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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
In safe hands: child health data storage, linkage and consent for use.
While there is potential for societal benefit from linkage and integration of large datasets, there are gaps in our understanding of the implications for children and young people, and limited inclusion of their views within this discourse. We aimed to understand the views and expectations of children, young people and their parents/caregivers in Aotearoa New Zealand regarding child health data storage, linkage and consent for use. This qualitative study included 24 Māori and non-Māori children, young people and their families across five focus groups, recruited from a community-based health service. A mixed Māori and non-Māori research team facilitated participant recruitment and data collection. Child, adolescent and parent/caregiver groups were held separately. Sessions were audio-recorded and the verbatim transcripts were analysed thematically. We identified three themes: (i) I am more than a number: seeing patients as people; (ii) In safe hands: data as power; and (iii) What are your intentions with my data? Consent as an active relationship. A key challenge was the reductive and stigmatizing potential of data integration for minoritised groups. Hypothetical discussions of data sharing and linkage were contingent on trust between the participant and the health professional, with negotiated data ownership. Consent was conceived as an active relationship needing renewal and renegotiation as children reached adulthood. Current consent processes for ongoing use of child data require further deliberation. Without a strong ethical and child rights-based approach to issues of child health data management, consent and linkage, we risk exacerbating health inequities and experiences of breach of trust.
Criterion validation of nutrient profiling systems: a systematic review and meta-analysis
Background: Nutrient profiling systems (NPSs) use algorithms to evaluate the nutritional quality of foods and beverages. Criterion validation, which assesses the relationship between consuming foods rated as healthier by the NPS and objective measures of health, is essential to ensure the accuracy of NPSs. Objective: We examined and compared NPSs that have undergone criterion validity testing in relation to diet-related disease risk and risk markers. Methods: Academic databases were searched for prospective cohort and cross-sectional studies published before November, 2022. NPSs were eligible if they incorporated multiple nutrients or food components using an algorithm to determine an overall summary indicator (e.g., a score or rank) for individual foods. Studies were included if they assessed the criterion validity of an eligible NPS. Validation evidence was first summarized in narrative form by NPS, with random effects meta-analysis where ≥2 prospective cohort studies assessed the same NPS and outcomes. Results: Of 4519 publications identified, 29 describing 9 NPSs were included in the review. The Nutri-Score NPS was assessed as having substantial criterion validation evidence. Highest compared with lowest diet quality as defined by the Nutri-Score was associated with significantly lower risk of cardiovascular disease (hazard ratio [HR]: 0.74; 95% confidence interval [CI]: 0.59, 0.93; n = 6), cancer (HR: 0.75; 95% CI: 0.59, 0.94; n = 5), all-cause mortality (HR: 0.74; 95% CI; 0.59, 0.91; n = 4) and change in body mass index (HR: 0.68; 95% CI: 0.50, 0.92; n = 3). The Food Standards Agency NPS, Health Star Rating, Nutrient Profiling Scoring Criterion, Food Compass, Overall Nutrition Quality Index, and the Nutrient-Rich Food Index were determined as having intermediate criterion validation evidence. Two other NPSs were determined as having limited criterion validation evidence. Conclusions: We found limited criterion validation studies compared with the number of NPSs estimated to exist. Greater emphasis on conducting and reporting on criterion validation studies across varied contexts may improve the confidence in existing NPSs.
Estimating the effect of COVID-19 on trial design characteristics: A registered report
There have been reports of poor-quality research during the COVID-19 pandemic. This registered report assessed design characteristics of registered clinical trials for COVID-19 compared to non-COVID-19 trials to empirically explore the design of clinical research during a pandemic and how it compares to research conducted in non-pandemic times. We did a retrospective cohort study with a 1: 1 ratio of interventional COVID-19 registrations to non-COVID-19 registrations, with four trial design outcomes: use of control arm, randomization, blinding and prospective registration. Logistic regression was used to estimate the odds ratio of investigating COVID-19 versus not COVID-19 and estimate direct and total effects of investigating COVID-19 for each outcome. The primary analysis showed a positive direct and total effect of COVID-19 on the use of control arms and randomization. It showed a negative direct effect of COVID-19 on blinding but no evidence of a total effect. There was no evidence of an effect on prospective registration. Taken together with secondary and sensitivity analyses, our findings are inconclusive but point towards a higher prevalence of key design characteristics in COVID-19 trials versus controls. The findings do not support much existing COVID-19 research quality literature, which generally suggests that COVID-19 led to a reduction in quality. Limitations included some data quality issues, minor deviations from the pre-registered plan and the fact that trial registrations were analysed which may not accurately reflect study design and conduct. Following in-principle acceptance, the approved stage 1 version of this manuscript was pre-registered on the Open Science Framework at https://doi.org/10.17605/OSF.IO/5YAEB. This pre-registration was performed prior to data analysis.
The Open Science Framework at Oxford
The Bodleian Libraries, in partnership with MSD, are operating a 2 year pilot of institutional membership of the Open Science Framework at (OSF) Oxford. This session will begin an overview of the Open Science Framework and how it fits into Oxford’s wider Research Data Management ecosystem. This will be followed by some researchers at Oxford presenting their experiences with OSF.
Completeness and consistency of primary outcome reporting in COVID-19 publications in the early pandemic phase: a descriptive study
Background: The COVID-19 pandemic saw a steep increase in the number of rapidly published scientific studies, especially early in the pandemic. Some have suggested COVID-19 trial reporting is of lower quality than typical reports, but there is limited evidence for this in terms of primary outcome reporting. The objective of this study was to assess the prevalence of completely defined primary outcomes reported in registry entries, preprints, and journal articles, and to assess consistent primary outcome reporting between these sources. Methods: This is a descriptive study of a cohort of registered interventional clinical trials for the treatment and prevention of COVID-19, drawn from the DIssemination of REgistered COVID-19 Clinical Trials (DIRECCT) study dataset. The main outcomes are: 1) Prevalence of complete primary outcome reporting; 2) Prevalence of consistent primary outcome reporting between registry entry and preprint as well as registry entry and journal article pairs. Results: We analyzed 87 trials with 116 corresponding publications (87 registry entries, 53 preprints and 63 journal articles). All primary outcomes were completely defined in 47/87 (54%) registry entries, 31/53 (58%) preprints and 44/63 (70%) journal articles. All primary outcomes were consistently reported in 13/53 (25%) registry-preprint pairs and 27/63 (43%) registry-journal article pairs. No primary outcome was specified in 13/53 (25%) preprints and 8/63 (13%) journal articles. In this sample, complete primary outcome reporting occurred more frequently in trials with vs. without involvement of pharmaceutical companies (76% vs. 45%), and in RCTs vs. other study designs (68% vs. 49%). The same pattern was observed for consistent primary outcome reporting (with vs. without pharma: 56% vs. 12%, RCT vs. other: 43% vs. 22%). Conclusions: In COVID-19 trials in the early phase of the pandemic, all primary outcomes were completely defined in 54%, 58%, and 70% of registry entries, preprints and journal articles, respectively. Only 25% of preprints and 43% of journal articles reported primary outcomes consistent with registry entries.
Clinical Outcomes After Viremia Among People Receiving Dolutegravir vs Efavirenz-Based First-line Antiretroviral Therapy in South Africa.
BACKGROUND: We aimed to compare clinical outcomes after viremia between dolutegravir vs efavirenz-based first-line antiretroviral therapy (ART) as evidence is lacking outside clinical trials in resource-limited settings. METHODS: We conducted a retrospective cohort analysis with routine data from 59 South African clinics. We included people with HIV aged ≥15 years receiving first-line tenofovir disoproxil fumarate, lamivudine, dolutegravir (TLD) or tenofovir disoproxil fumarate, emtricitabine, efavirenz (TEE) and with first viremia (≥50 copies/mL) between June and November 2020. We used multivariable modified Poisson regression models to compare retention in care and viral suppression (<50 copies/mL) after 12 months between participants on TLD vs TEE. RESULTS: At first viremia, among 9657 participants, 6457 (66.9%) were female, and the median age (interquartile range [IQR]) was 37 (31-44) years; 7598 (78.7%) were receiving TEE and 2059 (21.3%) TLD. Retention in care was slightly higher in the TLD group (84.9%) than TEE (80.8%; adjusted risk ratio [aRR], 1.03; 95% CI, 1.00-1.06). Of 6569 participants retained in care with a 12-month viral load, viral suppression was similar between the TLD (78.9%) and TEE (78.8%) groups (aRR, 1.02; 95% CI, 0.98-1.05). However, 3368 participants changed ART during follow-up: the majority from TEE to first-line TLD (89.1%) or second-line (TLD 3.4%, zidovudine/emtricitabine/lopinavir-ritonavir 2.1%). In a sensitivity analysis among the remaining 3980 participants who did not change ART during follow-up and had a 12-month viral load, viral suppression was higher in the TLD (78.9%) than TEE (74.9%) group (aRR, 1.07; 95% CI, 1.03-1.12). CONCLUSIONS: Among people with viremia on first-line ART, dolutegravir was associated with slightly better retention in care and similar or better viral suppression than efavirenz.
The place of digital triage in a complex healthcare system: An interview study with key stakeholders in Australia's national provider
Background: Digital triage tools such as telephone advice and online symptom checkers are now commonplace in health systems internationally. Research has focused on consumers’ adherence to advice, health outcomes, satisfaction, and the degree to which these services manage demand for general practice or emergency departments. Such studies have had mixed findings, leaving equivocal the role of these services in healthcare. Objective: We examined stakeholders’ perspectives on Healthdirect, Australia's national digital triage provider, focusing on its role in the health system, and barriers to operation, in the context of the COVID-19 pandemic. Methods: Key stakeholders took part in semi-structured interviews conducted online in the third quarter of 2021. Transcripts were coded and thematically analysed. Results: Participants (n = 41) were Healthdirect staff (n = 13), employees of Primary Health Networks (PHNs; n = 12), clinicians (n = 9), shareholder representatives (n = 4), consumer representatives (n = 2) and other policymakers (n = 1). Eight themes emerged from the analysis: (1) information and guidance in navigating the system, (2) efficiency through appropriate care, (3) value for consumers? (4) the difficulties in triage at a distance, (5) competition and the unfulfilled promise of integration, (6) challenges in promoting Healthdirect, (7) monitoring and evaluating digital triage services and (8) rapid change, challenge and opportunity from COVID-19. Conclusion: Stakeholders varied in their views of the purpose of Healthdirect's digital triage services. They identified challenges in lack of integration, competition, and the limited public profile of the services, issues largely reflective of the complexity of the policy and health system landscape. There was acknowledgement of the value of the services during the COVID-19 pandemic, and an expectation of them realising greater potential in the wake of the rapid uptake of telehealth.
Longitudinal associations between socioeconomic position and overall health of children with chronic kidney disease and their carers.
BACKGROUND: Disadvantaged socioeconomic position (SEP) is an important predictor of poor health in children with chronic kidney disease (CKD). The time course over which SEP influences the health of children with CKD and their carers is unknown. METHODS: This prospective longitudinal study included 377 children, aged 6-18 years with CKD (stages I-V, dialysis, and transplant), and their primary carers. Mixed effects ordinal regression was performed to assess the association between SEP and carer-rated child health and carer self-rated health over a 4-year follow-up. RESULTS: Adjusted for CKD stage, higher family household income (adjusted odds ratio (OR) (95% CI) 3.3, 1.8-6.0), employed status of primary carers (1.7, 0.9-3.0), higher carer-perceived financial status (2.6, 1.4-4.8), and carer home ownership (2.2, 1.2-4.0) were associated with better carer-rated child health. Household income also had a differential effect on the carer's self-rated health over time (p = 0.005). The predicted probabilities for carers' overall health being 'very good' among lower income groups at 0, 2, and 4 years were 0.43 (0.28-0.60), 0.34 (0.20-0.51), and 0.25 (0.12-0.44), respectively, and 0.81 (0.69-0.88), 0.84 (0.74-0.91), and 0.88 (0.76-0.94) for carers within the higher income group. CONCLUSIONS: Carers and their children with CKD in higher SEP report better overall child and carer health compared with those in lower SEP. Carers of children with CKD in low-income households had poorer self-rated health compared with carers in higher-income households at baseline, and this worsened over time. These cumulative effects may contribute to health inequities between higher and lower SEP groups over time. Graphical abstract A higher resolution version of the Graphical abstract is available as Supplementary information.
Selling antibiotics without prescriptions among community pharmacies and drug outlets: a simulated client study from Ghana
Background: Selling antibiotics without prescriptions is mostly illegal worldwide, including in Ghana, and promotes antimicrobial resistance. We evaluated the prevalence and practice of selling antibiotics without prescriptions among community pharmacies (CPs) and drug outlets, for the first time, in Ghana to quantify and characterize this issue to inform future interventions. Research design and methods: Two scenarios utilizing the Simulated Client Methodology were enacted: an upper respiratory tract infection of viral origin (scenario one); and pediatric diarrhea (scenario two). CPs/Outlets were selected by stratified proportional random sampling from four metropolitan cities (~14% of the total Ghanaian population). Selling of antibiotics was assessed at three demand levels and its overall prevalence was estimated, then stratified by the study variables. Results: Out of the 265 sampled CPs/outlets, the prevalence of selling antibiotic without prescription was 88.3% (n = 234/265), with variations not only across the four regions [92.5% (n = 123/133) in Kumasi, 87.5% (n = 14/16) in Cape Coast, 84.1% (n = 69/82) in Accra, and 82.4% (n = 28/34) in Tamale] but also across CPs [90% (n = 121/134)] and drug outlets [86% (n = 113/131)]. Conclusions: A very high prevalence/sub-optimal practice of selling antibiotics without prescriptions was found. This highlights the need to increase compliance with antibiotic dispensing legislation through evidence-based interventions including education of key stakeholders.