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☐ ☆ ✇ PLOS ONE Medicine&Health

Feasibility and metabolic outcomes of a well-formulated ketogenic diet as an adjuvant therapeutic intervention for women with stage IV metastatic breast cancer: The Keto-CARE trial

by Alex Buga, David G. Harper, Teryn N. Sapper, Parker N. Hyde, Brandon Fell, Ryan Dickerson, Justen T. Stoner, Madison L. Kackley, Christopher D. Crabtree, Drew D. Decker, Bradley T. Robinson, Gerald Krystal, Katherine Binzel, Maryam B. Lustberg, Jeff S. Volek

Purpose

Ketogenic diets may positively influence cancer through pleiotropic mechanisms, but only a few small and short-term studies have addressed feasibility and efficacy in cancer patients. The primary goals of this study were to evaluate the feasibility and the sustained metabolic effects of a personalized well-formulated ketogenic diet (WFKD) designed to achieve consistent blood beta-hydroxybutyrate (βHB) >0.5 mM in women diagnosed with stage IV metastatic breast cancer (MBC) undergoing chemotherapy.

Methods

Women (n = 20) were enrolled in a six month, two-phase, single-arm WFKD intervention (NCT03535701). Phase I was a highly-supervised, ad libitum, personalized WFKD, where women were provided with ketogenic-appropriate food daily for three months. Phase II transitioned women to a self-administered WFKD with ongoing coaching for an additional three months. Fasting capillary βHB and glucose were collected daily; weight, body composition, plasma insulin, and insulin resistance were collected at baseline, three and six months.

Results

Capillary βHB indicated women achieved nutritional ketosis (Phase I mean: 0.8 mM (n = 15); Phase II mean: 0.7 mM (n = 9)). Body weight decreased 10% after three months, primarily from body fat. Fasting plasma glucose, plasma insulin, and insulin resistance also decreased significantly after three months (p Conclusions

Women diagnosed with MBC undergoing chemotherapy can safely achieve and maintain nutritional ketosis, while improving body composition and insulin resistance, out to six months.

☐ ☆ ✇ BMJ Open

Longitudinal symptom profile of palliative care patients receiving a nurse-led end-of-life (PEACH) programme to support preference to die at home

Por: Agar · M. · Xuan · W. · Lee · J. · Barclay · G. · Oloffs · A. · Jobburn · K. · Harlum · J. · Maurya · N. · Chow · J. S. F. — Enero 2nd 2024 at 16:31
Objectives

Tailored models of home-based palliative care aimed to support death at home, should also ensure optimal symptom control. This study aimed to explore symptom occurrence and distress over time in Palliative Extended And Care at Home (PEACH) model of care recipients.

Design

This was a prospective cohort study.

Setting and participants

Participants were consecutive recipients of the PEACH rapid response nurse-led model of care in metropolitan Sydney (December 2013–January 2017) who were in the last weeks of life with a terminal or deteriorating phase of illness and had a preference to be cared or die at home.

Outcome measures

Deidentified data including sociodemographic and clinical characteristics, and symptom distress scores (Symptom Assessment Score) were collected at each clinical visit. Descriptive statistics and forward selection logistic regression analysis were used to explore influence of symptom distress levels on mode of separation ((1) died at home while still receiving a PEACH package, (2) admitted to a hospital or an inpatient palliative care unit or (3) discharged from the package (alive and no longer requiring PEACH)) across four symptom distress level categories.

Results

1754 consecutive clients received a PEACH package (mean age 70 years, 55% male). 75.7% (n=1327) had a home death, 13.5% (n=237) were admitted and 10.8% (n=190) were still alive and residing at home when the package ceased. Mean symptom distress scores improved from baseline to final scores in the three groups (p

Conclusion

Tailored home-based palliative care models to meet preference to die at home, achieve this while maintaining symptom control. A focus on particular symptoms may further optimise these models of care.

☐ ☆ ✇ BMJ Open

Individual and community-level risk factors for maternal morbidity and mortality among Native American women in the USA: protocol for systematic review

Por: Celaya · M. F. · Madhivanan · P. · McClelland · J. · Zahlan · A. · Rock · C. · Nathan · A. · Acharya · A. — Diciembre 30th 2023 at 13:21
Introduction

Incidents of maternal morbidity and mortality (MMM) continue to rise in the USA. Significant racial and ethnic health inequities exist, with Native American (NA) women being three to four times more likely to die than white, non-Hispanic women, and three to five times more likely to experience an incident of severe maternal morbidity. Few studies have identified individual and community-level risk factors of MMM experienced by NA women. Therefore, this systematic review will identify said risk factors of MMM experienced by NA women in the USA.

Methods and analysis

This systematic review will be conducted according to the Cochrane Handbook for Systematic Reviews, and the findings will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines (PRISMA). The search strategy will include searches from electronic databases: PUBMED, EMBASE, CINAHL and SCOPUS, from 1 January 2012 to 10 October 2022. The search strategy will include terms related to the search concepts: ‘maternal’, ‘Native American’ and ‘MMM’. Bibliographies of selected articles, previously published reviews and high-yield journals will also be searched. All included papers will be evaluated for quality and bias using NIH Quality Assessment Tools for Observational Studies. A description of the study findings will be presented in a tabular format organised by outcome of interest along with study characteristics.

Ethics and dissemination

There are no formal ethics approvals needed for this protocol. The findings of this systematic review will be shared with academic, governmental, community-based, institutes and NA (tribal) entities via a published peer-reviewed article, informational brief, poster and oral presentations.

PROSPERO registration number

CRD42022363405.

☐ ☆ ✇ PLOS ONE Medicine&Health

Multiocular defect in the Old English Sheepdog: A canine form of Stickler syndrome type II associated with a missense variant in the collagen-type gene <i>COL11A1</i>

by Katherine Stanbury, Renata Stavinohova, Louise Pettitt, Chris Dixon, Ellen C. Schofield, Bryan Mclaughlin, Inka Pettinen, Hannes Lohi, Sally L. Ricketts, James A. Oliver, Cathryn S. Mellersh

Multiocular defect has been described in different canine breeds, including the Old English Sheepdog. Affected dogs typically present with multiple and various ocular abnormalities. We carried out whole genome sequencing on an Old English Sheepdog that had been diagnosed with hereditary cataracts at the age of five and then referred to a board-certified veterinary ophthalmologist due to owner-reported visual deterioration. An ophthalmic assessment revealed that there was bilateral vitreal degeneration, macrophthalmos, and spherophakia in addition to cataracts. Follow-up consultations revealed cataract progression, retinal detachment, uveitis and secondary glaucoma. Whole genome sequence filtered variants private to the case, shared with another Old English Sheepdog genome and predicted to be deleterious were genotyped in an initial cohort of six Old English Sheepdogs (three affected by multiocular defect and three control dogs without evidence of inherited eye disease). Only one of the twenty-two variants segregated correctly with multiocular defect. The variant is a single nucleotide substitution, located in the collagen-type gene COL11A1, c.1775T>C, that causes an amino acid change, p.Phe1592Ser. Genotyping of an additional 14 Old English Sheepdogs affected by multiocular defect revealed a dominant mode of inheritance with four cases heterozygous for the variant. Further genotyping of hereditary cataract-affected Old English Sheepdogs revealed segregation of the variant in eight out of nine dogs. In humans, variants in the COL11A1 gene are associated with Stickler syndrome type II, also dominantly inherited.
☐ ☆ ✇ PLOS ONE Medicine&Health

Impaired health-related quality of life due to elevated risk of developing diabetes: A cross-sectional study in Indonesia

by M. Rifqi Rokhman, Bustanul Arifin, Benedetta Broggi, Anne-Fleur Verhaar, Zulkarnain Zulkarnain, Satibi Satibi, Dyah Aryani Perwitasari, Cornelis Boersma, Qi Cao, Maarten J. Postma, Jurjen van der Schans

Background

This study investigated the association between elevated risk of developing diabetes and impaired health-related quality of life (HRQoL) in the Indonesian population.

Methods

A cross-sectional study was conducted on 1,336 Indonesians from the general population who had no previous diagnosis of diabetes. Utility score to represent HRQoL was measured using the EuroQol 5-dimension, while the risk for developing diabetes was determined using the Finnish Diabetes Risk Score (FINDRISC) instrument. All participants underwent a blood glucose test after fasting for 8 hours. The association between FINDRISC score and HRQoL adjusted for covariates was analysed using multivariate Tobit regression models. Minimal clinically important differences were used to facilitate interpretation of minimal changes in utility score that could be observed.

Results

The median (interquartile range) of the overall FINDRISC score was 6 (7), while the mean (95% confidence intervals) of the EQ-5D utility score was 0.93 (0.93–0.94). Once adjusted for clinical parameters and socio-demographic characteristics, participants with a higher FINDRISC score showed a significantly lower HRQoL. No significant association was detected between fasting blood glucose level categories and HRQoL. A difference of 4–5 points in the FINDRISC score was considered to reflect meaningful change in HRQoL in clinical practice.

Conclusion

An elevated risk of developing diabetes is associated with a lower HRQoL. Therefore, attention should be paid not only to patients who have already been diagnosed with diabetes, but also to members of the general population who demonstrate an elevated risk of developing diabetes. This approach will assist in preventing the onset of diabetes and any further deterioration of HRQoL in this segment of the Indonesian population.

☐ ☆ ✇ PLOS ONE Medicine&Health

Post-stress changes in the gut microbiome composition in rats with different levels of nervous system excitability

by Alla Shevchenko, Irina Shalaginova, Dmitriy Katserov, Ludmila Matskova, Natalia Shiryaeva, Natalia Dyuzhikova

The gut-brain axis is a critical communication system influencing the interactions between the gastrointestinal tract (GI) and the central nervous system (CNS). The gut microbiota plays a significant role in this axis, affecting the development and function of the nervous system. Stress-induced psychopathologies, such as depression and anxiety, have been linked to the gut microbiota, but underlying mechanisms and genetic susceptibility remain unclear. In this study, we examined stress-induced changes in the gut microbiome composition in two rat strains with different levels of nervous system excitability: high threshold (HT strain) and low threshold (LT strain). Rats were exposed to long-term emotional and painful stress using the Hecht protocol, and fecal samples were collected at multiple time points before and after stress exposure. Using 16S rRNA amplicon sequencing, we assessed the qualitative and quantitative changes in the gut microbiota. Our results revealed distinct microbial diversity between the two rat strains, with the HT strain displaying higher diversity compared to the LT strain. Notably, under prolonged stress, the HT strain showed an increase in relative abundance of microorganisms from the genera Faecalibacterium and Prevotella in fecal samples. Additionally, both strains exhibited a decrease in Lactobacillus abundance following stress exposure. Our findings provide valuable insights into the impact of hereditary nervous system excitability on the gut microbiome composition under stress conditions. Understanding the gut-brain interactions in response to stress may open new avenues for comprehending stress-related psychopathologies and developing potential therapeutic interventions targeted at the gut microbiota. However, further research is needed to elucidate the exact mechanisms underlying these changes and their implications for stress-induced disorders. Overall, this study contributes to the growing body of knowledge on the gut-brain axis and its significance in stress-related neurobiology.
☐ ☆ ✇ BMJ Open

Characteristics of patients attached to near-retirement family physicians: a population-based serial cross-sectional study in Ontario, Canada

Por: Premji · K. · Green · M. E. · Glazier · R. H. · Khan · S. · Schultz · S. E. · Mathews · M. · Nastos · S. · Frymire · E. · Ryan · B. L. — Diciembre 7th 2023 at 23:50
Objectives

Population ageing is a global phenomenon. Resultant healthcare workforce shortages are anticipated. To ensure access to comprehensive primary care, which correlates with improved health outcomes, equity and costs, data to inform workforce planning are urgently needed. We examined the medical and social characteristics of patients attached to near-retirement comprehensive primary care physicians over time and explored the early-career and mid-career workforce’s capacity to absorb these patients.

Design

A serial cross-sectional population-based analysis using health administrative data.

Setting

Ontario, Canada, where most comprehensive primary care is delivered by family physicians (FPs) under universal insurance.

Participants

All insured Ontario residents at three time points: 2008 (12 936 360), 2013 (13 447 365) and 2019 (14 388 566) and all Ontario physicians who billed primary care services (2008: 11 566; 2013: 12 693; 2019: 15 054).

Outcome measures

The number, proportion and health and social characteristics of patients attached to near-retirement age comprehensive FPs over time; the number, proportion and characteristics of near-retirement age comprehensive FPs over time. Secondary outcome measures: The characteristics of patients and their early-career and mid-career comprehensive FPs.

Results

Patient attachment to comprehensive FPs increased over time. The overall FP workforce grew, but the proportion practicing comprehensiveness declined (2008: 77.2%, 2019: 70.7%). Over time, an increasing proportion of the comprehensive FP workforce was near retirement age. Correspondingly, an increasing proportion of patients were attached to near-retirement physicians. By 2019, 13.9% of comprehensive FPs were 65 years or older, corresponding to 1 695 126 (14.8%) patients. Mean patient age increased, and all physicians served markedly increasing numbers of medically and socially complex patients.

Conclusions

The primary care sector faces capacity challenges as both patients and physicians age and fewer physicians practice comprehensiveness. Nearly 15% (1.7 million) of Ontarians may lose their comprehensive FP to retirement between 2019 and 2025. To serve a growing, increasingly complex population, innovative solutions are needed.

☐ ☆ ✇ PLOS ONE Medicine&Health

Women Veterans’ perspectives, experiences, and preferences for firearm lethal means counseling discussions

by Evan R. Polzer, Ryan Holliday, Carly M. Rohs, Suzanne M. Thomas, Christin N. Miller, Joseph A. Simonetti, Lisa A. Brenner, Lindsey L. Monteith

Aims

Firearms have become an increasingly common method of suicide among women Veterans, yet this population has rarely been a focus in firearm suicide prevention research. Limited knowledge is available regarding the preferences, experiences, or needs of women Veterans with respect to firearm lethal means counseling (LMC), an evidence-based suicide prevention strategy. Understanding is necessary to optimize delivery for this population.

Method

Our sample included forty women Veterans with lifetime suicidal ideation or suicide attempt(s) and firearm access following military separation, all enrolled in the Veterans Health Administration. Participants were interviewed regarding their perspectives, experiences, and preferences for firearm LMC. Data were analyzed using a mixed inductive-deductive thematic analysis.

Results

Women Veterans’ firearm and firearm LMC perspectives were shaped by their military service histories and identity, military sexual trauma, spouses/partners, children, rurality, and experiences with suicidal ideation and attempts. Half reported they had not engaged in firearm LMC previously. For those who had, positive aspects included a trusting, caring relationship, direct communication of rationale for questions, and discussion of exceptions to confidentiality. Negative aspects included conversations that felt impersonal, not sufficiently comprehensive, and Veterans’ fears regarding implications of disclosure, which impeded conversations. Women Veterans’ preferences for future firearm LMC encompassed providers communicating why such conversations are important, how they should be framed (e.g., around safety and genuine concern), what they should entail (e.g., discussing concerns regarding disclosure), whom should initiate (e.g., trusted caring provider) and where they should occur (e.g., safe spaces, women-specific groups comprised of peers).

Discussion

This study is the first to examine women Veterans’ experiences with, and preferences for, firearm LMC. Detailed inquiry of the nuances of how, where, why, and by whom firearms are stored and used may help to facilitate firearm LMC with women Veterans.

☐ ☆ ✇ PLOS ONE Medicine&Health

Mental health status of pregnant women during COVID-19 in healthcare centers of Iran: A cross-sectional study

Por: Masoumeh Sayahi · Maryam Nikbina · Azam Jahangirimehr · Barat Barati — Noviembre 28th 2023 at 15:00

by Masoumeh Sayahi, Maryam Nikbina, Azam Jahangirimehr, Barat Barati

Background and objective

The COVID-19 pandemic impacted every single aspect of life. In addition to being a public health emergency, the COVID-19 outbreak impacted the mental health of individuals, especially pregnant women. This study aimed to examine the mental health status of pregnant women and also the effect of sociodemographic factors on their mental health status during COVID-19 in healthcare centers of Iran.

Methods

This cross-sectional, analytical-descriptive study was conducted among pregnant women referring to healthcare centers in Shoushtar, Iran, in 2021. Multistage cluster sampling was used to select participants. Data were collected using the General Health Questionnaire-28 (GHQ-28). Data were analyzed using SPSS software version 22. The Pearson correlation coefficient was used to examine the association between quantitative variables. A generalized linear model (GLM) was applied to estimate the effect of independent variables on the dependent variable (mental health).

Results

A total of 197 participants with a mean ± SD age of 27.85 ± 6.37 years took part in this study. The total mean score of mental health was estimated at 17.47±8.20. The highest mean ± SD score was, respectively, related to social dysfunction (6.63 ± 2.86), anxiety and insomnia (5.28 ± 3.53), and somatic symptoms (4.17 ± 3.27). Mental health disorder was significantly correlated with participants’ age (R = .223, P = .00), number of pregnancy (gravida) (R = .272, P = .00), number of births (para) (R = 0.272, P = .00), and number of abortions (R = .172, P = .015). About 80% of pregnant women did not reveal impaired mental health conditions or psychological distress, while 19.3% showed scores that indicate probable mental health conditions.

Conclusion

Social dysfunction was the most common mental health problem among pregnant women. It is necessary to pay more attention to the mental health status of pregnant women during a pandemic. Interventions such as practical strategies to promote social support and improve pregnant women’s mental health during pregnancy are highly important.

☐ ☆ ✇ PLOS ONE Medicine&Health

Predicting need for heart failure advanced therapies using an interpretable tropical geometry-based fuzzy neural network

by Yufeng Zhang, Keith D. Aaronson, Jonathan Gryak, Emily Wittrup, Cristian Minoccheri, Jessica R. Golbus, Kayvan Najarian

Background

Timely referral for advanced therapies (i.e., heart transplantation, left ventricular assist device) is critical for ensuring optimal outcomes for heart failure patients. Using electronic health records, our goal was to use data from a single hospitalization to develop an interpretable clinical decision-making system for predicting the need for advanced therapies at the subsequent hospitalization.

Methods

Michigan Medicine heart failure patients from 2013–2021 with a left ventricular ejection fraction ≤ 35% and at least two heart failure hospitalizations within one year were used to train an interpretable machine learning model constructed using fuzzy logic and tropical geometry. Clinical knowledge was used to initialize the model. The performance and robustness of the model were evaluated with the mean and standard deviation of the area under the receiver operating curve (AUC), the area under the precision-recall curve (AUPRC), and the F1 score of the ensemble. We inferred membership functions from the model for continuous clinical variables, extracted decision rules, and then evaluated their relative importance.

Results

The model was trained and validated using data from 557 heart failure hospitalizations from 300 patients, of whom 193 received advanced therapies. The mean (standard deviation) of AUC, AUPRC, and F1 scores of the proposed model initialized with clinical knowledge was 0.747 (0.080), 0.642 (0.080), and 0.569 (0.067), respectively, showing superior predictive performance or increased interpretability over other machine learning methods. The model learned critical risk factors predicting the need for advanced therapies in the subsequent hospitalization. Furthermore, our model displayed transparent rule sets composed of these critical concepts to justify the prediction.

Conclusion

These results demonstrate the ability to successfully predict the need for advanced heart failure therapies by generating transparent and accessible clinical rules although further research is needed to prospectively validate the risk factors identified by the model.

☐ ☆ ✇ International Wound Journal

Prevalence of surgical wound infection and related factors in patients after long bone surgery: A systematic review and meta‐analysis

Abstract

The goal of this systematic review and meta-analysis is to provide an overview of the prevalence of surgical wound infection and related factors in patients after long bone surgery. A comprehensive, systematic search was conducted in different international electronic databases, such as Scopus, PubMed, Web of Science and Persian electronic databases such as Iranmedex and Scientific Information Database using keywords extracted from Medical Subject Headings such as “Prevalence”, “Surgical wound infection”, “Surgical site infection” and “Orthopedics” from the earliest to the May 1, 2023. The appraisal tool for cross-sectional studies (AXIS tool) evaluates the quality of the included studies. A total of 71 854 patients undergoing long bone surgery participated in 12 studies. The pooled prevalence of surgical wound infection in patients who underwent long bone surgery reported in the 12 studies was 3.3% (95% CI: 1.5%–7.2%; I 2 = 99.39%; p < 0.001). The pooled prevalence of surgical wound infection in male and female patients who underwent long bone surgery was 4.6% (95% CI: 1.7%–11.7%; p < 0.001; I 2 = 99.34%) and 2.6% (95% CI: 1.0%–6.3%; I 2 = 98.84%; p < 0.001), respectively. The pooled prevalence of surgical wound infection in patients with femur surgery sites reported in nine studies was 3.7% (95% CI: 2.1–6.4%; I 2 = 93.43%; p < 0.001). The pooled prevalence of surgical wound infection in open and close fractures was 16.4% (95% CI: 8.2%–30.2%; I 2 = 95.83%; p < 0.001) and 2.9% (95% CI: 1.5%–5.5%; I 2 = 96.40%; p < 0.001), respectively. The pooled prevalence of surgical wound infection in patients with diabetes mellitus (DM), hypertension (HTN) and cardiovascular disease (CVD) was 4.6% (95% CI: 2.3%–8.9%; I 2 = 81.50%; p < 0.001), 2.7% (95% CI: 1.2%–6.0%; I 2 = 83.82%; p < 0.001) and 3.0% (95% CI: 1.4%–6.4%; I 2 = 69.12%; p = 0.006), respectively. In general, the different prevalence of surgical wound infection in patients undergoing surgical treatment after long bone fracture may be caused by underlying factors (gender and co-morbidity) and fracture-related factors (surgery site and type of fracture).

☐ ☆ ✇ BMJ Open

Solutions to Enhance Health with Alternative Treatments (SEHAT) protocol: a double-blinded randomised controlled trial for gut microbiota-targeted treatment of severe acute malnutrition using rice bran in ready-to-use therapeutic foods in Indonesia

Por: Weber · A. M. · Barbazza · S. · Fauzi · M. D. · Rachmadewi · A. · Zuhrina · R. · Putri · F. K. · Campos Ponce · M. · Hoeven · M. v. d. · Rimbawan · R. · Nasution · Z. · Giriwono · P. E. · Wieringa · F. T. · Soekarjo · D. D. · Ryan · E. P. — Noviembre 24th 2023 at 17:10
Introduction

Current formulations of ready-to-use therapeutic foods (RUTFs) to treat severe acute malnutrition (SAM) in children focus on nutrient density and quantity. Less attention is given to foods targeting gut microbiota metabolism and mucosal barrier functions. Heat-stabilised rice bran contains essential nutrients, prebiotics, vitamins and unique phytochemicals that have demonstrated favourable bioactivity to modulate gut microbiota composition and mucosal immunity. This study seeks to examine the impact of RUTF with rice bran on the microbiota during SAM treatment, recovery and post-treatment growth outcomes in Jember, Indonesia. Findings are expected to provide insights into rice bran as a novel food ingredient to improve SAM treatment outcomes.

Methods and analysis

A total of 200 children aged 6–59 months with uncomplicated SAM (weight-for-height z-scores (WHZ)

Ethics and dissemination

The findings of this trial will be submitted to peer-reviewed journals and will be presented at relevant conferences. Ethics approval obtained from the Medical and Health Research Ethical Committee at the Faculty of Medicine, Public Health and Nursing, Universitas Gadjah Madain Yogyakarta Ref. No.: KE/FK/0546/EC/2022 and KE/FK/0703/EC/2023 and from Colorado State University IRB#1823, OHRP FWA00000647.

Trial registration number

NCT05319717.

☐ ☆ ✇ BMJ Open

Effectiveness of a midwife-led continuity of care model on birth outcomes and maternal mental health in vulnerable women: study protocol for a randomised controlled trial with an internal pilot, process evaluation and economic analysis

Por: Willan · K. · Moss · R. H. · Santorelli · G. · Ahern · S. · Bryant · M. · Bywater · T. · Blower · S. L. · Richardson · G. · Hinde · S. · Huo · D. · Wright · J. · Dickerson · J. · Innovation Hub · B. S. B. — Noviembre 23rd 2023 at 17:23
Introduction

Women from social disadvantage are at greater risk of poor birth outcomes. The midwife-led continuity of care (MCC) model, which offers flexible and relational care from a small team of midwives, has demonstrated improved birth outcomes. In the general population, the impact of MCC on socially disadvantaged women and on birth outcomes is still unclear. This protocol describes a pragmatic evaluation of the MCC model in a socially disadvantaged population.

Methods and analysis

An open-labelled individual prospective randomised controlled trial with an internal pilot, process evaluation and economic analysis, from 1 April 2022 to 31 March 2024.

Women will be randomly allocated to MCC or standard care as part of usual midwifery practice. Participants and midwives will not be blinded, but researchers will be. An internal pilot will test the feasibility of this process.

Participants are those randomised into MCC or standard care, who consent to participate in one of two Born in Bradford (BiB) birth cohort studies. Outcomes are taken from routinely linked health data, supplemented by additional data capture. The sample size is fixed by the capacity of MCC teams, commissioning duration and numbers recruited into the cohort. The estimated maximum fixed sample size is 1,410 pregnancies (minimum 734).

Intention to treat (ITT) analysis will be undertaken to assess the impact of MCC on two independent primary outcomes. An economic evaluation will explore the impact on health resource use and a process evaluation will explore fidelity to the MCC model, and barriers/facilitators to implementation from midwives’ and women’s perspectives.

Ethics and dissemination

Ethical approval has been obtained for the randomisation in midwifery practice, use of the cohort data for evaluation and for the process evaluation. Findings will be published in peer-reviewed journals, presented at conferences and translated into policy briefings.

Trial registration number

IsRCTNhttps://doi.org/10.1186/ISRCTN31836167

☐ ☆ ✇ BMJ Open

Exploring the outcomes of research engagement using the observation method in an online setting

Por: Marshall · D. A. · Suryaprakash · N. · Lavallee · D. C. · Barker · K. L. · Mackean · G. · Zelinsky · S. · McCarron · T. L. · Santana · M. J. · Moayyedi · P. · Bryan · S. — Noviembre 21st 2023 at 17:16
Objective

The objective of this study was to explore the outcomes of research engagement (patient engagement, PE) in the context of qualitative research.

Design

We observed engagement in two groups comprised of patients, clinicians and researchers tasked with conducting a qualitative preference exploration project in inflammatory bowel disease. One group was led by a patient research partner (PLG, partner led group) and the other by an academic researcher (RLG, researcher led group). A semistructured guide and a set of critical outcomes of research engagement were used as a framework to ground our analysis.

Setting

The study was conducted online.

Participants

Patient research partners (n=5), researchers (n=5) and clinicians (n=4) participated in this study.

Main outcome measures

Transcripts of meetings, descriptive and reflective observation data of engagement during meetings and email correspondence between group members were analysed to identify the outcomes of PE.

Results

Both projects were patient-centred, collaborative, meaningful, rigorous, adaptable, ethical, legitimate, understandable, feasible, timely and sustainable. Patient research partners (PRPs) in both groups wore dual hats as patients and researchers and influenced project decisions wearing both hats. They took on advisory and operational roles. Collaboration seemed easier in the PLG than in the RLG. The RLG PRPs spent more time than their counterparts in the PLG sharing their experience with biologics and helping their group identify a meaningful project question. A formal literature review informed the design, project materials and analysis in the RLG, while the formal review informed the project materials and analysis in the PLG. A PRP in the RLG and the PLG lead leveraged personal connections to facilitate recruitment. The outcomes of both projects were meaningful to all members of the groups.

Conclusions

Our findings show that engagement of PRPs in research has a positive influence on the project design and delivery in the context of qualitative research in both the patient-led and researcher-led group.

☐ ☆ ✇ PLOS ONE Medicine&Health

Dietary replacement of soybean meal with black soldier fly larvae meal in juvenile <i>Labeo rohita</i> and <i>Catla catla</i>: Effects on growth, nutritional quality, oxidative stress biomarkers and disease resistance

Por: Shafaq Fatima · Ayesha Afzal · Hamna Rashid · Saba Iqbal · Rosheen Zafar · Komal Khalid · Ayman Rauf · Maryam Majeed · Aqsa Malik · Chris G. Carter — Noviembre 20th 2023 at 15:00

by Shafaq Fatima, Ayesha Afzal, Hamna Rashid, Saba Iqbal, Rosheen Zafar, Komal Khalid, Ayman Rauf, Maryam Majeed, Aqsa Malik, Chris G. Carter

This experiment aimed to investigate the effects of partial substitution of crude protein from soybean meal (SBM) with black soldier fly (Hermetia illucens) larvae meal (BSFLM) in juvenile rohu (Labeo rohita) and catla (Catla catla). Four isonitrogenous diets (23% crude protein) were formulated to replace 0% (T0), 40% (T40), 80% (T80) and 100% (T100) crude protein from SBM with BSFLM. Triplicate groups of each species (10 fish per replicate) were fed in an eight week growth experiment. After final sampling (n = 20 fish per dietary group), the remaining fish were exposed to bacterial (Staphylococcus aureus) challenge (0.80 CFU/ml) for 15 days. Rohu fed with BSFLM substituted diets showed significantly higher growth and feed conversion ratio as compared to those in T0. Catla fed with BSFLM substituted diets showed slightly higher growth indices. The growth response of rohu to BSFLM substitution was better than that noted in catla in all groups. The chemical composition, amino acids and fatty acids profile, haematological and biochemical parameters, levels of liver function enzymes measured in T0, T40, T80 and T100 were similar between four dietary groups in both species. However, the maximum value of cholesterol and triglycerides were noted in T100 both in catla and rohu. The values of lauric acid, α-linolenic acid, decosahexanoic acid, n3:n6 fatty acids ratio progressively increased with dietary increase of BSFLM in both species. At end of the growth experiment, the levels of catalase, superoxide dismutase and lysozyme increased linearly with the inclusion of BSFLM in both species while malondialdehyde showed similar values between different groups. However, catalase, and superoxide dismutase increased (T0
☐ ☆ ✇ BMJ Open

Association of antecedent statin use on 30-day, 60-day and 90-day mortality among Mississippi Medicaid beneficiaries diagnosed with COVID-19

Por: Rong · Y. · Goswami · S. · Eriakha · O. · Ramachandran · S. · Bentley · J. · Banahan · B. F. · Kirby · T. · Smith · D. · Pittman · E. · Bhattacharya · K. — Noviembre 20th 2023 at 06:50
Objective

To assess if the antecedent statin use was associated with all-cause death among COVID-19 patients enrolled in Medicaid.

Design

Cohort study.

Setting

Mississippi Medicaid population.

Participants

This study included 10 792 Mississippi Medicaid-enrolled patients between 18 and 64 years of age with a confirmed COVID-19 diagnosis from March 2020 to June 2021.

Intervention

Antecedent statin use, which was determined by a record of statin prescription in the 90-day period prior to the COVID diagnosis.

Main outcome measures

The outcomes of interest included mortality from all cause within 30 days, 60 days and 90 days after index.

Results

A total of 10 792 patients with COVID-19 met the inclusion and exclusion criteria, with 13.1% of them being antecedent statin users. Statin users were matched 1:1 with non-users based on age, sex, race, comorbidities and medication use by propensity score matching. In total, the matched cohort consisted of 1107 beneficiaries in each group. Multivariable logistic regression showed that statin users were less likely to die within 30 days (adjusted OR: 0.51, 95% CI: 0.32 to 0.83), 60 days (OR: 0.56, 95% CI: 0.37 to 0.85) and 90 days (OR: 0.55, 95% CI: 0.37 to 0.82) after diagnosis of COVID-19. Those with low-intensity/moderate-intensity statin use had significantly lower mortality risk in the 60-day and the 90-day follow-up period, while the high intensity of statin use was only found to be significantly associated with a lower odd of mortality within 30 days post index.

Conclusion

After COVID infection, Medicaid beneficiaries who had taken statins antecedently could be at lower risk for death. For patients with chronic conditions, continuity of care is crucial when interruptions occur in their medical care. Further research is required to further investigate the potential mechanisms and optimal use of statins in COVID-19 treatment.

☐ ☆ ✇ PLOS ONE Medicine&Health

Investigating the role of the relaxin-3/RXFP3 system in neuropsychiatric disorders and metabolic phenotypes: A candidate gene approach

Por: Win Lee Edwin Wong · Ryan Arathimos · Cathryn M. Lewis · Allan H. Young · Gavin S. Dawe — Noviembre 15th 2023 at 15:00

by Win Lee Edwin Wong, Ryan Arathimos, Cathryn M. Lewis, Allan H. Young, Gavin S. Dawe

The relaxin-3/RXFP3 system has been implicated in the modulation of depressive- and anxiety-like behaviour in the animal literature; however, there is a lack of human studies investigating this signalling system. We seek to bridge this gap by leveraging the large UK Biobank study to retrospectively assess genetic risk variants linked with this neuropeptidergic system. Specifically, we conducted a candidate gene study in the UK Biobank to test for potential associations between a set of functional, candidate single nucleotide polymorphisms (SNPs) pertinent to relaxin-3 signalling, determined using in silico tools, and several outcomes, including depression, atypical depression, anxiety and metabolic syndrome. For each outcome, we used several rigorously defined phenotypes, culminating in subsample sizes ranging from 85,881 to 386,769 participants. Across all outcomes, there were no associations between any candidate SNP and any outcome phenotype, following corrections for multiple testing burden. Regression models comprising several SNPs per relevant candidate gene as exploratory variables further exhibited no prediction of outcome. Our findings corroborate conclusions from previous literature about the limitations of candidate gene approaches, even when based on firm biological hypotheses, in the domain of genetic research for neuropsychiatric disorders.
☐ ☆ ✇ Worldviews on Evidence-Based Nursing

A meta‐analysis of mindfulness‐based interventions for improving mental health and burden among caregivers of persons living with dementia

Abstract

Background

Mindfulness-based interventions are becoming increasingly popular and are effective in lowering depressive symptoms and caregiver burden. However, the overall efficacy of therapies in stress and anxiety management is unreported, and no study to date has performed a subgroup analysis to investigate the intervention dose response of outcomes.

Aims

To quantitatively identify the effectiveness of mindfulness-based interventions for caregivers of persons living with dementia.

Methods

A comprehensive literature search of six databases was undertaken from the date of inception to June 18, 2023. The DerSimonian–Laird model with random effects was used to examine the overall effect and its heterogeneity in the studies. Version 2 of the risk of bias (RoB 2) tool was employed to analyze the publication bias of each randomized study. Funnel and forest plots were created to represent the findings.

Results

Thirteen randomized trials were included in the meta-analysis. Mindfulness-based interventions significantly reduced stress and anxiety of caregivers of persons living with dementia. In addition, interventions provided for ≥8 weeks were beneficial in reducing depression in caregivers. However, mindfulness-based interventions did not offer significant benefits in reducing depression or caregiver burden immediately after the intervention.

Conclusion

Mindfulness-based interventions have the potential to help caregivers of people living with dementia. This study could be used as a model for future research into and implementation of mindfulness-based therapies for caregivers.

Linking Evidence to Action

Mindfulness-based therapies appear to alleviate stress and anxiety but are ineffective in reducing depression and burden in caregivers of persons living with dementia. Well-designed RCTs with more rigorous methodology and a larger sample size should be conducted to firm the conclusion of the effectiveness of mindfulness-based interventions for caregivers of persons living with dementia.

☐ ☆ ✇ Journal of Nursing Scholarship

Effects of mindfulness‐based interventions on reducing psychological distress among nurses: A systematic review and meta‐analysis of randomized controlled trials

Abstract

Purpose

Nurses increasingly use mindfulness as an effective mental health intervention to reduce psychological distress. The effectiveness of mindfulness-based interventions remains inconclusive, which may lead to implementation of interventions in an inefficient or ineffective manner. This study aimed to examine the effects of mindfulness-based interventions on reducing stress, anxiety, and depression among nurses.

Design

Systematic review and meta-analysis.

Methods

Randomized controlled trials (RCTs) were searched using six databases published through May 20, 2023, which evaluated the effects of mindfulness-based interventions on reducing psychological distress among nurses. To assess the quality of methodology included in the RCTs, version 2 of the Cochrane risk-of-bias instrument for RCTs with five domains was used. Standardized mean difference (SMD) with 95% confidence interval (CI) were calculated using the random–effects model in the meta-analyses. Publication bias was assessed using Egger's regression test. Further, the robustness effect size of the pooled analysis was assessed using leave-one-out sensitivity analysis.

Findings

A total of 16 RCTs were included in the final analysis. Overall, the modalities appeared to alleviate stress (pooled SMD: −0.50 [95% CI: −0.82 to −0.18]; p < 0.001) and depression (pooled SMD: −0.42 [95% CI: −0.78 to −0.06]; p = 0.02) among nurses.

Conclusion

Mindfulness-based interventions appear to alleviate stress and depression in nurses. Future research evaluating mindfulness-based interventions among working nurses with more rigorous methodological and larger sample size.

Clinical Relevance

Support for nurses' mental health must be included while implementing personal and professional development plans.

☐ ☆ ✇ Worldviews on Evidence-Based Nursing

The effect of nurse‐led telephone‐based interventions on glycosylated hemoglobin levels in people with type 2 diabetes: A meta‐analysis

Por: Merve Yuksel · Ferya Celik · Hicran Bektas — Octubre 28th 2023 at 10:44

Abstract

Background

Telenursing interventions can contribute to achieving optimal glycemic control.

Aim

This meta-analysis aimed to determine the effect of nurse-led telephone-based interventions on glycosylated hemoglobin (HbA1c) levels in people with type 2 diabetes.

Methods

We searched electronic databases for studies published in English up to January 2023. This study was conducted in accordance with the PRISMA 2020 checklist. The intervention effects were pooled using a random-effects model. Two authors independently assessed the risk of bias using the Cochrane Collaboration tool.

Results

Eight studies involving 1179 people with type 2 diabetes were included in this study. Interventions were performed for 15–30 min and 5–16 calls. There was no evidence of a significant publication bias. The evaluation of meta-analysis data showed that nurse-led telephone-based interventions significantly reduced HbA1c levels in people with type 2 diabetes (mean difference = −0.53, 95% Confidence Interval [−0.89, −0.17], p = .003).

Linking Evidence to Action

Nurse-led telephone-based interventions focused on reducing glycosylated hemoglobin levels in people with type 2 diabetes can be used as an effective intervention to achieve glycemic control. We recommend holding an average of 15–25 min interviews once or twice a week.

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