General Practice and Primary Care - Research Publications

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    A psychological group intervention for high-risk pregnant women: a protocol of a feasibility and acceptability study of the STAR Mums program
    Bellhouse, C ; Komiti, A ; Temple-Smith, M ; Bilardi, J ; Newman, L (ROUTLEDGE JOURNALS, TAYLOR & FRANCIS LTD, 2022-07-04)
    BACKGROUND: In pregnancy, the attachment relationship between a mother and her baby begins to develop and women are more motivated and willing to make changes to become more engaged and responsive mothers and have better relationships with their children. A transgenerational framework has proposed that dysfunctional relationship patterns are often repeated across generations and this has broadened the understanding of early difficulties in parenting. Despite this there has been little research specifically examining high-risk perinatal women and how their interactions with their infants are related to attachment or relational outcomes. METHODS: This pilot study aims to evaluate, and to explore the acceptability and feasibility, of participating in the Supporting Transitions, Attachment and Relationships (STAR Mums) program, a psychodynamic attachment-based group intervention, for pregnant women with risk factors for attachment difficulties. The STAR Mums program aims to intervene during pregnancy to assist women with risk factors in the transition to parenthood with the desired outcome to improve the quality of mother-infant emotional interactions, regulation and the attachment relationship. This is a mixed-methods design study incorporating both qualitative and quantitative assessments of five groups of five first-time mothers over a 12-month period. CONCLUSIONS: This paper outlines the STAR Mums intervention and protocol for assessing acceptability and feasibility. The STAR Mums program takes a preventative approach and supports early intervention for parents at risk of attachment difficulties with their infants. The results of this study will inform revisions to the current treatment manual and a larger-scale program evaluation to further examine the efficacy of this intervention.
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    Intimate partner violence during infancy and cognitive outcomes in middle childhood: Results from an Australian community-based mother and child cohort study
    Savopoulos, P ; Brown, S ; Anderson, PJ ; Gartland, D ; Bryant, C ; Giallo, R (WILEY, 2022-07)
    The cognitive functioning of children who experience intimate partner violence (IPV) has received less attention than their emotional-behavioral outcomes. Drawing upon data from 615 (48.4% female) 10-year-old Australian-born children and their mothers (9.6% of mothers born in non-English speaking countries) participating in a community-based longitudinal study between 2004 and 2016, this study examined the associations between IPV in infancy and cognition in middle childhood (at age 10). Results showed that IPV in the first 12 months of life was associated with lower general cognitive ability and poorer executive attention but not working memory skills. IPV in middle childhood (in the 10th year postpartum) was not associated with cognition. This study provides evidence for the long-term impact of early life exposure to IPV on children's cognition, and points to the importance of early intervention to optimize development.
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    Exclusive enteral nutrition: An optimal care pathway for use in children with active luminal Crohn's disease
    Burgess, D ; McGrath, KH ; Watson, C ; Collins, T ; Brown, S ; Marks, K ; Dehlsen, K ; Herbison, K ; Landorf, E ; Benn, L ; Fox, J ; Liew, M (WILEY, 2022-04)
    AIM: Exclusive enteral nutrition (EEN) is recommended as a first-line therapy for active luminal paediatric Crohn's disease, by many contemporary consensus guidelines. However, EEN protocols vary internationally. A key enabler for the use of EEN therapy has been identified as the standardisation of protocols. The aim of this study was to develop an optimal care pathway for use of EEN in children with active luminal Crohn's disease. METHODS: A working group of 11 paediatric gastroenterology dietitians and one paediatric gastroenterologist from Australia and New Zealand was convened to develop a standard optimal care pathway. Seven key areas were identified; clinical indications, workup assessments, EEN prescription, monitoring, food reintroduction, partial enteral nutrition and maintenance enteral nutrition. Recent literature was reviewed, assessed according to the National Health and Medical Research Council guidelines, and consensus statements were developed and voted on. Consensus opinion was used where literature gaps existed. RESULTS: A total of nineteen consensus statements from the seven key areas were agreed upon. The consensus statements informed the optimal care pathway for children with active luminal undertaking EEN in Australia and New Zealand. CONCLUSION: This study developed an EEN optimal care pathway to facilitate standardisation of clinical care for children with active luminal Crohn's disease, and hopefully improve clinical outcomes and identify areas for future research.
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    Evaluation of home-based Family Foundations targeting perinatal mental health and couple conflict in Australia
    Giallo, R ; Seymour, M ; Skinner, L ; Fogarty, A ; Field, K ; Mead, J ; Rimington, H ; Galea, K ; Talevski, T ; Ruthven, C ; Brown, S ; Feinberg, M (WILEY, 2022-07)
    Abstract Objectives A formative evaluation of a home‐based family intervention, Family Foundations (FF), targeting parent mental health and conflict in the perinatal period was conducted. The aims were to (a) assess parent satisfaction and recommendations for improvement, (b) identify perceived enablers and barriers to engagement, and (c) obtain preliminary outcome data related to parent mental health, conflict, and coparenting. Methods A mixed‐methods evaluation was conducted with 41 families at risk of or experiencing parental conflict. FF was delivered by two organizations in Australia. Qualitative interviews with parents and FF clinicians were conducted, and intervention outcomes were assessed using parent survey. Results Feasibility of reach and recruitment of the target population was demonstrated. Parents' indicated a high level of satisfaction with all aspects of FF and offered recommendations for improvements to resources and delivery. Service, program, clinician, and family characteristics as enablers and barriers to engagement in FF were identified. Both mothers and partners reported a decrease in their child's exposure to conflict. Mothers also reported a decrease in mental health symptoms and parenting hostility and an increase in positive coparenting behavior. Conclusion Feasibility and acceptability of home‐based FF in the perinatal period had been established, with preliminary evidence of positive outcomes for families. Implications The current findings generate evidence to inform further development of home‐based FF and wider implementation in health and social care services in Australia.
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    Risk of Long COVID in People Infected With Severe Acute Respiratory Syndrome Coronavirus 2 After 2 Doses of a Coronavirus Disease 2019 Vaccine: Community-Based, Matched Cohort Study
    Ayoubkhani, D ; Bosworth, ML ; King, S ; Pouwels, KB ; Glickman, M ; Nafilyan, V ; Zaccardi, F ; Khunti, K ; Alwan, NA ; Walker, AS (OXFORD UNIV PRESS INC, 2022-09-02)
    We investigated long COVID incidence by vaccination status in a random sample of UK adults from April 2020 to November 2021. Persistent symptoms were reported by 9.5% of 3090 breakthrough severe acute respiratory syndrome coronavirus 2 infections and 14.6% of unvaccinated controls (adjusted odds ratio, 0.59 [95% confidence interval, .50-.69]), emphasizing the need for public health initiatives to increase population-level vaccine uptake.
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    Remission of type 2 diabetes and improved diastolic function by combining structured exercise with meal replacement and food reintroduction among young adults: the RESET for REMISSION randomised controlled trial protocol
    Dasgupta, K ; Boule, N ; Henson, J ; Chevalier, S ; Redman, E ; Chan, D ; McCarthy, M ; Champagne, J ; Arsenyadis, F ; Rees, J ; Da Costa, D ; Gregg, E ; Yeung, R ; Hadjiconstantinou, M ; Dattani, A ; Friedrich, MG ; Khunti, K ; Rahme, E ; Fortier, I ; Prado, CM ; Sherman, M ; Thompson, RB ; Davies, MJ ; McCann, GP ; Yates, T (BMJ PUBLISHING GROUP, 2022-09)
    INTRODUCTION: Type 2 diabetes mellitus (T2DM) onset before 40 years of age has a magnified lifetime risk of cardiovascular disease. Diastolic dysfunction is its earliest cardiac manifestation. Low energy diets incorporating meal replacement products can induce diabetes remission, but do not lead to improved diastolic function, unlike supervised exercise interventions. We are examining the impact of a combined low energy diet and supervised exercise intervention on T2DM remission, with peak early diastolic strain rate, a sensitive MRI-based measure, as a key secondary outcome. METHODS AND ANALYSIS: This prospective, randomised, two-arm, open-label, blinded-endpoint efficacy trial is being conducted in Montreal, Edmonton and Leicester. We are enrolling 100 persons 18-45 years of age within 6 years' T2DM diagnosis, not on insulin therapy, and with obesity. During the intensive phase (12 weeks), active intervention participants adopt an 800-900 kcal/day low energy diet combining meal replacement products with some food, and receive supervised exercise training (aerobic and resistance), three times weekly. The maintenance phase (12 weeks) focuses on sustaining any weight loss and exercise practices achieved during the intensive phase; products and exercise supervision are tapered but reinstituted, as applicable, with weight regain and/or exercise reduction. The control arm receives standard care. The primary outcome is T2DM remission, (haemoglobin A1c of less than 6.5% at 24 weeks, without use of glucose-lowering medications during maintenance). Analysis of remission will be by intention to treat with stratified Fisher's exact test statistics. ETHICS AND DISSEMINATION: The trial is approved in Leicester (East Midlands - Nottingham Research Ethics Committee (21/EM/0026)), Montreal (McGill University Health Centre Research Ethics Board (RESET for remission/2021-7148)) and Edmonton (University of Alberta Health Research Ethics Board (Pro00101088). Findings will be shared widely (publications, presentations, press releases, social media platforms) and will inform an effectiveness trial. TRIAL REGISTRATION NUMBER: ISRCTN15487120.
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    Association of COVID-19 With Major Arterial and Venous Thrombotic Diseases: A Population-Wide Cohort Study of 48 Million Adults in England and Wales
    Knight, R ; Walker, V ; Ip, S ; Cooper, JA ; Bolton, T ; Keene, S ; Denholm, R ; Akbari, A ; Abbasizanjani, H ; Torabi, F ; Omigie, E ; Hollings, S ; North, T-L ; Toms, R ; Jiang, X ; Di Angelantonio, E ; Denaxas, S ; Thygesen, JH ; Tomlinson, C ; Bray, B ; Smith, CJ ; Barber, M ; Khunti, K ; Smith, GD ; Chaturvedi, N ; Sudlow, C ; Whiteley, WN ; Wood, AM ; Sterne, JAC (LIPPINCOTT WILLIAMS & WILKINS, 2022-09-20)
    BACKGROUND: Infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) induces a prothrombotic state, but long-term effects of COVID-19 on incidence of vascular diseases are unclear. METHODS: We studied vascular diseases after COVID-19 diagnosis in population-wide anonymized linked English and Welsh electronic health records from January 1 to December 7, 2020. We estimated adjusted hazard ratios comparing the incidence of arterial thromboses and venous thromboembolic events (VTEs) after diagnosis of COVID-19 with the incidence in people without a COVID-19 diagnosis. We conducted subgroup analyses by COVID-19 severity, demographic characteristics, and previous history. RESULTS: Among 48 million adults, 125 985 were hospitalized and 1 319 789 were not hospitalized within 28 days of COVID-19 diagnosis. In England, there were 260 279 first arterial thromboses and 59 421 first VTEs during 41.6 million person-years of follow-up. Adjusted hazard ratios for first arterial thrombosis after COVID-19 diagnosis compared with no COVID-19 diagnosis declined from 21.7 (95% CI, 21.0-22.4) in week 1 after COVID-19 diagnosis to 1.34 (95% CI, 1.21-1.48) during weeks 27 to 49. Adjusted hazard ratios for first VTE after COVID-19 diagnosis declined from 33.2 (95% CI, 31.3-35.2) in week 1 to 1.80 (95% CI, 1.50-2.17) during weeks 27 to 49. Adjusted hazard ratios were higher, for longer after diagnosis, after hospitalized versus nonhospitalized COVID-19, among Black or Asian versus White people, and among people without versus with a previous event. The estimated whole-population increases in risk of arterial thromboses and VTEs 49 weeks after COVID-19 diagnosis were 0.5% and 0.25%, respectively, corresponding to 7200 and 3500 additional events, respectively, after 1.4 million COVID-19 diagnoses. CONCLUSIONS: High relative incidence of vascular events soon after COVID-19 diagnosis declines more rapidly for arterial thromboses than VTEs. However, incidence remains elevated up to 49 weeks after COVID-19 diagnosis. These results support policies to prevent severe COVID-19 by means of COVID-19 vaccines, early review after discharge, risk factor control, and use of secondary preventive agents in high-risk patients.
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    Enhancing the BOADICEA cancer risk prediction model to incorporate new data on RAD51C, RAD51D, BARD1 updates to tumour pathology and cancer incidence
    Lee, A ; Mavaddat, N ; Cunningham, AP ; Carver, T ; Archer, S ; Walter, FM ; Tischkowitz, M ; Roberts, J ; Usher-Smith, J ; Simard, J ; Schmidt, MK ; Devilee, P ; Zadnik, V ; Jurgens, H ; Mouret-Fourme, E ; De Pauw, A ; Rookus, M ; Mooij, TM ; Pharoah, PPD ; Easton, DF ; Antoniou, AC (BMJ PUBLISHING GROUP, 2022-12)
    BACKGROUND: BOADICEA (Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm) for breast cancer and the epithelial tubo-ovarian cancer (EOC) models included in the CanRisk tool (www.canrisk.org) provide future cancer risks based on pathogenic variants in cancer-susceptibility genes, polygenic risk scores, breast density, questionnaire-based risk factors and family history. Here, we extend the models to include the effects of pathogenic variants in recently established breast cancer and EOC susceptibility genes, up-to-date age-specific pathology distributions and continuous risk factors. METHODS: BOADICEA was extended to further incorporate the associations of pathogenic variants in BARD1, RAD51C and RAD51D with breast cancer risk. The EOC model was extended to include the association of PALB2 pathogenic variants with EOC risk. Age-specific distributions of oestrogen-receptor-negative and triple-negative breast cancer status for pathogenic variant carriers in these genes and CHEK2 and ATM were also incorporated. A novel method to include continuous risk factors was developed, exemplified by including adult height as continuous. RESULTS: BARD1, RAD51C and RAD51D explain 0.31% of the breast cancer polygenic variance. When incorporated into the multifactorial model, 34%-44% of these carriers would be reclassified to the near-population and 15%-22% to the high-risk categories based on the UK National Institute for Health and Care Excellence guidelines. Under the EOC multifactorial model, 62%, 35% and 3% of PALB2 carriers have lifetime EOC risks of <5%, 5%-10% and >10%, respectively. Including height as continuous, increased the breast cancer relative risk variance from 0.002 to 0.010. CONCLUSIONS: These extensions will allow for better personalised risks for BARD1, RAD51C, RAD51D and PALB2 pathogenic variant carriers and more informed choices on screening, prevention, risk factor modification or other risk-reducing options.
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    Does place matter in the implementation of an evidence-based program policy in an Australian place-based initiative for children?
    Burgemeister, FC ; Hokke, S ; Crawford, SB ; Hackworth, NJ ; Nicholson, JM (WILEY-HINDAWI, 2022-11)
    Policy-mandated requirements for use of evidence-based programs (EBP) in place-based initiatives are becoming more common. Little attention has been paid to the geographic aspects of uneven market development and urbanicity in implementing EBPs in large place-based initiatives. The aim of this study was to explore geographic variation in knowledge, attitudes, and experiences of service providers who implemented an EBP policy in Australia's largest place-based initiative for children, Communities for Children. A cross-sectional online survey of Communities for Children service providers was conducted in 2018-2019, yielding 197 participants from all of Australia's eight states and territories. Relationships between two measures of 'place' (thick and thin market states; urbanicity: urban, regional and remote) and study-designed measures of knowledge, attitudes, and implementation experiences were analyzed using adjusted logistic and multinomial regressions. Participants from thin market states (outside the Eastern Seaboard) were more resistant to the policy and experienced greater implementation challenges than those from thick market states (Eastern Seaboard). Regional participants reported greater knowledge about EBPs but experienced greater dissatisfaction and implementation challenges with the policy than both urban and remote participants. Our study found that place does matter when implementing EBPs in a place-based initiative.