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☐ ☆ ✇ PLOS ONE Medicine&Health

Untargeted lipidomics analysis in women with morbid obesity and type 2 diabetes mellitus: A comprehensive study

Por: Laia Bertran · Jordi Capellades · Sonia Abelló · Carmen Aguilar · Teresa Auguet · Cristóbal Richart — Mayo 14th 2024 at 16:00

by Laia Bertran, Jordi Capellades, Sonia Abelló, Carmen Aguilar, Teresa Auguet, Cristóbal Richart

There is a phenotype of obese individuals termed metabolically healthy obese that present a reduced cardiometabolic risk. This phenotype offers a valuable model for investigating the mechanisms connecting obesity and metabolic alterations such as Type 2 Diabetes Mellitus (T2DM). Previously, in an untargeted metabolomics analysis in a cohort of morbidly obese women, we observed a different lipid metabolite pattern between metabolically healthy morbid obese individuals and those with associated T2DM. To validate these findings, we have performed a complementary study of lipidomics. In this study, we assessed a liquid chromatography coupled to a mass spectrometer untargeted lipidomic analysis on serum samples from 209 women, 73 normal-weight women (control group) and 136 morbid obese women. From those, 65 metabolically healthy morbid obese and 71 with associated T2DM. In this work, we find elevated levels of ceramides, sphingomyelins, diacyl and triacylglycerols, fatty acids, and phosphoethanolamines in morbid obese vs normal weight. Conversely, decreased levels of acylcarnitines, bile acids, lyso-phosphatidylcholines, phosphatidylcholines (PC), phosphatidylinositols, and phosphoethanolamine PE (O-38:4) were noted. Furthermore, comparing morbid obese women with T2DM vs metabolically healthy MO, a distinct lipid profile emerged, featuring increased levels of metabolites: deoxycholic acid, diacylglycerol DG (36:2), triacylglycerols, phosphatidylcholines, phosphoethanolamines, phosphatidylinositols, and lyso-phosphatidylinositol LPI (16:0). To conclude, analysing both comparatives, we observed decreased levels of deoxycholic acid, PC (34:3), and PE (O-38:4) in morbid obese women vs normal-weight. Conversely, we found elevated levels of these lipids in morbid obese women with T2DM vs metabolically healthy MO. These profiles of metabolites could be explored for the research as potential markers of metabolic risk of T2DM in morbid obese women.
☐ ☆ ✇ Journal of Advanced Nursing

Nursing assessment of mental health issues in the general clinical environment: A descriptive study

Abstract

Aims

To evaluate the effectiveness of a mental health screening form for early identification and care escalation of mental health issues in general settings. A secondary aim was to explore general nurses' use of the form and their confidence to discuss mental health issues with patients.

Methods

A cross-sectional design comprising a review of clinical records to determine use of the form, instances of missed care and escalation to the mental health team. The survey focused on nurses' confidence in general settings to engage in discussions with patients about mental health. Data were collected from April to December 2022. The Strengthening the Reporting of Observational Studies in Epidemiology Statement guided this study.

Results

Of 400 patient records, 397 were analysed; 293 (73.8%) of those had mental health screening by nurses. Age was a significant factor, with younger patients more likely to be screened although concerns were typically recognized in older patients. Of the 20 patients identified with mental health concerns, 9 (45%) were referred for further evaluation by the Clinical Liaison Team. While nurses were proactive in assessing physical risks, assessing risk factors that required deeper conversations with patients, including psychiatric history, was lacking. The survey highlighted fewer than half of the respondents (46%, n = 10) felt competent to engage in discussions about mental health; however, most (59%, n = 13) knew when to seek a mental health referral.

Conclusions

General nurses have a role in the early identification and referral of patients with mental health challenges. However, training is imperative to facilitate deeper patient interactions concerning mental health. Integrating mental health checks within general settings is crucial for early detection and intervention, aligning with global quality care standards.

Reporting Method

STROBE guidelines.

Patient or Public Contribution

We received feedback that shaped the research protocol from a consumer representative.

☐ ☆ ✇ BMJ Open

Low-dose naltrexone for post-COVID fatigue syndrome: a study protocol for a double-blind, randomised trial in British Columbia

Por: Naik · H. · Cooke · E. · Boulter · T. · Dyer · R. · Bone · J. N. · Tsai · M. · Cristobal · J. · McKay · R. J. · Song · X. · Nacul · L. — Mayo 14th 2024 at 01:39
Introduction

A significant proportion of individuals suffering from post COVID-19 condition (PCC, also known as long COVID) can present with persistent, disabling fatigue similar to myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and post-viral fatigue syndromes. There remains no clear pharmacological therapy for patients with this subtype of PCC, which can be referred to as post-COVID fatigue syndrome (PCFS). A low dose of the opioid antagonist naltrexone (ie, low-dose naltrexone (LDN)) has emerged as an off-label treatment for treating fatigue and other symptoms in PCC. However, only small, non-controlled studies have assessed LDN in PCC, so randomised trials are urgently required.

Methods and analysis

A prospective, randomised, double-blind, parallel arm, placebo-controlled phase II trial will be performed to assess the efficacy of LDN for improving fatigue in PCFS. The trial will be decentralised and open to eligible individuals throughout the Canadian province of British Columbia (BC). Participants will be recruited through the province-wide Post-COVID-19 Interdisciplinary Clinical Care Network (PC-ICCN) and research volunteer platform (REACH BC). Eligible participants will be 19–69 years old, have had a confirmed or physician-suspected SARS-CoV-2 infection at least 3 months prior and meet clinical criteria for PCFS adapted from the Institute of Medicine ME/CFS criteria. Individuals who are taking opioid medications, have a history of ME/CFS prior to COVID-19 or history of significant liver disease will be excluded. Participants will be randomised to an LDN intervention arm (n=80) or placebo arm (n=80). Participants in each arm will be prescribed identical capsules starting at 1 mg daily and follow a prespecified schedule for up-titration to 4.5 mg daily or the maximum tolerated dose. The trial will be conducted over 16 weeks, with assessments at baseline, 6, 12 and 16 weeks. The primary outcome will be fatigue severity at 16 weeks evaluated by the Fatigue Severity Scale. Secondary outcomes will include pain Visual Analogue Scale score, overall symptom severity as measured by the Patient Phenotyping Questionnaire Short Form, 7-day step count and health-related quality of life measured by the EuroQol 5-Dimension questionnaire.

Ethics and dissemination

The trial has been authorised by Health Canada and approved by The University of British Columbia/Children’s and Women’s Health Centre of British Columbia Research Ethics Board. On completion, findings will be disseminated to patients, caregivers and clinicians through engagement activities within existing PCC and ME/CFS networks. Results will be published in academic journals and presented at conferences.

Trial registration number

NCT05430152.

☐ ☆ ✇ BMJ Open

Patient, caregiver and other knowledge user engagement in consensus-building healthcare initiatives: a scoping review protocol

Por: Munce · S. E. P. · Wong · E. · Luong · D. · Rao · J. · Cunningham · J. · Bailey · K. · John · T. · Barber · C. · Batthish · M. · Chambers · K. · Cleverley · K. · Crabtree · M. · Diaz · S. · Dimitropoulos · G. · Gorter · J. W. · Grahovac · D. · Grimes · R. · Guttman · B. · Hebert · M. L. · He — Mayo 8th 2024 at 17:36
Introduction

Patient engagement and integrated knowledge translation (iKT) processes improve health outcomes and care experiences through meaningful partnerships in consensus-building initiatives and research. Consensus-building is essential for engaging a diverse group of experienced knowledge users in co-developing and supporting a solution where none readily exists or is less optimal. Patients and caregivers provide invaluable insights for building consensus in decision-making around healthcare, policy and research. However, despite emerging evidence, patient engagement remains sparse within consensus-building initiatives. Specifically, our research has identified a lack of opportunity for youth living with chronic health conditions and their caregivers to participate in developing consensus on indicators/benchmarks for transition into adult care. To bridge this gap and inform our consensus-building approach with youth/caregivers, this scoping review will synthesise the extent of the literature on patient and other knowledge user engagement in consensus-building healthcare initiatives.

Methods and analysis

Following the scoping review methodology from Joanna Briggs Institute, published literature will be searched in MEDLINE, EMBASE, CINAHL and PsycINFO databases from inception to July 2023. Grey literature will be hand-searched. Two independent reviewers will determine the eligibility of articles in a two-stage process, with disagreements resolved by a third reviewer. Included studies must be consensus-building studies within the healthcare context that involve patient engagement strategies. Data from eligible studies will be extracted and charted on a standardised form. Abstracted data will be analysed quantitatively and descriptively, according to specific consensus methodologies, and patient engagement models and/or strategies.

Ethics and dissemination

Ethics approval is not required for this scoping review protocol. The review process and findings will be shared with and informed by relevant knowledge users. Dissemination of findings will also include peer-reviewed publications and conference presentations. The results will offer new insights for supporting patient engagement in consensus-building healthcare initiatives.

Protocol registration

https://osf.io/beqjr

☐ ☆ ✇ BMJ Open

Factors influencing the outcomes of non-pharmacological interventions for managing fatigue across the lifespan of people living with musculoskeletal (MSK) conditions: a scoping review protocol

Por: Fishpool · K. · Young · G. · Ciurtin · C. · Cramp · F. · Erhieyovwe · E. O. · Farisogullari · B. · Macfarlane · G. J. · Machado · P. M. · Pearson · J. · Santos · E. · Dures · E. — Mayo 3rd 2024 at 16:08
Introduction

Fatigue is an important and distressing symptom for many people living with chronic musculoskeletal (MSK) conditions. Many non-pharmacological interventions have been investigated in recent years and some have been demonstrated to be effective in reducing fatigue and fatigue impact, however, there is limited guidance for clinicians to follow regarding the most appropriate management options. The objective of this scoping review is to understand and map the extent of evidence in relation to the factors that relate to the outcome of non-pharmacological interventions on MSK condition-related fatigue across the lifespan.

Methods and analysis

This scoping review will include evidence relating to people of all ages living with chronic MSK conditions who have been offered a non-pharmacological intervention with either the intention or effect of reducing fatigue and its impact. Databases including AMED, PsycINFO, CINAHLPlus, MEDLINE, EMBASE and Scopus will be searched for peer-reviewed primary research studies published after 1 January 2007 in English language. These findings will be used to identify factors associated with successful interventions and to map gaps in knowledge.

Ethics and dissemination

Ethical approval was not required for this review. Findings will be disseminated by journal publications, conference presentations and by communicating with relevant healthcare and charity organisations.

☐ ☆ ✇ BMJ Open

Comorbidity and multimorbidity in patients with cirrhosis, hospitalised in an internal medicine ward: a monocentric, cross-sectional study

Por: Lenti · M. V. · Ballesio · A. · Croce · G. · Brera · A. S. · Padovini · L. · Bertolino · G. · Di Sabatino · A. · Klersy · C. · Corazza · G. R. — Mayo 1st 2024 at 16:46
Objectives

There are no data regarding the prevalence of comorbidity (ie, additional conditions in reference to an index disease) and multimorbidity (ie, co-occurrence of multiple diseases in which no one holds priority) in patients with liver cirrhosis. We sought to determine the rate and differences between comorbidity and multimorbidity depending on the aetiology of cirrhosis.

Design

This is a subanalysis of the San MAtteo Complexity (SMAC) study. We have analysed demographic, clinical characteristics and rate of comorbidity/multimorbidity of patients with liver cirrhosis depending on the aetiology—alcoholic, infectious and non-alcoholic fatty liver disease (NAFLD). A multivariable analysis for factors associated with multimorbidity was fitted.

Setting

Single-centre, cross-sectional study conducted in a tertiary referral, academic, internal medicine ward in northern Italy (November 2017–November 2019).

Participants

Data from 1433 patients previously enrolled in the SMAC study were assessed; only those with liver cirrhosis were eventually included.

Results

Of the 1433 patients, 172 (median age 79 years, IQR 67–84; 83 females) had liver cirrhosis. Patients with cirrhosis displayed higher median Cumulative Illness Rating Scale (CIRS) comorbidity (4, IQR 3–5; p=0.01) and severity (1.85, IQR 16.–2.0; p3 (OR 2.81, 95% CI 1.14 to 6.93, p=0.024) and admission related to cirrhosis (OR 0.19, 95% CI 0.07 to 0.54, p=0.002) were the only significant associations.

Conclusions

Comorbidity is more common in alcohol cirrhosis compared with other aetiologies in a hospital, internal medicine setting.

☐ ☆ ✇ BMJ Open

Examining relationships between adverse childhood experiences and coping during the cost-of-living crisis using a national cross-sectional survey in Wales, UK

Por: Hughes · K. · Bellis · M. A. · Cresswell · K. · Hill · R. · Ford · K. · Hopkins · J. C. — Mayo 1st 2024 at 16:46
Objectives

Adverse childhood experiences (ACEs) can affect individuals’ resilience to stressors and their vulnerability to mental, physical and social harms. This study explored associations between ACEs, financial coping during the cost-of-living crisis and perceived impacts on health and well-being.

Design

National cross-sectional face-to-face survey. Recruitment used a random quota sample of households stratified by health region and deprivation quintile.

Setting

Households in Wales, UK.

Participants

1880 Welsh residents aged ≥18 years.

Measures

Outcome variables were perceived inability to cope financially during the cost-of-living crisis; rising costs of living causing substantial distress and anxiety; and self-reported negative impact of rising costs of living on mental health, physical health, family relationships, local levels of antisocial behaviour and violence, and community support. Nine ACEs were measured retrospectively. Socioeconomic and demographic variables included low household income, economic inactivity, residential deprivation and activity limitation.

Results

The prevalence of all outcomes increased strongly with ACE count. Perceived inability to cope financially during the cost-of-living crisis increased from 14.0% with 0 ACEs to 51.5% with 4+ ACEs. Relationships with ACEs remained after controlling for socioeconomic and demographic factors. Those with 4+ ACEs (vs 0 ACEs) were over three times more likely to perceive they would be unable to cope financially and, correspondingly, almost three times more likely to report substantial distress and anxiety and over three times more likely to report negative impacts on mental health, physical health and family relationships.

Conclusions

Socioeconomically deprived populations are recognised to be disproportionately impacted by rising costs of living. Our study identifies a history of ACEs as an additional vulnerability that can affect all socioeconomic groups. Definitions of vulnerability during crises and communications with services on who is most likely to be impacted should consider childhood adversity and history of trauma.

☐ ☆ ✇ BMJ Open

Novel point-of-care cytokine biomarker lateral flow test for the screening for sexually transmitted infections and bacterial vaginosis: study protocol of a multicentre multidisciplinary prospective observational clinical study to evaluate the performance

Por: Ramboarina · S. · Crucitti · T. · Gill · K. · Bekker · L. G. · Harding-Esch · E. M. · van de Wijgert · J. H. H. M. · Huynh · B.-T. · Fortas · C. · Harimanana · A. · Mayouya Gamana · T. · Randremanana · R. V. · Mangahasimbola · R. · Dziva Chikwari · C. · Kranzer · K. · Mackworth-You — Mayo 1st 2024 at 16:46
Introduction

A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care test—called the Genital InFlammation Test (GIFT)—for detecting genital inflammation associated with sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. In this paper, we describe the rationale and design for studies that will be conducted in South Africa, Zimbabwe and Madagascar to evaluate the performance of GIFT and how it could be integrated into routine care.

Methods and analysis

We will conduct a prospective, multidisciplinary, multicentre, cross-sectional and observational clinical study comprising two distinct components: a biomedical (‘diagnostic study’) and a qualitative, modelling and economic (‘an integration into care study’) part. The diagnostic study aims to evaluate GIFT’s performance in identifying asymptomatic women with discharge-causing STIs (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG)) and BV. Study participants will be recruited from women attending research sites and family planning services. Several vaginal swabs will be collected for the evaluation of cytokine concentrations (ELISA), STIs (nucleic acid amplification tests), BV (Nugent score) and vaginal microbiome characteristics (16S rRNA gene sequencing). The first collected vaginal swab will be used for the GIFT assay which will be performed in parallel by a healthcare worker in the clinic near the participant, and by a technician in the laboratory. The integration into care study aims to explore how GIFT could be integrated into routine care. Four activities will be conducted: user experiences and/or perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews with key stakeholders; discrete choice experiments; development of a decision tree classification algorithm; and economic evaluation of defined management algorithms.

Ethics and dissemination

Findings will be reported to participants, collaborators and local government for the three sites, presented at national and international conferences, and disseminated in peer-reviewed publications.

The protocol and all study documents such as informed consent forms were reviewed and approved by the University of Cape Town Human Research Ethics Committee (HREC reference 366/2022), Medical Research Council of Zimbabwe (MRCZ/A/2966), Comité d’Ethique pour la Recherche Biomédicale de Madagascar (N° 143 MNSAP/SG/AMM/CERBM) and the London School of Hygiene and Tropical Medicine ethics committee (LSHTM reference 28046).

Before the start, this study was submitted to the Clinicaltrials.gov public registry (NCT05723484).

Trial registration number

NCT05723484.

☐ ☆ ✇ Journal of Advanced Nursing

The application of antimicrobial stewardship knowledge to nursing practice: A national survey of United Kingdom pre‐registration nursing students

Abstract

Aim

To assess student nurses understanding and skills in the application of antimicrobial stewardship knowledge to practice.

Design

Quantitative.

Methods

Cross-sectional survey.

Results

Five hundred and twenty three student nurses responded across 23 UK universities. Although students felt prepared in competencies in infection prevention and control, patient-centred care and interprofessional collaborative practice, they felt less prepared in competencies in which microbiological knowledge, prescribing and its effect on antimicrobial stewardship is required. Problem-based learning, activities in the clinical setting and face-to-face teaching were identified as the preferred modes of education delivery. Those who had shared antimicrobial stewardship teaching with students from other professions reported the benefits to include a broader understanding of antimicrobial stewardship, an understanding of the roles of others in antimicrobial stewardship and improved interprofessional working.

Conclusion

There are gaps in student nurses' knowledge of the basic sciences associated with the antimicrobial stewardship activities in which nurses are involved, and a need to strengthen knowledge in pre-registration nurse education programmes pertaining to antimicrobial management, specifically microbiology and antimicrobial regimes and effects on antimicrobial stewardship. Infection prevention and control, patient-centred care and interprofessional collaborative practice are areas of antimicrobial stewardship in which student nurses feel prepared. Interprofessional education would help nurses and other members of the antimicrobial stewardship team clarify the role nurses can play in antimicrobial stewardship and therefore maximize their contribution to antimicrobial stewardship and antimicrobial management.

Implications for the Profession

There is a need to strengthen knowledge from the basic sciences, specifically pertaining to antimicrobial management, in pre-registration nurse education programmes.

Patient or Public Contribution

No patient or public contribution.

Impact

What Problem Did the Study Address?

Nurses must protect health through understanding and applying antimicrobial stewardship knowledge and skills (Nursing and Midwifery Council 2018); however, there is no research available that has investigated nurses understanding and skills of the basic sciences associated with the antimicrobial stewardship activities in which they are involved.

What Were the Main Findings?

There are gaps in student nurses' knowledge of the basic sciences (specifically microbiology and prescribing) associated with the antimicrobial stewardship activities in which nurses are involved. Problem-based learning, and activities in the clinical setting, were reported as useful teaching methods, whereas online learning, was seen as less useful.

Where and on Whom Will the Research Have an Impact?

Pre-registration nurse education programmes.

Reporting Method

The relevant reporting method has been adhered to, that is, STROBE.

☐ ☆ ✇ PLOS ONE Medicine&Health

Knowledge, attitudes, and practices about HIV and other sexually transmitted infections among High School students in Southern Italy: A cross-sectional survey

by Francesco Di Gennaro, Francesco Vladimiro Segala, Giacomo Guido, Mariacristina Poliseno, Laura De Santis, Alessandra Belati, Carmen Rita Santoro, Irene Francesca Bottalico, Carmen Pellegrino, Roberta Novara, Luisa Frallonardo, Mariangela Cormio, Michele Camporeale, Sergio Cotugno, Vincenzo Giliberti, Stefano Di Gregorio, Valentina Totaro, Nicola Catucci, Anna De Giosa, Roberta Giusto, Ilaria Viviana Lanera, Gioacchino Angarano, Sergio Lo Caputo, Annalisa Saracino

High School students, recognized as a high-risk group for sexually transmitted infections (STIs), were the focal point of an educational campaign in Southern Italy to share information and good practices about STIs and HIV/AIDS. A baseline survey comprising 76 items was conducted via the REDCap platform to assess students’ initial knowledge, attitudes, and practices (KAP) related to STIs and HIV/AIDS. Sociodemographic variables were also investigated. The association between variables and KAP score was assessed by Kruskal-Wallis’ or Spearman’s test, as appropriate. An ordinal regression model was built to estimate the effect size, reported as odds ratio (OR) with a 95% confidence interval (CI), for achieving higher KAP scores among students features. On a scale of 0 to 29, 1702 participants achieved a median KAP score of 14 points. Higher scores were predominantly reported by students from classical High Schools (OR 3.19, 95% C.I. 1.60–6.33, p
☐ ☆ ✇ PLOS ONE Medicine&Health

Tobacco price elasticity by socioeconomic characteristics in Ecuador

Por: Ana Cristina Mena · Guillermo Paraje — Abril 19th 2024 at 16:00

by Ana Cristina Mena, Guillermo Paraje

Smoking is a worldwide epidemic and increased prices are one of the most cost-effective measures to reduce tobacco consumption. This article aims to estimate the price and income elasticity of cigarettes for different population groups in Ecuador. The National Survey of Urban and Rural Household Income and Expenditures (ENIGHUR) 2011–2012 was used, which has information on household cigarette consumption and its sociodemographic characteristics. Deaton’s Almost Ideal Demand System, which decouples the effect of quality on the price of the good, was applied. The elasticities were calculated for several groups: urban/rural, income levels (tertiles), education level, sex and age ranges of the household head, and frequency of cigarette purchases in households. The estimated price elasticity nationwide is -0.89 and the income elasticity is 0.41, both statistically significant. Households headed by women (-2.22) are more sensitive to an increase in cigarette prices than those headed by men (-0.65) and households headed by people between 20 and 40 years of age (-2.32) have a higher price elasticity compared to country-level estimations. Differences within other groups are not statistically significant.
☐ ☆ ✇ PLOS ONE Medicine&Health

Changes in parenting behavior in the time of COVID—19: A mixed method approach

by Luiza Mesesan-Schmitz, Claudiu Coman, Carmen Stanciu, Venera Bucur, Laurentiu Gabriel Tiru, Maria Cristina Bularca

This study was designed to explore mothers’ perceptions about changes in parenting behavior in the middle of the pandemic COVID 19 period. Based on the convergent mixed-method design and Parental Stress model, we illustrated these changes by taking into account the impact of the pandemic perceived by mothers and the resources they had available. Research on parenting changes was important in the Romanian context because, in that challenging period, there were no regulations to safeguard parents, especially single parents as mothers. Mothers experienced increased levels of stress, some of them having to leave their jobs to stay at home with their children. Other mothers needed to work from home and in the meantime to take care of their children. In this context we wanted to illustrate the possible changes that occurred in their parenting behavior during the pandemic period. Results from the quantitative survey showed that there is a moderate correlation between the negative impact felt by mothers and the negative changes in their parenting behavior, and this correlation was diminished by a series of resources such as: social support, parenting alliance, or high income. Qualitative data provided better understanding of mothers’ parenting behavior by showing that mothers shared both positive and negative experiences during the pandemic, regardless of the general trend mentioned. As shown by the quantitative data, the qualitative data also showed that mothers who felt more strongly the impact of the pandemic reported more negative changes in their parenting behavior. The positive changes most frequently stated involved expressing affection and communicating more often on various topics, carrying out leisure activities or activities meant to help with the personal development of the child, and involving children in domestic activities. Mothers mostly described negative aspects such as too much involvement in school life, increased control and surveillance of children, especially when it comes to school related activities and to the time children were allowed to spend on their digital devices. These changes led to conflicts and sometimes, mothers resorted to discipline practices. In addition to the resources identified in quantitative research, mothers with higher education and medium–high income also turned to specialized resources (psychologists, online courses, support groups) in order to manage conflicts, them being able to see the challenges of the pandemic as an opportunity to develop and improve the relationship with their children.
☐ ☆ ✇ BMJ Open

Cohort profile: Worldwide Collaboration on OsteoArthritis prediCtion for the Hip (World COACH) - an international consortium of prospective cohort studies with individual participant data on hip osteoarthritis

Por: van Buuren · M. M. A. · Riedstra · N. S. · van den Berg · M. A. · Boel · F. D. E. M. · Ahedi · H. · Arbabi · V. · Arden · N. K. · Bierma-Zeinstra · S. M. A. · Boer · C. G. · Cicuttini · F. · Cootes · T. F. · Crossley · K. · Felson · D. · Gielis · W. P. · Heerey · J. · Jones · G. · Kluz — Abril 18th 2024 at 17:47
Purpose

Hip osteoarthritis (OA) is a major cause of pain and disability worldwide. Lack of effective therapies may reflect poor knowledge on its aetiology and risk factors, and result in the management of end-stage hip OA with costly joint replacement. The Worldwide Collaboration on OsteoArthritis prediCtion for the Hip (World COACH) consortium was established to pool and harmonise individual participant data from prospective cohort studies. The consortium aims to better understand determinants and risk factors for the development and progression of hip OA, to optimise and automate methods for (imaging) analysis, and to develop a personalised prediction model for hip OA.

Participants

World COACH aimed to include participants of prospective cohort studies with ≥200 participants, that have hip imaging data available from at least 2 time points at least 4 years apart. All individual participant data, including clinical data, imaging (data), biochemical markers, questionnaires and genetic data, were collected and pooled into a single, individual-level database.

Findings to date

World COACH currently consists of 9 cohorts, with 38 021 participants aged 18–80 years at baseline. Overall, 71% of the participants were women and mean baseline age was 65.3±8.6 years. Over 34 000 participants had baseline pelvic radiographs available, and over 22 000 had an additional pelvic radiograph after 8–12 years of follow-up. Even longer radiographic follow-up (15–25 years) is available for over 6000 of these participants.

Future plans

The World COACH consortium offers unique opportunities for studies on the relationship between determinants/risk factors and the development or progression of hip OA, by using harmonised data on clinical findings, imaging, biomarkers, genetics and lifestyle. This provides a unique opportunity to develop a personalised hip OA risk prediction model and to optimise methods for imaging analysis of the hip.

☐ ☆ ✇ BMJ Open

Fetal alcohol spectrum disorder and attention deficit hyperactivity disorder stimulant trial in children: an N-of-1 pilot trial to compare stimulant to placebo (FASST): protocol

Por: Crichton · A. · Harris · K. · McGree · J. M. · Nikles · J. · Anderson · P. J. · Williams · K. — Abril 17th 2024 at 17:18
Introduction

Fetal alcohol spectrum disorder (FASD) is a neurodevelopmental disorder caused by alcohol exposure during pregnancy. FASD is associated with neurodevelopmental deviations, and 50%–94% of children with FASD meet the Diagnostic and Statistical Manual of Mental Disorders-fifth edition diagnostic criteria for attention deficit hyperactivity disorder (ADHD). There is a paucity of evidence around medication efficacy for ADHD symptoms in children with FASD. This series of N-of-1 trials aims to provide pilot data on the feasibility of conducting N-of-1 trials in children with FASD and ADHD.

Methods and analysis

A pilot N-of-1 randomised trial design with 20 cycles of stimulant and placebo (four cycles of 2-week duration) for each child will be conducted (n=20) in Melbourne, Australia.

Feasibility and tolerability will be assessed using recruitment and retention rates, protocol adherence, adverse events and parent ratings of side effects. Each child’s treatment effect will be determined by analysing teacher ADHD ratings across stimulant and placebo conditions (Wilcoxon rank). N-of-1 data will be aggregated to provide an estimate of the cohort treatment effect as well as individual-level treatment effects. We will assess the sample size and number of cycles required for a future trial. Potential mediating factors will be explored to identify variables that might be associated with treatment response variability.

Ethics and dissemination

The study was approved by the Hospital and Health Service Human Research Ethics Committee (HREC/74678/MonH-2021-269029), Monash (protocol V6, 25 June 2023).

Individual outcome data will be summarised and provided to participating carers and practitioners to enhance care. Group-level findings will be presented at a local workshop to engage stakeholders. Findings will be presented at national and international conferences and published in peer-reviewed journals. All results will be reported so that they can be used to inform prior information for future trials.

Trial registration number

NCT04968522.

☐ ☆ ✇ BMJ Open

Linking genetic counseling communication skills to patient outcomes and experiences using a community-engagement and provider-engagement approach: research protocol for the GC-PRO mixed methods sequential explanatory study

Por: Fisher · E. R. · Cragun · D. · Dedrick · R. F. · Lumpkins · C. Y. · Ramirez · M. · Kaphingst · K. A. · Petersen · A. · MacFarlane · I. M. · Redlinger-Grosse · K. · Shire · A. · Culhane-Pera · K. A. · Zierhut · H. A. — Abril 17th 2024 at 17:18
Introduction

In over 50 years since the genetic counseling (GC) profession began, a systematic study of GC communication skills and patient-reported outcomes in actual sessions across multiple clinical specialties has never been conducted. To optimize GC quality and improve efficiency of care, the field must first be able to comprehensively measure GC skills and determine which skills are most critical to achieving positive patient experiences and outcomes. This study aims to characterise GC communication skills using a novel and pragmatic measure and link variations in communication skills to patient-reported outcomes, across clinical specialties and with patients from diverse backgrounds in the USA. Our community-engagement and provider-engagement approach is crucial to develop recommendations for quality, culturally informed GC care, which are greatly needed to improve GC practice.

Methods and analysis

A mixed methods, sequential explanatory design will be used to collect and analyze: audio-recorded GC sessions in cancer, cardiac, and prenatal/reproductive genetic indications; pre-visit and post-visit quantitative surveys capturing patient experiences and outcomes and post-visit qualitative interview data. A novel, practical checklist will measure GC communication skills. Coincidence analysis will identify patterns of GC skills that are consistent with high scores on patient-reported measures. Two-level, multilevel models will be used to evaluate how GC communication skills and other session/patient characteristics predict patient-reported outcomes. Four community advisory boards (CABs) and a genetic counselor advisory board will inform the study design and analysis.

Ethics and dissemination

This study has been approved by the single Institutional Review Board of the University of Minnesota. This research poses no greater than minimal risk to participants. Results from this study will be shared through national and international conferences and through community-based dissemination as guided by the study’s CABs. A lay summary will also be disseminated to all participants.

☐ ☆ ✇ BMJ Open

Professionals perspectives on interventions to reduce problematic alcohol use in older adults: a realist evaluation of working elements

Por: van den Bulck · F. A. E. · Knijff · R. · Crutzen · R. · van de Mheen · D. · Bovens · R. H. L. M. · Stutterheim · S. E. · Van de Goor · I. · Rozema · A. D. — Abril 16th 2024 at 08:27
Objectives

This study set out to understand how (which elements), in what context and why (which mechanisms) interventions are successful in reducing (problematic) alcohol use among older adults, from the perspective of professionals providing these interventions.

Design

Guided by a realist evaluation approach, an existing initial programme theory (IPT) on working elements in alcohol interventions was evaluated by conducting semistructured interviews with professionals.

Setting and participants

These professionals (N=20) provide interventions across several contexts: with or without practitioner involvement; in-person or not and in an individual or group setting. Data were coded and links between contexts, elements, mechanisms and outcomes were sought for to confirm, refute or refine the IPT.

Results

From the perspective of professionals, there are several general working elements in interventions for older adults: (1) pointing out risks and consequences of drinking behaviour; (2) paying attention to abstinence; (3) promoting contact with peers; (4) providing personalised content and (5) providing support. We also found context-specific working elements: (1) providing personalised conversations and motivational interviewing with practitioners; (2) ensuring safety, trust and a sense of connection and a location nearby home or a location that people are familiar with in person and (3) sharing experiences and tips in group interventions. Furthermore, the mechanisms awareness and accessible and low threshold participation were important contributors to positive intervention outcomes.

Conclusion

In addition to the IPT, our findings emphasise the need for social contact and support, personalised content, and strong relationships (both between client and practitioner, and client and peers) in interventions for older adults.

☐ ☆ ✇ BMJ Open

How do people living with obesity who use obesity services perceive healthcare professionals representation of the disease on social media? An interpretative phenomenological analysis

Por: Maher · S. · McHugh · J. · Crotty · M. · Birney · S. · OConnell · J. · Finucane · F. · Spooner · M. — Abril 16th 2024 at 08:27
Objectives

The objective of this study was to explore how people living with obesity who use obesity services perceive healthcare professionals’ (HCPs) online representation of the disease on social media. By exploring their perspective, we aimed to develop a framework to inform good practice around social media use for HCPs.

Design

This was a qualitative study using a phenomenological framework. Following in-depth semi-structured interviews, analysis was undertaken to identify superordinate themes relating to how HCPs portray living with obesity online.

Setting

Patient advocacy organisation (The Irish Coalition for People Living with Obesity) and three clinical sites offering obesity treatment in Ireland.

Participants

15 adult participants comprising of 12 women and 3 men who use social media and are living with obesity and who use obesity services.

Results

Three key themes of how people living with obesity who use obesity services perceive HCP’s online representation of the disease. (1) Negative experiences of HCPs—participants describe encountering weight stigma and bias on social media from HCPs that they characterised as simplistic and outdated conceptualisations. These engender shame, fear and anger. (2) Positive experience of HCPs—participants report social media allows HCPs to educate and inform public perception of obesity. Positive online experiences lead to feelings of inclusion, understanding and encouragement. (3) Expectations of HCPs—qualifications, professional titles and academic association affected the perceived trustworthiness of information and its impact on readers. Participants feel there is a duty of care for HCPs in obesity medicine to advocate and be active online to provide accurate medical information.

Conclusion

HCP’s use of social media has a powerful impact on people with obesity who use healthcare and obesity services. Social media is a key tool in obesity awareness and education. We propose the ‘3E’ framework—Empower, Evidence-Based and Educate and be educated to guide HCPs’ social media use.

☐ ☆ ✇ BMJ Open

Operational complexities in international clinical trials: a systematic review of challenges and proposed solutions

Por: Gumber · L. · Agbeleye · O. · Inskip · A. · Fairbairn · R. · Still · M. · Ouma · L. · Lozano-Kuehne · J. · Bardgett · M. · Isaacs · J. D. · Wason · J. M. · Craig · D. · Pratt · A. G. — Abril 16th 2024 at 08:27
Objective

International trials can be challenging to operationalise due to incompatibilities between country-specific policies and infrastructures. The aim of this systematic review was to identify the operational complexities of conducting international trials and identify potential solutions for overcoming them.

Design

Systematic review.

Data sources

Medline, Embase and Health Management Information Consortium were searched from 2006 to 30 January 2023.

Eligibility criteria

All studies reporting operational challenges (eg, site selection, trial management, intervention management, data management) of conducting international trials were included.

Data extraction and synthesis

Search results were independently screened by at least two reviewers and data were extracted into a proforma.

Results

38 studies (35 RCTs, 2 reports and 1 qualitative study) fulfilled the inclusion criteria. The median sample size was 1202 (IQR 332–4056) and median number of sites was 40 (IQR 13–78). 88.6% of studies had an academic sponsor and 80% were funded through government sources. Operational complexities were particularly reported during trial set-up due to lack of harmonisation in regulatory approvals and in relation to sponsorship structure, with associated budgetary impacts. Additional challenges included site selection, staff training, lengthy contract negotiations, site monitoring, communication, trial oversight, recruitment, data management, drug procurement and distribution, pharmacy involvement and biospecimen processing and transport.

Conclusions

International collaborative trials are valuable in cases where recruitment may be difficult, diversifying participation and applicability. However, multiple operational and regulatory challenges are encountered when implementing a trial in multiple countries. Careful planning and communication between trials units and investigators, with an emphasis on establishing adequately resourced cross-border sponsorship structures and regulatory approvals, may help to overcome these barriers and realise the benefits of the approach.

Open science framework registration number

osf-registrations-yvtjb-v1.

☐ ☆ ✇ International Wound Journal

The role of orthobiologics in chronic wound healing

Abstract

Chronic wounds, characterized by prolonged healing processes, pose a significant medical challenge with multifaceted aetiologies, including local and systemic factors. Here, it explores the complex pathogenesis of chronic wounds, emphasizing the disruption in the normal phases of wound healing, particularly the inflammatory phase, leading to an imbalance in extracellular matrix (ECM) dynamics and persistent inflammation. Senescent cell populations further contribute to impaired wound healing in chronic lesions. Traditional medical management focuses on addressing underlying causes, but many chronic wounds resist to conventional treatments, necessitating innovative approaches. Recent attention has turned to autologous orthobiologics, such as platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and mesenchymal stem cells (MSCs), as potential regenerative interventions. These biologically derived materials, including bone marrow aspirate/concentrate (BMA/BMAC) and adipose tissue-derived stem cells (ADSCs), exhibit promising cytokine content and regenerative potential. MSCs, in particular, have emerged as key players in wound healing, influencing inflammation and promoting tissue regeneration. This paper reviews relevant scientific literature regarding basic science and brings real-world evidence regarding the use of orthobiologics in the treatment of chronic wounds, irrespective of aetiology. The discussion highlights the regenerative properties of PRP, PRF, BMA, BMAC and SVF, showcasing their potential to enhance wound healing. Despite advancements, further research is essential to elucidate the specific roles of each orthobiologic and determine optimal applications for different wound types. The conclusion underscores the evolving landscape in chronic wound management, with a call for more comprehensive studies to refine treatment strategies and maximize the benefits of regenerative medicine.

☐ ☆ ✇ PLOS ONE Medicine&Health

Specific nanoprobe design for MRI: Targeting laminin in the blood-brain barrier to follow alteration due to neuroinflammation

by Juan F. Zapata-Acevedo, Mónica Losada-Barragán, Johann F. Osma, Juan C. Cruz, Andreas Reiber, Klaus G. Petry, Amael Caillard, Audrey Sauldubois, Daniel Llamosa Pérez, Aníbal José Morillo Zárate, Sonia Bermúdez Muñoz, Agustín Daza Moreno, Rafaela V. Silva, Carmen Infante-Duarte, William Chamorro-Coral, Rodrigo E. González-Reyes, Karina Vargas-Sánchez

Chronic neuroinflammation is characterized by increased blood-brain barrier (BBB) permeability, leading to molecular changes in the central nervous system that can be explored with biomarkers of active neuroinflammatory processes. Magnetic resonance imaging (MRI) has contributed to detecting lesions and permeability of the BBB. Ultra-small superparamagnetic particles of iron oxide (USPIO) are used as contrast agents to improve MRI observations. Therefore, we validate the interaction of peptide-88 with laminin, vectorized on USPIO, to explore BBB molecular alterations occurring during neuroinflammation as a potential tool for use in MRI. The specific labeling of NPS-P88 was verified in endothelial cells (hCMEC/D3) and astrocytes (T98G) under inflammation induced by interleukin 1β (IL-1β) for 3 and 24 hours. IL-1β for 3 hours in hCMEC/D3 cells increased their co-localization with NPS-P88, compared with controls. At 24 hours, no significant differences were observed between groups. In T98G cells, NPS-P88 showed similar nonspecific labeling among treatments. These results indicate that NPS-P88 has a higher affinity towards brain endothelial cells than astrocytes under inflammation. This affinity decreases over time with reduced laminin expression. In vivo results suggest that following a 30-minute post-injection, there is an increased presence of NPS-P88 in the blood and brain, diminishing over time. Lastly, EAE animals displayed a significant accumulation of NPS-P88 in MRI, primarily in the cortex, attributed to inflammation and disruption of the BBB. Altogether, these results revealed NPS-P88 as a biomarker to evaluate changes in the BBB due to neuroinflammation by MRI in biological models targeting laminin.
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