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Changes in soft drinks purchased by British households associated with the UK soft drinks industry levy: a controlled interrupted time series analysis.
OBJECTIVE: To determine changes in household purchases of drinks 1 year after implementation of the UK soft drinks industry levy (SDIL). DESIGN: Controlled interrupted time series. PARTICIPANTS: Households reporting their purchasing to a market research company (average weekly n=22 091), March 2014 to March 2019. INTERVENTION: A two-tiered tax levied on soft drinks manufacturers, announced in March 2016 and implemented in April 2018. Drinks with ≥8 g sugar/100 mL (high tier) are taxed at £0.24/L, drinks with ≥5 to <8 g sugar/100 mL (low tier) are taxed at £0.18/L. MAIN OUTCOME MEASURES: Absolute and relative differences in the volume of, and amount of sugar in, soft drinks categories, all soft drinks combined, alcohol and confectionery purchased per household per week 1 year after implementation. RESULTS: In March 2019, compared with the counterfactual, purchased volume of high tier drinks decreased by 140.8 mL (95% CI 104.3 to 177.3 mL) per household per week, equivalent to 37.8% (28.0% to 47.6%), and sugar purchased in these drinks decreased by 16.2 g (13.5 to 18.8 g), or 42.6% (35.6% to 49.6%). Purchases of low tier drinks decreased by 170.5 mL (154.5 to 186.5 mL) or 85.8% (77.8% to 93.9%), with an 11.5 g (9.1 to 13.9 g) reduction in sugar in these drinks, equivalent to 87.8% (69.2% to 106.4%). When all soft drinks were combined irrespective of levy tier or eligibility, the volume of drinks purchased increased by 188.8 mL (30.7 to 346.9 mL) per household per week, or 2.6% (0.4% to 4.7%), but sugar decreased by 8.0 g (2.4 to 13.6 g), or 2.7% (0.8% to 4.5%). Purchases of confectionery and alcoholic drinks did not increase. CONCLUSIONS: Compared with trends before the SDIL was announced, 1 year after implementation, volume of all soft drinks purchased combined increased by 189 mL, or 2.6% per household per week. The amount of sugar in those drinks was 8 g, or 2.7%, lower per household per week. Further studies should determine whether and how apparently small effect sizes translate into health outcomes. TRIAL REGISTRATION NUMBER: ISRCTN18042742.
Optimising process and methods for a living systematic review - 30 search updates and three review updates later.
Living systematic reviews (LSR) are systematic reviews that are regularly updated, allowing new evidence to be incorporated as it becomes available. LSR are ideally suited to policy-relevant topics where there is uncertainty and new evidence will likely impact the interpretation and/or certainty of outcomes. To be of benefit, updates must be published in a timely manner. Many LSR do not publish more than one update. As authors of a systematic review that has been 'living' for two years, with monthly search updates and three full updates published in this time, we describe the steps in our LSR process with the aim of informing and assisting authors carrying out their own regularly updated LSR. Key features of the process that require consideration are as follows: specifying the frequency of searches and triggers for full updates in the protocol; stakeholder input; publishing and disseminating monthly search findings. A strong team, incorporating methodological and topic expertise, with core members that meet regularly is essential. Regular search updates make it important to have a clear cyclical schedule of activity. To achieve timely updates this process should be streamlined, for example, using automated monthly searches, and systematic reviewing software for screening. LSR provide a unique opportunity to incorporate stakeholder feedback; as soon as a review update is complete you may be planning your next, and can incorporate useful feedback. We suggest seeking feedback on your findings and methods and, where appropriate, incorporating them with transparency.
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.
Preventable deaths involving opioids in England and Wales, 2013-2022: a systematic case series of coroners' reports.
BACKGROUND: Opioid deaths have increased in England and Wales. Coroners' Prevention of Future Deaths reports (PFDs) provide important insights that may enable safer use and avert harms, yet reports implicating opioids have not been synthesized. We aimed to identify opioid-related PFDs and explore coroners' concerns to prevent future deaths. METHODS: In this systematic case series, we screened 3897 coronial PFDs dated between 01 July 2013 and 23 February 2022, obtained by web scraping the UK's Courts and Tribunals Judiciary website. PFDs were included when an opioid was implicated in the death. Included PFDs were descriptively analysed, and content analysis was used to assess concerns reported by coroners. RESULTS: Opioids were involved in 219 deaths reported in PFDs (5·6% of PFDs), equating to 4418 years of life lost (median 33 years/person). Morphine (29%), methadone (23%) and diamorphine (16%) were the most common implicated opioids. Coroners most frequently raised concerns regarding systems and protocols (52%) or safety issues (15%). These concerns were most often addressed to National Health Service (NHS) organizations (51%), but response rates were low overall (47%). CONCLUSIONS: Opioids could be used more safely if coroners' concerns in PFDs were addressed by national organizations such as NHS bodies, government agencies and policymakers, as well as individual prescribing clinicians.
Ethnic differences in the indirect effects of the COVID-19 pandemic on clinical monitoring and hospitalisations for non-COVID conditions in England: a population-based, observational cohort study using the OpenSAFELY platform
Background: The COVID-19 pandemic disrupted healthcare and may have impacted ethnic inequalities in healthcare. We aimed to describe the impact of pandemic-related disruption on ethnic differences in clinical monitoring and hospital admissions for non-COVID conditions in England. Methods: In this population-based, observational cohort study we used primary care electronic health record data with linkage to hospital episode statistics data and mortality data within OpenSAFELY, a data analytics platform created, with approval of NHS England, to address urgent COVID-19 research questions. We included adults aged 18 years and over registered with a TPP practice between March 1, 2018, and April 30, 2022. We excluded those with missing age, sex, geographic region, or Index of Multiple Deprivation. We grouped ethnicity (exposure), into five categories: White, Asian, Black, Other, and Mixed. We used interrupted time-series regression to estimate ethnic differences in clinical monitoring frequency (blood pressure and Hba1c measurements, chronic obstructive pulmonary disease and asthma annual reviews) before and after March 23, 2020. We used multivariable Cox regression to quantify ethnic differences in hospitalisations related to diabetes, cardiovascular disease, respiratory disease, and mental health before and after March 23, 2020. Findings: Of 33,510,937 registered with a GP as of 1st January 2020, 19,064,019 were adults, alive and registered for at least 3 months, 3,010,751 met the exclusion criteria and 1,122,912 were missing ethnicity. This resulted in 14,930,356 adults with known ethnicity (92% of sample): 86.6% were White, 7.3% Asian, 2.6% Black, 1.4% Mixed ethnicity, and 2.2% Other ethnicities. Clinical monitoring did not return to pre-pandemic levels for any ethnic group. Ethnic differences were apparent pre-pandemic, except for diabetes monitoring, and remained unchanged, except for blood pressure monitoring in those with mental health conditions where differences narrowed during the pandemic. For those of Black ethnicity, there were seven additional admissions for diabetic ketoacidosis per month during the pandemic, and relative ethnic differences narrowed during the pandemic compared to the White ethnic group (Pre-pandemic hazard ratio (HR): 0.50, 95% confidence interval (CI) 0.41, 0.60, Pandemic HR: 0.75, 95% CI: 0.65, 0.87). There was increased admissions for heart failure during the pandemic for all ethnic groups, though highest in those of White ethnicity (heart failure risk difference: 5.4). Relatively, ethnic differences narrowed for heart failure admission in those of Asian (Pre-pandemic HR 1.56, 95% CI 1.49, 1.64, Pandemic HR 1.24, 95% CI 1.19, 1.29) and Black ethnicity (Pre-pandemic HR 1.41, 95% CI: 1.30, 1.53, Pandemic HR: 1.16, 95% CI 1.09, 1.25) compared with White ethnicity. For other outcomes the pandemic had minimal impact on ethnic differences. Interpretation: Our study suggests that ethnic differences in clinical monitoring and hospitalisations remained largely unchanged during the pandemic for most conditions. Key exceptions were hospitalisations for diabetic ketoacidosis and heart failure, which warrant further investigation to understand the causes. Funding: LSHTM COVID-19 Response Grant ( DONAT15912).
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.
Dissemination of Registered COVID-19 Clinical Trials (DIRECCT): a cross-sectional study.
BACKGROUND: The results of clinical trials should be completely and rapidly reported during public health emergencies such as COVID-19. This study aimed to examine when, and where, the results of COVID-19 clinical trials were disseminated throughout the first 18 months of the pandemic. METHODS: Clinical trials for COVID-19 treatment or prevention were identified from the WHO ICTRP database. All interventional trials with a registered completion date ≤ 30 June 2021 were included. Trial results, published as preprints, journal articles, or registry results, were located using automated and manual techniques across PubMed, Google Scholar, Google, EuropePMC, CORD-19, the Cochrane COVID-19 Study Register, and clinical trial registries. Our main analysis reports the rate of dissemination overall and per route, and the time from registered completion to results using Kaplan-Meier methods, with additional subgroup and sensitivity analyses reported. RESULTS: Overall, 1643 trials with completion dates ranging from 46 to 561 days prior to the start of results searches were included. The cumulative probability of reporting was 12.5% at 3 months from completion, 21.6% at 6 months, and 32.8% at 12 months. Trial results were most commonly disseminated in journals (n = 278 trials, 69.2%); preprints were available for 194 trials (48.3%), 86 (44.3%) of which converted to a full journal article. Trials completed earlier in the pandemic were reported more rapidly than those later in the pandemic, and those involving ivermectin were more rapidly reported than other common interventions. Results were robust to various sensitivity analyses except when considering only trials in a "completed" status on the registry, which substantially increased reporting rates. Poor trial registry data on completion status and dates limits the precision of estimates. CONCLUSIONS: COVID-19 trials saw marginal increases in reporting rates compared to standard practice; most registered trials failed to meet even the 12-month non-pandemic standard. Preprints were common, complementing journal publication; however, registries were underutilized for rapid reporting. Maintaining registry data enables accurate representation of clinical research; failing to do so undermines these registries' use for public accountability and analysis. Addressing rapid reporting and registry data quality must be emphasized at global, national, and institutional levels.
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.