pathogenicity of P. aeruginosa in burn wounds.

Adherence to limiting weight‐bearing activity in patients with diabetic foot ulcers: A qualitative study

Abstract

Patients with diabetic foot ulcers are advised to limit weight-bearing activity for ulcers to heal. Patients often disregard this advice although the reasons are not yet fully understood. This study explored (1) patients' experiences of receiving the advice and (2) factors influencing adherence to the advice. Semi-structured interviews were conducted with 14 patients with diabetic foot ulcers. Interviews were transcribed and analysed using inductive thematic analysis. Advice regarding limiting weight-bearing activity was described by patients as directive, generic and conflicting with other priorities. Rapport, empathy and rationale supported receptivity to the advice. Barriers and facilitators to limiting weight-bearing activity included demands of daily living, enjoyment of exercise, sick/disabled identity and burden, depression, neuropathy/pain, health benefits, fear of negative consequences, positive feedback, practical support, weather and active/passive role in recovery. It is important that healthcare professionals pay attention to how limiting weight-bearing activity advice is communicated. We propose a more person-centred approach in which advice is tailored to individuals' specific needs with discussion around patient priorities and constraints.

Self-reported and parent-reported mental health in children from low-income families in Agder, Norway: results from baseline measurements of New Patterns project participants

Por: Boe · T. · Ostojic · H. A. · Haraldstad · K. · Abildsnes · E. · Wilson · P. · Vigsnes · K. · Molland · E.
Background

Poverty may pose risks to child and adolescent mental health, but few studies have reported on this association among children and adolescents in low-income families in Norway.

Methods

Based on a sample participating in an intervention for low-income families in Norway, we report data from the survey administered at the start of the intervention. Mental health problems were measured using the Strengths and Difficulties Questionnaire (SDQ; self-report (SR) n = 148; parent/proxy-report (PR) n = 153, mean age = 10.8). Demographic and family characteristics were obtained from parent reported data. Results are presented by gender and migration background. Regression analysis was used to investigate the relative contribution of background factors to mental health symptoms. The distribution of scores is compared to UK norms.

Results

Participants reported relatively high scores on the Strengths and Difficulties Questionnaire (SDQ) Total Difficulties Scale (parent/proxy-report, PR mean=10.7; self-report, SR mean=10.1). Participants with non-immigrant backgrounds scored considerably higher on the Total Difficulties Scale (PR mean difference=2.9; SR 5.3) and on most other domains measured with the SDQ compared with their peers with immigration backgrounds. Participants generally scored higher than or equal to UK norms.

Conclusion

Participants in the current study had many symptoms of mental health problems, with large differences between those with and without a migrant background. Interventions for low-income families should be based on detailed knowledge about differences in family risks, resources and needs.

Frailty and social isolation before and during the coronavirus disease 2019 pandemic among older adults: A path analysis

Abstract

Aim

To explore the prevalence of social isolation among Japanese community-dwelling older adults before and during the COVID-19 pandemic as well as determine how family and friend connections before and during the pandemic affected frail older adults during the pandemic.

Design

A cross-sectional study.

Methods

A total of 852 community-dwelling older adults in Hokkaido and Tokyo, Japan were surveyed conducted between April and November 2021 using convenience sampling. The Lubben social network scale-6, frailty screening index, and geriatric depression scale were used to assess social isolation, frailty and depression, respectively. A path analysis was conducted to evaluate the effect of social isolation on frailty.

Results

Participants had a mean age of 76.8 ± 6.6 years. Overall, 46% and 59% of participants were socially isolated before and during the COVID-19 pandemic, respectively. Frailty was found in 19% of participants during the pandemic. Friends and family connectedness before the pandemic had no direct relationship with frailty; only friend connectedness affected frailty indirectly via depression. Family connectedness during the pandemic had a significant, negative and direct relationship with frailty.

Conclusion

The findings show that connectedness with family and friends is critical for older people's physical and mental health.

Impact

Nurses in the community should consider these findings to reduce mental health problems and physical decline among older adults. It is important to identify older adults who are socially isolated from their families or friends and provide resources to help them build relationships within their communities.

Patient or Public Contribution

Community centre staff and community volunteers assisted in data collection. The public was not involved in data analysis, interpretation or manuscript preparation.

Registry study of immune-related adverse events using electronic patient-reported outcome in patients with cancer receiving immune checkpoint inhibitors: protocol for a multicentre cohort study

Por: Hirata · T. · Kawaguchi · T. · Azuma · K. · Torii · A. · Usui · H. · Kim · S. · Hayama · T. · Hirate · D. · Kawahara · Y. · Kumihashi · Y. · Chisaka · T. · Wako · T. · Yoshimura · A. · Miyaji · T. · Yamaguchi · T.
Introduction

The use of immune checkpoint inhibitors (ICIs) is rapidly expanding in cancer treatment. ICIs have a unique safety profile, characterised by immune-related adverse events (irAEs). The safety profile of ICIs lacks patient experience and perspectives. This study primarily aims to obtain a database for descriptive research on the status of irAEs using the Patient-Reported Outcomes version of the Common Terminology Criteria (PRO-CTCAE) in patients with gastrointestinal cancer, lung cancer and malignant pleural mesothelioma treated with regimens containing ICIs.

Methods and analysis

This is an ongoing, multicentre, observational study in Japan. Eligible patients must be at least 20 years old and have been diagnosed with lung cancer, malignant pleural mesothelioma or gastrointestinal cancer and plan to use ICIs. Participants will install the electronic PRO (ePRO) application and report adverse events via ePRO using PRO-CTCAE once weekly for up to 48 weeks. A registry will be established using background information obtained from medical records. The sample size is determined by 1 year projection without using statistical methods. Statistical analyses will include point estimates and 95% CIs for the incidence of each adverse event by cancer type and regimen at each time point.

Ethics and dissemination

This research will be conducted per the Declaration of Helsinki, the Ethical Guidelines for Life Science and Medical Research Involving Human Subjects issued by the Ministry of Education, Culture, Sports, Science and Technology and the Ministry of Health, Labor and Welfare, and the revised Personal Information Protection Law. The study protocol was approved by the Ethics Committee (approval ID T2021-0180) of Tokyo Medical University Hospital on 15 October 2021.

Registration details

The study began enrolling patients in December 2021. The target enrolment is 260; as of October 2022, 141 have been enrolled, and the enrolment is scheduled to end on 30 June 2023.

Trial registration number

UMIN000046418

Regional variation in the use of revascularisation for peripheral artery disease in Japan: a cross-sectional observational study

Por: Kanda · M. · Kuwabara · H. · Kitahara · H. · Kobayashi · Y. · Inoue · T.
Objectives

We aimed to investigate the regional variations in the number of interventions and surgeries for peripheral artery disease (PAD) and explore the major determinants of the variations.

Design

Cross-sectional study.

Setting

The Japanese Ministry of Health, Labour and Welfare National Database and Diagnostic Procedure Combination database in 2018.

Data

The rates of endovascular treatment (EVT), bypass surgery per 100 000 individuals in the population were calculated for all 47 prefectures in Japan. The total annual changes in the rates of EVT and bypass surgery in Japan from 2012 to 2019 were calculated.

Analysis

A linear regression model was developed with rates of EVT and bypass surgery as dependent variables and regional medical supply in each prefecture as explanatory variables. These regional factors included the rate of percutaneous coronary intervention (PCI) for angina, the numbers of cardiovascular specialists, specialists in cardiac surgery, interventional radiology (IVR) training facilities and cardiovascular surgery training facilities, per 100 000, respectively.

Results

There was a 5.7-fold difference (143 and 25 per 100 000 individuals aged ≥40 years) in the highest and lowest EVT rates. The highest and lowest rates of bypass surgery were 34 and

Conclusions

Considerable regional variations in the rates of revascularisation for PAD were found. Unbalanced presence of medical resources, preference of suppliers and the training system had larger effects on the regional variation in Japan.

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