Diverse response of shallow lake water levels to decadal weather patterns in a heterogeneous glacial Boreal Plains landscape

To examine the relative controls of landscape and climate on spatial variability, we measured water level dynamics of shallow lakes over two decades that represent both the heterogeneity of surficial geology classifications, and thus the potential range in surface and groundwater connectivity, and the long‐term weather patterns of the Boreal Plain hydrogeoclimatic setting. Large ranges in shallow lakes water levels (between 0.25 and 2 m) were observed corresponding to extremes in precipitation relative to the long‐term mean precipitation over the study period. We found low concurrence in water level dynamics among four detailed study lakes that received the same meteorological weather signal, but were located in different surficial geology texture classifications that incorporated important landscape parameters associated with lake water balance and storage. Surficial geology classification alone did not, however, distinguish between different ranges in lake water level measured in a broader synoptic survey of 26 lakes across the region. Thus, simple surficial geology classifications cannot alone be applied to classify Boreal Plain lake water level dynamics and other controls, notably landscape position, must also be considered. We further show that inter‐annual variability in lake water levels was significantly greater than seasonal variability in this hydrogeoclimatic setting. This emphasizes the need for studies of sufficient length to capture weather extremes that include periods of wetting and drying, and demonstrates how observed magnitudes of water level variability, and lake function, can be an artefact of study length and initiation date. These findings provide a foundation to test and calibrate conceptual understanding of the wider controls of lake water levels to form holistic frameworks to mitigate ecological and societal impacts due to hydrological changes under climate and anthropogenic disturbance within and between hydrogeoclimatic settings

Deaths from cardiovascular disease involving anticoagulants: a systematic synthesis of coroners' case reports

Background The global burden of cardiovascular disease (CVD) is forecast to increase, and anticoagulants will remain important medicines for its management. Coroners' Prevention of Future Death reports (PFDs) provide valuable insights that may enable safer and more effective use of these agents. Aim To identify CVD-related PFDs involving anticoagulants. Design & setting Case series of coronial reports in England and Wales between 2013 and 2019. Method A total of 3037 PFDs were screened for eligibility. PFDs were included where CVD and an anticoagulant caused or contributed to the death. Included cases were descriptively analysed and content analysis was used to assess concerns raised by coroners and who had responded to them. Results The study identified 113 CVD-related PFDs involving anticoagulants. Warfarin (36%, n = 41), enoxaparin (11%, n = 12), and rivaroxaban (11%, n = 12) were the most common anticoagulants reported. Concerns most frequently raised by coroners included poor systems (31%), poor communication (25%), and failures to keep accurate medical records (25%). These concerns were most often directed to NHS trusts (29%), hospitals (10%), and general practices (8%). Nearly two-thirds (60%) of PFDs had not received responses from such organisations, which are mandatory under regulation 28 of the Coroners' (Investigations) Regulations 2013. A publicly available tool has been created by the authors (https://preventabledeathstracker.net), which displays coroners’ reports in England and Wales to streamline access, and identify important lessons to prevent future deaths. Conclusion National organisations, healthcare professionals, and prescribers should take actions to address the concerns of coroners in PFDs to improve the safe use of anticoagulants in patients with CVD

A Cross-Sectional Study of All Clinicians’ Conflict of Interest Disclosures to NHS Hospital Employers in England 2015-2016

Objective We set out to document how NHS trusts in the UK record and share disclosures of conflict of interest by their employees. Design Cross-sectional study of responses to a Freedom of Information Act request for Gifts and Hospitality Registers. Setting NHS Trusts (secondary/tertiary care organisations) in England. Participants 236 Trusts were contacted, of which 217 responded. Main outcome measures We assessed all disclosures for completeness and openness, scoring them for achieving each of five measures of transparency. Results 185 Trusts (78%) provided a register. 71 Trusts did not respond within the 28 day time limit required by the FoIA. Most COI registers were incomplete by design, and did not contain the information necessary to assess conflicts of interest. 126/185 (68%) did not record the names of recipients. 47/185 (25%) did not record the cash value of the gift or hospitality. Only 31/185 registers (16%) contained the names of recipients, the names of donors, and the cash amounts received. 18/185 (10%) contained none of: recipient name, donor name, and cash amount. Only 15 Trusts had their disclosure register publicly available online (6%). We generated a transparency index assessing whether each Trust met the following criteria: responded on time; provided a register; had a register with fields identifying donor, recipient, and cash amount; provided a register in a format that allowed further analysis; and had their register publicly available online. Mean attainment was 1.9/5; no NHS trust met all five criteria. Conclusion Overall, recording of employees’ conflicts of interest by NHS trusts is poor. None of the NHS Trusts in England met all transparency criteria. 19 did not respond to our FoIA requests, 51 did not provide a Gifts and Hospitality Register and only 31 of the registers provided contained enough information to assess employees’ conflicts of interest. Despite obligations on healthcare professionals to disclose conflicts of interest, and on organisations to record these, the current system for logging and tracking such disclosures is not functioning adequately. We propose a simple national template for reporting conflicts of interest, modelled on the US ‘Sunshine Act’

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

E-cigarette manufacturers' compliance with clinical trial reporting expectations: a case series of registered trials by Juul Labs.

BACKGROUND: Electronic cigarettes (e-cigarettes) are a frequently debated topic in public health. It is essential that clinical trials examining e-cigarettes are fully and accurately reported, especially given long-standing concerns about tobacco industry research. We assess the reporting of clinical trials sponsored by Juul Labs, the largest e-cigarette company in the USA, against accepted reporting standards. METHODS: We searched ClinicalTrials.gov for all trials sponsored by Juul Labs and determined those with registry data consistent with coverage by the Food and Drug Administration (FDA) Amendments Act 2007 (FDAAA). For trials with a primary completion date more than 1 year earlier, we searched ClinicalTrials.gov, the academic literature and a Juul-funded research database (JLI Science) for results. For located results, we compared reported outcomes with registered outcomes in line with Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. RESULTS: We located five registered trials sponsored by Juul Labs that appeared covered by the FDAAA 2007 in the public data. All five trials did not have results available on ClinicalTrials.gov. We found one publication and four poster presentations reporting results for four of the five covered trials outside of ClinicalTrials.gov. Of 61 specified outcomes, 28 were CONSORT compliant. Specific outcome reporting issues are detailed. DISCUSSION: Our findings raise substantial concerns regarding these trials. Clinicians, public health professionals, and the public cannot make informed choices about the benefits or hazards of e-cigarettes if the results of clinical trials are not completely and transparently reported. Clarification and potential enforcement of reporting laws may be required

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