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Finerenone cardiovascular and kidney outcomes by age and sex: FIDELITY post hoc analysis of two phase 3, multicentre, double-blind trials

Por: Bansal · S. · Canziani · M. E. F. · Birne · R. · Anker · S. D. · Bakris · G. L. · Filippatos · G. · Rossing · P. · Ruilope · L. M. · Farjat · A. E. · Kolkhof · P. · Lage · A. · Brinker · M. · Pitt · B.
Objectives

This study aimed to evaluate the efficacy and safety of finerenone, a selective, non-steroidal mineralocorticoid receptor antagonist, on cardiovascular and kidney outcomes by age and/or sex.

Design

FIDELITY post hoc analysis; median follow-up of 3 years.

Setting

FIDELITY: a prespecified analysis of the FIDELIO-DKD and FIGARO-DKD trials.

Participants

Adults with type 2 diabetes and chronic kidney disease receiving optimised renin–angiotensin system inhibitors (N=13 026).

Interventions

Randomised 1:1; finerenone or placebo.

Primary and secondary outcome measures

Cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure (HHF)) and kidney (kidney failure, sustained ≥57% estimated glomerular filtration rate (eGFR) decline or renal death) composite outcomes.

Results

Mean age was 64.8 years; 45.2%, 40.1% and 14.7% were aged interaction=0.42) and sex categories (HR 0.86 (95% CI 0.77 to 0.96) (male), HR 0.89 (95% CI 0.35 to 2.27) (premenopausal female), HR 0.87 (95% CI 0.73 to 1.05) (postmenopausal female); Pinteraction=0.99). Effects on HHF reduction were not modified by age (Pinteraction=0.70) but appeared more pronounced in males (Pinteraction=0.02). Kidney events were reduced with finerenone versus placebo in age groups interaction=0.51). In sex subgroups, finerenone consistently reduced kidney events (Pinteraction=0.85). Finerenone reduced albuminuria and eGFR decline regardless of age and sex. Hyperkalaemia increased with finerenone, but discontinuation rates were

Conclusions

Finerenone improved cardiovascular and kidney composite outcomes with no significant heterogeneity between age and sex subgroups; however, the effect on HHF appeared more pronounced in males. Finerenone demonstrated a similar safety profile across age and sex subgroups.

Trial registration numbers

NCT02540993, NCT02545049.

Talking in primary care (TIP): protocol for a cluster-randomised controlled trial in UK primary care to assess clinical and cost-effectiveness of communication skills e-learning for practitioners on patients musculoskeletal pain and enablement

Por: Bishop · F. L. · Cross · N. · Dewar-Haggart · R. · Teasdale · E. · Herbert · A. · Robinson · M. E. · Ridd · M. J. · Mallen · C. · Clarson · L. · Bostock · J. · Becque · T. · Stuart · B. · Garfield · K. · Morrison · L. · Pollet · S. · Vennik · J. · Atherton · H. · Howick · J. · Leydon · G. M
Introduction

Effective communication can help optimise healthcare interactions and patient outcomes. However, few interventions have been tested clinically, subjected to cost-effectiveness analysis or are sufficiently brief and well-described for implementation in primary care. This paper presents the protocol for determining the effectiveness and cost-effectiveness of a rigorously developed brief eLearning tool, EMPathicO, among patients with and without musculoskeletal pain.

Methods and analysis

A cluster randomised controlled trial in general practitioner (GP) surgeries in England and Wales serving patients from diverse geographic, socioeconomic and ethnic backgrounds. GP surgeries are randomised (1:1) to receive EMPathicO e-learning immediately, or at trial end. Eligible practitioners (eg, GPs, physiotherapists and nurse practitioners) are involved in managing primary care patients with musculoskeletal pain. Patient recruitment is managed by practice staff and researchers. Target recruitment is 840 adults with and 840 without musculoskeletal pain consulting face-to-face, by telephone or video. Patients complete web-based questionnaires at preconsultation baseline, 1 week and 1, 3 and 6 months later. There are two patient-reported primary outcomes: pain intensity and patient enablement. Cost-effectiveness is considered from the National Health Service and societal perspectives. Secondary and process measures include practitioner patterns of use of EMPathicO, practitioner-reported self-efficacy and intentions, patient-reported symptom severity, quality of life, satisfaction, perceptions of practitioner empathy and optimism, treatment expectancies, anxiety, depression and continuity of care. Purposive subsamples of patients, practitioners and practice staff take part in up to two qualitative, semistructured interviews.

Ethics approval and dissemination

Approved by the South Central Hampshire B Research Ethics Committee on 1 July 2022 and the Health Research Authority and Health and Care Research Wales on 6 July 2022 (REC reference 22/SC/0145; IRAS project ID 312208). Results will be disseminated via peer-reviewed academic publications, conference presentations and patient and practitioner outlets. If successful, EMPathicO could quickly be made available at a low cost to primary care practices across the country.

Trial registration number

ISRCTN18010240.

Protocol for the process evaluation of an intervention to improve antenatal smoking cessation support (MOHMQuit) in maternity services in New South Wales, Australia

Por: Longman · J. · Paul · C. · Cashmore · A. · Twyman · L. · Barnes · L. A. J. · Adams · C. · Bonevski · B. · Milat · A. · Passey · M. E.
Introduction

Smoking cessation in pregnancy remains a public health priority. Our team used the Behaviour Change Wheel to develop the Midwives and Obstetricians Helping Mothers to Quit smoking (MOHMQuit) intervention with health system, leader (including managers and educators) and clinician components. MOHMQuit addresses a critical evidence to practice gap in the provision of smoking cessation support in antenatal care. It involves nine maternity services in New South Wales in a cluster randomised stepped-wedge controlled trial of effectiveness. This paper describes the design and rationale for the process evaluation of MOHMQuit. The process evaluation aims to assess to what extent and how MOHMQuit is being implemented (acceptability; adoption/uptake; appropriateness; feasibility; fidelity; penetration and sustainability), and the context in which it is implemented, in order to support further refinement of MOHMQuit throughout the trial, and aid understanding and interpretation of the results of the trial.

Methods and analysis

The process evaluation is an integral part of the stepped-wedge trial. Its design is underpinned by implementation science frameworks and adopts a mixed methods approach. Quantitative evidence from participating leaders and clinicians in our study will be used to produce individual and site-level descriptive statistics. Qualitative evidence of leaders’ perceptions about the implementation will be collected using semistructured interviews and will be analysed descriptively within-site and thematically across the dataset. The process evaluation will also use publicly available data and observations from the research team implementing MOHMQuit, for example, training logs. These data will be synthesised to provide site-level as well as individual-level implementation outcomes.

Ethics and dissemination

The study received ethical approval from the Population Health Services Research Ethics Committee for NSW, Australia (Reference 2021/ETH00887). Results will be communicated via the study’s steering committee and will also be published in peer-reviewed journals and presented at conferences.

Trial registration number

Australian New Zealand Trials Registry ACTRN12622000167763. https://www.australianclinicaltrials.gov.au/anzctr/trial/ACTRN12622000167763.

Exploration of Latina/Hispanic womens experiences living with non-alcoholic fatty liver disease: a qualitative study with patients in Houston

Por: Heredia · N. I. · Mendoza Duque · E. · Ayieko · S. · Averyt · A. · McNeill · L. H. · Hwang · J. P. · Fernandez · M. E.
Objectives

A deeper understanding of the lived experiences of Hispanic patients with non-alcoholic fatty liver disease (NAFLD) can help guide the development of behavioural programmes that facilitate NAFLD management. This paper explores Hispanic women’s experiences living with NAFLD.

Design, setting, participants

We collected brief sociodemographic questionnaires and conducted in-depth interviews with 12 low-income (all had household income ≤USD$55 000 per year) Hispanic women with NAFLD from the Houston area. Transcripts were audio-recorded and transcribed. We developed a coding scheme and used thematic analysis to identify emergent themes, supported by Atlas.ti.

Results

Participants identified physicians as their main information source on NAFLD but also consulted the internet, family, friends and peers. Many were still left wanting more information. Participants identified family history, sedentary lifestyles, poor diet and comorbid conditions as causes for their NAFLD. Participants also reported emotional distress after diagnosis. Participants experienced both successes and challenges in making lifestyle changes in nutrition and physical activity. Some participants received desired social support in managing NAFLD, although there were conflicting feelings about spousal support.

Conclusion

Multifaceted programming that improves patient–provider communication, conveys accurate information and enhances social support is needed to support Hispanic women in managing NAFLD.

DEcreased Cognitive functiON, NEurovascular CorrelaTes and myocardial changes in women with a history of pre-eclampsia (DECONNECT): research protocol for a cross-sectional pilot study

Por: Brandt · Y. · Alers · R.-J. · Canjels · L. P. W. · Jorissen · L. M. · Jansen · G. · Janssen · E. B. N. J. · van Kuijk · S. M. · Went · T. M. · Koehn · D. · Gerretsen · S. C. · Jansen · J. F. · Backes · W. H. · Hurks · P. P. M. · van de Ven · V. · Kooi · M. E. · Spaanderman · M. E. A.
Introduction

Pre-eclampsia is a hypertensive disorder affecting up to 8% of pregnancies. After pre-eclampsia, women are at increased risk of cognitive problems, and cerebrovascular and cardiovascular disorders. These sequelae could result from microvascular dysfunction persisting after pre-eclampsia. This study will explore differences in cerebral and myocardial microvascular function between women after pre-eclampsia and women after normotensive gestation. We hypothesise that pre-eclampsia alters cerebral and myocardial microvascular functions, which in turn are related to diminished cognitive and cardiac performance.

Methods and analysis

The cross-sectional ‘DEcreased Cognitive functiON, NEurovascular CorrelaTes and myocardial changes in women with a history of pre-eclampsia’ (DECONNECT) pilot study includes women after pre-eclampsia and controls after normotensive pregnancy between 6 months and 20 years after gestation. We recruit women from the Queen of Hearts study, a study investigating subclinical heart failure after pre-eclampsia. Neuropsychological tests are employed to assess different cognitive domains, including attention, processing speed, and cognitive control. Cerebral images are recorded using a 7 Tesla MRI to assess blood–brain barrier integrity, perfusion, blood flow, functional and structural networks, and anatomical dimensions. Cardiac images are recorded using a 3 Tesla MRI to assess cardiac perfusion, strain, dimensions, mass, and degree of fibrosis. We assess the effect of a history of pre-eclampsia using multivariable regression analyses.

Ethics and dissemination

This study is approved by the Ethics Committee of Maastricht University Medical Centre (METC azM/UM, NL47252.068.14). Knowledge dissemination will include scientific publications, presentations at conferences and public forums, and social media.

Trial registration number

NCT02347540.

Assessing trends and variability in outpatient dual testing for chronic kidney disease with urine albumin and serum creatinine, 2009-2018: a retrospective cohort study in the Veterans Health Administration System

Por: Bhave · N. M. · Han · Y. · Steffick · D. · Bragg-Gresham · J. · Zivin · K. · Burrows · N. R. · Pavkov · M. E. · Tuot · D. · Powe · N. R. · Saran · R.
Background

Simultaneous urine testing for albumin (UAlb) and serum creatinine (SCr), that is, ‘dual testing,’ is an accepted quality measure in the management of diabetes. As chronic kidney disease (CKD) is defined by both UAlb and SCr testing, this approach could be more widely adopted in kidney care.

Objective

We assessed time trends and facility-level variation in the performance of outpatient dual testing in the integrated Veterans Health Administration (VHA) system.

Design, subjects and main measures

This retrospective cohort study included patients with any inpatient or outpatient visit to the VHA system during the period 2009–2018. Dual testing was defined as UAlb and SCr testing in the outpatient setting within a calendar year. We assessed time trends in dual testing by demographics, comorbidities, high-risk (eg, diabetes) specialty care and facilities. A generalised linear mixed-effects model was applied to explore individual and facility-level predictors of receiving dual testing.

Key results

We analysed data from approximately 6.9 million veterans per year. Dual testing increased, on average, from 17.4% to 21.2%, but varied substantially among VHA centres (0.3%–43.7% in 2018). Dual testing was strongly associated with diabetes (OR 10.4, 95% CI 10.3 to 10.5, p

Conclusions

Dual testing for CKD in high-risk specialties is increasing but remains low. This appears primarily due to low rates of testing for albuminuria. Promoting dual testing in high-risk patients will help to improve disease management and patient outcomes.

Personal strategies to reduce the effects of landscape fire smoke on asthma-related outcomes: a protocol for systematic review and meta-analysis

Por: Beyene · T. · Gibson · P. G. · Murphy · V. · Jensen · M. E. · McDonald · V. M.
Introduction

Landscape fire smoke (LFS) contains several hazardous air pollutants that are known to be detrimental to human health. People with asthma are more vulnerable to the health impact of LFS than general populations. The aim of this review is to investigate the effectiveness of personal strategies to reduce the effect of LFS on asthma-related outcomes.

Methods and analysis

We will electronically search databases such as Medline, Embase, CINAHL and Cochrane Clinical Trials Register to identify eligible articles for the review. Screening of search results and data extraction from included studies will be completed by two independent reviewers. The risk of bias (RoB 2) will be assessed using the Risk of Bias Assessment Tool for Non-Randomised Studies for observational studies, the Cochrane Collaboration tool for assessing the RoB 2 for randomised controlled trials (RCTs) and the Risk Of Bias In Nonrandomized Studies of Interventions tool for non-RCTs. A random-effect meta-analysis will be performed to determine the pooled summary of findings of the included studies. If meta-analysis is not possible, we will conduct a narrative synthesis. Findings will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement.

Ethics and dissemination

This study will synthesise the available evidence obtained from published studies and as such, no ethical approval is required. The review will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD42022341120.

Is reduced heart rate variability associated with functional somatic disorders? A cross-sectional population-based study; DanFunD

Por: Jorgensen · T. · Dantoft · T. M. · Petersen · M. W. · Gormsen · L. · Winter-Jensen · M. · Fink · P. · Linneberg · A. · Benros · M. E. · Eplov · L. F. · Bjerregaard · A. A. · Schovsbo · S. U. · Brinth · L. S.
Objectives

It has been hypothesised that functional somatic disorders (FSD) could be initiated by sympathetic predominance in the autonomic nervous system as measured by low heart rate variability (HRV). Earlier studies on the association between HRV and FSD are small case–control studies hampered by selection bias and do not consider the great overlap between the various FSDs. The aim of the present study is to assess any associations between HRV and various FSDs and whether chronic stress confounds such an association.

Design

A cross-sectional general population-based study.

Setting

The Danish Study of Functional Somatic Disorders conducted 2013–2015 in 10 municipalities in the western part of Greater Copenhagen, Denmark.

Participants

A total of 6891 men and women aged 18–72 years were included in the analyses after exclusion of 602 persons with missing HRV data. Various delimitations of FSD (chronic fatigue, chronic widespread pain, irritable bowel and bodily distress syndrome) were identified by validated questionnaires and diagnostic interviews. HRV parameters in time and frequency domains were calculated from successive beat-to-beat heart rate (HR) data using the ‘E-motion’ HR monitor device during 7 min of supine rest. Chronic stress was assessed by Cohen’s self-perceived stress scale.

Outcome measures

Logistic regression analyses were used to calculate possible associations between the various delimitations of FSD and HRV adjusting for chronic stress.

Results

Persons with FSD had a slightly higher mean HR and lower HRV as measured by time domain parameters, whereas associations with frequency domain parameters were not consistent. Adjusting for chronic stress attenuated associations slightly.

Conclusion

The study supports a sympathetic predominance in persons with FSD, which could not be entirely explained by chronic stress. However, it is not possible to conclude whether the association is a causal factor to or a consequence of FSD.

Scope, range and effectiveness of interventions to address social norms to prevent and delay child marriage and empower adolescent girls: a systematic review

Por: Greene · M. E. · Edmeades · J. · Siddiqi · M.
Objectives

Harmful gender and social norms prescribe divergent opportunities for girls and boys and drive child marriage. This systematic review examines the scope, range and effectiveness of interventions to change social norms and delay child marriage.

Design

We systematically assess the contributions made by interventions that work to shift norms to prevent child marriage or to limit its harmful consequences. Our analysis classifies each study’s quality in evaluation and implementation design regarding shifting norms.

Data sources

We conducted a search of electronic databases (PubMed, PsycINFO, Embase, CINAHL Plus, Popline, Web of Science and Cochrane Library) and grey literature (targeted hand-searches of 15 key organisations and Google Scholar).

Eligibility criteria

Included interventions sought to change norms related to child marriage, were evaluated in experimental or quasi-experimental evaluations, collected data on age at marriage and norms/attitudes, and were published in English from January 2000 to September 2021.

Data extraction and synthesis

We used a standardised form to extract data from all eligible studies, and double-screened to validate coding and reporting. We classified the studies by low, medium and high quality for evaluation and risk of bias, and separately by the extent to which they addressed social norms.

Results

Our assessment of the 12 eligible studies identified revealed little evidence of a systematic relationship between social norms related to marriage and changes in child marriage behaviours. We found stronger evidence of programme effect on child marriage outcomes than on social norms, though only a minority of studies found an effect for either. Studies that appeared effective in changing child marriage norms varied greatly in scale and extent of programming, and few attempted to identify the appropriate reference groups for measuring social norms.

Conclusion

The studies evaluated by our review provide only weak evidence on the impact of interventions on norms, and on the link between shifts in norms and marriage behaviour.

Language Access Systems Improvement initiative: impact on professional interpreter utilisation, a natural experiment

Por: Karliner · L. S. · Gregorich · S. E. · Mutha · S. · Kaplan · C. · Livaudais-Toman · J. · Pathak · S. · Garcia · M. E. · Diamond · L.
Objectives

This study aims to evaluate the Language Access Systems Improvement (LASI) initiative’s impact on professional interpreter utilisation in primary care and to explore patient and clinician perspectives on professional interpreter use.

Design

Multi methods: Quantitative natural experiment pre-LASI and post-LASI, qualitative semistructured interviews with clinicians and focus groups with patients post-LASI.

Setting

Large, academic primary care practice.

Participants

Cantonese, Mandarin, Spanish, English-speaking adult patients and their clinicians.

Intervention

LASI initiative: Implementation of a clinician language proficiency test and simultaneous provision of on-demand access to professional interpreters via video medical interpretation.

Main outcome measures

Quantitative: Proportion of language discordant primary care visits which were professionally interpreted. Qualitative: Salient themes related to professional interpreter use and non-use.

Results

The researchers categorised language concordance for 1475 visits with 152 unique clinicians; 698 were not fully language concordant (202 pre-LASI and 496 post-LASI). Professional interpreter utilisation increased (pre-LASI 57% vs post-LASI 66%; p=0.01); the visits with the lowest percentage of profssional interpreter use post-LASI were those in which clinicians and patients had partial language concordance. In inverse probability weighted analysis, restricting to 499 visits with strict estimated propensity score overlap (100% common support), post-LASI visits had higher odds of using a professional interpreter compared with pre-LASI visits (OR 2.39; 95% CI 1.04 to 5.48). Qualitative results demonstrate video interpretation was convenient and well liked by both clinicians and patients. Some partially bilingual clinicians reported frustration with patient refusal of interpreter services; others reported using the video interpreters as a backup during visits. Views of the care-partner role differed for clinicians and patients. Clinicians reported sometimes having family interpret out of convenience or habit, whereas patients reported wanting family members present for support and advocacy, not interpretation.

Conclusions

LASI increased utilisation of professional interpreters; however, this was least prominent for partially language concordant visits. Health systems wishing to implement LASI or similar interventions will need to support clinicians and patients with partial bilingual skills in their efforts to use professional interpreters.

Trial registration number

HSRP20153367.

Correlational study of ergonomic knowledge and level of MSK discomfort during online classes of 1st-4th year UST-CRS physical therapy students: a cross-sectional study

Por: Siy · W. · Sicat · Z. M. · Bautista · T. M. · Formalejo · A. · Gatdula · M. E. · Ico · A. A. · Julian · C. J. · Pabion · M. C. · Reyes · J. L. · Santander · N. M.
Introduction

The abrupt transition of the mode of learning due to the COVID-19 pandemic resulted in an increase in complaints of musculoskeletal (MSK) discomfort among students in Higher Education Institutions (HEI). Inadequate physical space and equipment are one major cause of these complaints. Among HEIs, physical therapy (PT) students have sufficient background in managing MSK discomforts. However, this does not prevent them from experiencing pain and discomfort during online classes. This analytical cross-sectional study aims to determine the correlation between ergonomic knowledge and MSK discomfort among first-year to fourth-year PT students.

Methods and analysis

The study will use two questionnaires, the Ergonomic Knowledge Questionnaire, and the Cornell Musculoskeletal Discomfort Questionnaire, that determine the level of ergonomic knowledge and MSK discomfort, respectively. This will be disseminated to 144 students through google forms. Results will then be analysed using Pearson Correlation Test. The study anticipates a correlation between the level of ergonomic knowledge and MSK discomfort among the participants.

Ethics and dissemination

The study has been approved by the University of Santo Tomas-College of Rehabilitation Sciences Ethics Review Committee. The participants will receive the results prior to publication in a peer-reviewed scientific journal.

Trial registration number

Philippine Health Research Registry with registry ID PHRR230216-005443.

Medical students impacted by discrimination: a qualitative study into their experiences of belonging and support systems at medical schools in the UK

Por: Ikhlaq · H. · Agarwal · S. · Kwok · C. · Golamgouse · H. · Derby · S. · McRae · N. · Brown · M. E. L. · Collin · V. · Parekh · R. · Kumar · S.
Objective

To better understand the broader experience of medical students impacted by discrimination and the support systems they engage with.

Design

Qualitative study using semi-structured interviews.

Setting

Four medical schools based in the UK.

Participants

17 medical students were recruited using volunteer and snowball sampling: all students self-identified as being impacted by discrimination.

Results

5 themes were identified: feelings of isolation, imposter syndrome and exclusion; a lack of representation and positive role modelling; the importance of peer support; issues relating to the accessibility of support; building support networks through shared experiences and attempts to foster a sense of inclusion through peer and institutionally led initiatives.

Conclusions

The findings of this study suggest medical schools could do more to recognise the importance of acknowledging the multiple identities at risk of discrimination held by students, perpetuating feelings of isolation and exclusion. Our research highlights the need for practical systemic initiatives to improve the sense of belonging of medical students who are impacted by discrimination. Medical educators and institutions should consider formal and informal provisions, such as creating time and space for students to meet and share experiences, access support and reporting networks, to foster a greater sense of belonging.

What are the determinants of variation in caretaker satisfaction with sick child consultations? A cross-sectional analysis in five low-income and middle-income countries

Por: Turcotte-Tremblay · A.-M. · Lee · H.-Y. · Kruk · M. E.
Objectives

The objective of this study was to explore determinants of variation in overall caretaker satisfaction with curative care for sick children under the age of 5 in five low-income and middle-income countries.

Design

A pooled cross-sectional analysis was conducted using data from the Service Provision Assessment.

Setting

We used data collected in five countries (Afghanistan, Democratic Republic of the Congo, Haiti, Malawi and Tanzania) between 2013 and 2018.

Participants

Respondents were 13 149 caretakers of children under the age of 5 who consulted for a sick child visit.

Primary outcomes measured

The outcome variable was whether the child’s caretaker was very satisfied versus more or less satisfied or not satisfied overall. Predictors pertained to child and caretaker characteristics, health system foundations and process of care (eg, care competence, user experience). Two-level logistic regression models were used to assess the extent to which these categories of variables explained variation in satisfaction. The main analyses used pooled data; country-level analyses were also performed.

Results

Process of care, including user experience, explained the largest proportion of variance in caretaker satisfaction (13.8%), compared with child and caretaker characteristics (0.9%) and health system foundations (3.8%). The odds of being very satisfied were lower for caretakers who were not given adequate explanation (OR: 0.56, 95% CI 0.46 to 0.67), who had a problem with medication availability (OR: 0.31, 95% CI 0.27 to 0.35) or who encountered a problem with the cost of services (OR: 0.57, 95% CI 0.48 to 0.66). The final model explained only 21.8% of the total variance. Country-level analyses showed differences in variance explained and in associations with predictors.

Conclusions

Better process of care, especially user experience, should be prioritised for its benefit regarding caretaker satisfaction. Unmeasured factors explained the majority of variation in caretaker satisfaction and should be explored in future studies.

Suppression of pathogens in properly refrigerated raw milk

by M. E. Coleman, T. P. Oscar, T. L. Negley, M. M. Stephenson

Conflicting claims exist regarding pathogen growth in raw milk. A small pilot study was designed to provide definitive data on trends for pathogen growth and decline in raw bovine milk hygienically produced for direct human consumption. An independent laboratory conducted the study, monitoring growth and decline of pathogens inoculated into raw milk. Raw milk samples were inoculated with foodborne pathogens (Campylobacter, E. coli O157:H7, Listeria monocytogenes, or Salmonella) at lower (L. monocytogenes in 8 of 12 replicates (P = 0.001 to P = 0.028). Analysis of variance confirmed significant increases for L. monocytogenes at both initial levels in week 2. No evidence of growth was documented over 14 days for the three pathogens predominantly associated with raw milk outbreaks in the US (Campylobacter, E. coli O157:H7, and Salmonella). Further research is needed to characterize parameters for pathogen growth and decline to support re-assessment of risks that were based on incorrect assumptions about interactions of pathogens with the raw milk microbiota.

Mapping Oral health and Local Area Resources (MOLAR): protocol for a randomised controlled trial connecting emergency department patients with social and dental resources

Por: Simon · L. · Marsh · R. · Sanchez · L. D. · Camargo · C. · Donoff · B. · Cardenas · V. · Manning · W. · Loo · S. · Cash · R. E. · Samuels-Kalow · M. E.
Introduction

There are substantial inequities in oral health access and outcomes in the USA, including by income and racial and ethnic identity. People with adverse social determinants of health (aSDoH), such as housing or food insecurity, are also more likely to have unmet dental needs. Many patients with dental problems present to the emergency department (ED), where minimal dental care or referral is usually available. Nonetheless, the ED represents an important point of contact to facilitate screening and referral for unmet oral health needs and aSDoH, particularly for patients who may not otherwise have access to care.

Methods and analysis

Mapping Oral health and Local Area Resources is a randomised controlled trial enrolling 2049 adult and paediatric ED patients with unmet oral health needs into one of three trial arms: (a) a standard handout of nearby dental and aSDoH resources; (b) a geographically matched listing of aSDoH resources and a search link for identification of geographically matched dental resources; or (c) geographically matched resources along with personalised care navigation. Follow-up at 3, 6, 9 and 12 months will evaluate oral health-related quality of life, linkage to resources and dental treatment, ED visits for dental problems and the association between linkage and neighbourhood resource density.

Ethics and dissemination

All sites share a single human subjects review board protocol which has been fully approved by the Mass General Brigham Human Subjects Review Board. Informed consent will be obtained from all adults and adult caregivers, and assent will be obtained from age-appropriate child participants. Results will demonstrate the impact of addressing aSDoH on oral health access and the efficacy of various forms of resource navigation compared with enhanced standard care. Our findings will facilitate sustainable, scalable interventions to identify and address aSDoH in the ED to improve oral health and reduce oral health inequities.

Trial registration number

NCT05688982.

Latin American Cerebral Palsy Register (LATAM-CPR): study protocol to develop a collaborative register with surveillance of children with cerebral palsy in Latin American countries

Por: Ruiz Brunner · M. d. l. M. · Jahan · I. · Cuestas · E. · Cieri · M. E. · Escobar Zuluaga · J. · Condinanzi · A. L. · Sanchez · F. · McIntyre · S. · Smithers-Sheedy · H. · Muhit · M. · Badawi · N. · Diaz · R. · Diaz · A. · Carranza · J. · Duran · C. · Quintero Valencia · C. A. · Melarag
Introduction

Cerebral palsy (CP) is one of the leading causes of childhood disability globally with a high burden in low-income and middle-income countries (LMICs). Preliminary findings from the global LMIC CP Register (GLM CPR) suggest that the majority of CP in LMICs are due to potentially preventable causes. Such data are lacking in the Latin American region. Generating comparable epidemiological data on CP from this region could enable translational research and services towards early diagnosis and early intervention. We aim to establish a Latin American multicountry network and online data repository of CP called Latin American Cerebral Palsy Register (LATAM-CPR).

Methods and analysis

The LATAM-CPR will be modelled after the GLM CPR and will support new and emerging Latin American CP registers following a harmonised protocol adapted from the GLM CPR and piloted in Argentina (ie, Argentine Register of Cerebral Palsy). Both population-based and institution-based surveillance mechanisms will be adopted for registration of children with CP aged less than 18 years to the participating CP registers. The data collection form of the LATAM-CPR will include risk factors, clinical profile, rehabilitation, socioeconomical status of children with CP. Descriptive data on the epidemiology of CP from each participating country will be reported, country-specific and regional data will be compared.

Ethics and dissemination

Individual CP registers have applied ethics approval from respective national human research ethics committees (HREC) and/or institutional review boards prior to the establishment and inclusion into the LATAM-CPR. Ethical approval for LATAM-CPR has already been obtained from the HREC in the two countries that started (Argentina and Mexico). Findings will be disseminated and will be made publicly available through peer-reviewed publications, conference presentations and social media communications.

Does atrial fibrillation affect prognosis in hospitalised COVID-19 patients? A multicentre historical cohort study in the Netherlands

Por: Spruit · J. R. · Jansen · R. W. M. M. · de Groot · J. R. · de Vries · T. A. C. · Hemels · M. E. W. · Douma · R. A. · de Haan · L. R. · Brinkman · K. · Moeniralam · H. S. · de Kruif · M. · Dormans · T. · Appelman · B. · Reidinga · A. C. · Rusch · D. · Gritters van den Oever · N. C.
Objectives

The aim of this multicentre COVID-PREDICT study (a nationwide observational cohort study that aims to better understand clinical course of COVID-19 and to predict which COVID-19 patients should receive which treatment and which type of care) was to determine the association between atrial fibrillation (AF) and mortality, intensive care unit (ICU) admission, complications and discharge destination in hospitalised COVID-19 patients.

Setting

Data from a historical cohort study in eight hospitals (both academic and non-academic) in the Netherlands between January 2020 and July 2021 were used in this study.

Participants

3064 hospitalised COVID-19 patients >18 years old.

Primary and secondary outcome measures

The primary outcome was the incidence of new-onset AF during hospitalisation. Secondary outcomes were the association between new-onset AF (vs prevalent or non-AF) and mortality, ICU admissions, complications and discharge destination, performed by univariable and multivariable logistic regression analyses.

Results

Of the 3064 included patients (60.6% men, median age: 65 years, IQR 55–75 years), 72 (2.3%) patients had prevalent AF and 164 (5.4%) patients developed new-onset AF during hospitalisation. Compared with patients without AF, patients with new-onset AF had a higher incidence of death (adjusted OR (aOR) 1.71, 95% CI 1.17 to 2.59) an ICU admission (aOR 5.45, 95% CI 3.90 to 7.61). Mortality was non-significantly different between patients with prevalent AF and those with new-onset AF (aOR 0.97, 95% CI 0.53 to 1.76). However, new-onset AF was associated with a higher incidence of ICU admission and complications compared with prevalent AF (OR 6.34, 95% CI 2.95 to 13.63, OR 3.04, 95% CI 1.67 to 5.55, respectively).

Conclusion

New-onset AF was associated with an increased incidence of death, ICU admission, complications and a lower chance to be discharged home. These effects were far less pronounced in patients with prevalent AF. Therefore, new-onset AF seems to represent a marker of disease severity, rather than a cause of adverse outcomes.

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.
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.

A qualitative evaluation of the impact of a medical student school outreach project on both medical students and school pupils

Por: Brown · M. E. L. · Ahuja · N. · Sivam · V. · Khanna · A. · Parekh · R.
Objective

To explore medical student and school pupil experiences of an outreach school teaching project.

Setting

Community engagement is increasingly commonplace within medical school. Secondary schools offer ample opportunities for community engagement as medical students teach and engage in service learning. There is a lack of research regarding the impact of school community engagement projects and the impact on pupils, as critical stakeholders in the service medical students provide. In this qualitative study, we explore the perspectives of medical students and school pupils involved in a school teaching project.

Participants

Ten medical students participated in individual interviews, and 17 school pupils across three schools participated in group interviews. Data were analysed using thematic analysis and the concept of service learning.

Results

For medical students, the project fostered communication and teaching skills, but a lack of reflection hampered further benefit. For school pupils, experiences varied – learning about careers in medicine could be inspiring, but content pitched at the incorrect level disengaged some pupils. The conflict between session timing and medical students’ exams negatively influenced engagement.

Conclusions

To shift the focus of community engagement projects that promote service-learning towards mutual benefit, designing in partnership with relevant community stakeholders and integrating opportunities to reflect on these experiences are critical.

Effects of a laboratory-based aerobic exercise intervention on brain volume and cardiovascular health markers: protocol for a randomised clinical trial

Por: Molina Hidalgo · C. · Collins · A. M. · Crisafio · M. E. · Grove · G. · Kamarck · T. W. · Kang · C. · Leckie · R. L. · MacDonald · M. · Manuck · S. B. · Marsland · A. L. · Muldoon · M. F. · Rasero · J. · Scudder · M. R. · Velazquez-Diaz · D. · Verstynen · T. · Wan · L. · Gianaros · P. J
Introduction

Physical activity (PA) has beneficial effects on brain health and cardiovascular disease (CVD) risk. Yet, we know little about whether PA-induced changes to physiological mediators of CVD risk influence brain health and whether benefits to brain health may also explain PA-induced improvements to CVD risk. This study combines neurobiological and peripheral physiological methods in the context of a randomised clinical trial to better understand the links between exercise, brain health and CVD risk.

Methods and analysis

In this 12-month trial, 130 healthy individuals between the ages of 26 and 58 will be randomly assigned to either: (1) moderate-intensity aerobic PA for 150 min/week or (2) a health information control group. Cardiovascular, neuroimaging and PA measurements will occur for both groups before and after the intervention. Primary outcomes include changes in (1) brain structural areas (ie, hippocampal volume); (2) systolic blood pressure (SBP) responses to functional MRI cognitive stressor tasks and (3) heart rate variability. The main secondary outcomes include changes in (1) brain activity, resting state connectivity, cortical thickness and cortical volume; (2) daily life SBP stress reactivity; (3) negative and positive affect; (4) baroreflex sensitivity; (5) pulse wave velocity; (6) endothelial function and (7) daily life positive and negative affect. Our results are expected to have both mechanistic and public health implications regarding brain–body interactions in the context of cardiovascular health.

Ethics and dissemination

Ethical approval has been obtained from the University of Pittsburgh Institutional Review Board (IRB ID: 19020218). This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results Information Submission rule.

Trial registration number

NCT03841669.

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