Using clinical trial data and linked administrative health data to reduce the risk of adverse events associated with the uptake of newly released drugs by older Australians: a model process

BackgroundThe study was undertaken to evaluate the contribution of a process which uses clinical trial data plus linked de-identified administrative health data to forecast potential risk of adverse events associated with the use of newly released drugs by older Australian patients. MethodsThe study uses publicly available data from the clinical trials of a newly released drug to ascertain which patient age groups, gender, comorbidities and co-medications were excluded in the trials. It then uses linked de-identified hospital morbidity and medications dispensing data to investigate the comorbidities and co-medications of patients who suffer from the target morbidity of the new drug and who are the likely target population for the drug. The clinical trial information and the linked morbidity and medication data are compared to assess which patient groups could potentially be at risk of an adverse event associated with use of the new drug. ResultsApplying the model in a retrospective real-world scenario identified that the majority of the sample group of Australian patients aged 65 years and over with the target morbidity of the newly released COX-2-selective NSAID rofecoxib also suffered from a major morbidity excluded in the trials of that drug, indicating a substantial potential risk of adverse events amongst those patients. This risk was borne out in post-release morbidity and mortality associated with use of that drug. ConclusionsClinical trial data and linked administrative health data can together support a prospective assessment of patient groups who could be at risk of an adverse event if they are prescribed a newly released drug in the context of their age, gender, comorbidities and/or co-medications. Communication of this independent risk information to prescribers has the potential to reduce adverse events in the period after the release of the new drug, which is when the risk is greatest. Note: The terms \u27adverse drug reaction\u27 and \u27adverse drug event\u27 have come to be used interchangeably in the current literature. For consistency, the authors have chosen to use the wider term \u27adverse drug event\u27 (ADE). <br /

Seasonal variability of sea surface height in the coastal waters and deep basins of the Nordic Seas

Sea surface height measured by the Envisat radar altimeter over open ocean and from leads in sea ice are combined to generate a complete view of variability in the Nordic Seas, geographically and seasonally. The observed seasonal variability is decomposed using empirical orthogonal functions, and is consistent with seasonal variations in steric and dynamic forcing. Wintertime increase in sea surface height on the east Greenland shelf is hypothesised to be caused by wind-forced downwelling, which provides direct evidence for the regional play of coastal dynamics. High levels of eddy kinetic energy around the sea ice edge in Fram Strait, and off east Greenland and Svalbard are consistent with the interaction of the wind with the ice edge

Combining qualitative and quantitative operational research methods to inform quality improvement in pathways that span multiple settings

BACKGROUND: Improving integration and continuity of care across sectors within resource constraints is a priority in many health systems. Qualitative operational research methods of problem structuring have been used to address quality improvement in services involving multiple sectors but not in combination with quantitative operational research methods that enable targeting of interventions according to patient risk. We aimed to combine these methods to augment and inform an improvement initiative concerning infants with congenital heart disease (CHD) whose complex care pathway spans multiple sectors. METHODS: Soft systems methodology was used to consider systematically changes to services from the perspectives of community, primary, secondary and tertiary care professionals and a patient group, incorporating relevant evidence. Classification and regression tree (CART) analysis of national audit datasets was conducted along with data visualisation designed to inform service improvement within the context of limited resources. RESULTS: A 'Rich Picture' was developed capturing the main features of services for infants with CHD pertinent to service improvement. This was used, along with a graphical summary of the CART analysis, to guide discussions about targeting interventions at specific patient risk groups. Agreement was reached across representatives of relevant health professions and patients on a coherent set of targeted recommendations for quality improvement. These fed into national decisions about service provision and commissioning. CONCLUSIONS: When tackling complex problems in service provision across multiple settings, it is important to acknowledge and work with multiple perspectives systematically and to consider targeting service improvements in response to confined resources. Our research demonstrates that applying a combination of qualitative and quantitative operational research methods is one approach to doing so that warrants further consideration

Estimating the sea ice floe size distribution using satellite altimetry: Theory, climatology, and model comparison

In sea-ice-covered areas, the sea ice floe size distribution (FSD) plays an important role in many processes affecting the coupled sea-ice-ocean-atmosphere system. Observations of the FSD are sparse - traditionally taken via a painstaking analysis of ice surface photography - and the seasonal and inter-annual evolution of floe size regionally and globally is largely unknown. Frequently, measured FSDs are assessed using a single number, the scaling exponent of the closest power-law fit to the observed floe size data, although in the absence of adequate datasets there have been limited tests of this "power-law hypothesis". Here we derive and explain a mathematical technique for deriving statistics of the sea ice FSD from polar-orbiting altimeters, satellites with sub-daily return times to polar regions with high along-track resolutions. Applied to the CryoSat-2 radar altimetric record, covering the period from 2010 to 2018, and incorporating 11 million individual floe samples, we produce the first pan-Arctic climatology and seasonal cycle of sea ice floe size statistics. We then perform the first pan-Arctic test of the power-law hypothesis, finding limited support in the range of floe sizes typically analyzed in photographic observational studies. We compare the seasonal variability in observed floe size to fully coupled climate model simulations including a prognostic floe size and thickness distribution and coupled wave model, finding good agreement in regions where modeled ocean surface waves cause sea ice fracture

Facial emotion recognition and alexithymia in adults with somatoform disorders

The primary aim of this study was to investigate facial emotion recognition (FER) in patients with somatoform disorders (SFD). Also of interest was the extent to which concurrent alexithymia contributed to any changes in emotion recognition accuracy. Twenty patients with SFD and 20 healthy, age, sex and education matched, controls were assessed with the Facially Expressed Emotion Labelling Test of FER and the 26-item Toronto Alexithymia Scale. Patients withSFD exhibited elevated alexithymia symptoms relative to healthy controls.Patients with SFD also recognized significantly fewer emotional expressions than did the healthy controls. However, the group difference in emotion recognition accuracy became nonsignificant once the influence of alexithymia was controlled for statistically. This suggests that the deficit in FER observed in the patients with SFD was most likely a consequence of concurrent alexithymia. It should be noted that neither depression nor anxiety was significantly related to emotion recognition accuracy, suggesting that these variables did not contribute the emotion recognition deficit. Impaired FER observed in the patients with SFD could plausibly have a negative influence on these individuals’ social functioning

Identifying improvements to complex pathways: evidence synthesis and stakeholder engagement in infant congenital heart disease

OBJECTIVES: Many infants die in the year following discharge from hospital after surgical or catheter intervention for congenital heart disease (3–5% of discharged infants). There is considerable variability in the provision of care and support in this period, and some families experience barriers to care. We aimed to identify ways to improve discharge and postdischarge care for this patient group. DESIGN: A systematic evidence synthesis aligned with a process of eliciting the perspectives of families and professionals from community, primary, secondary and tertiary care. SETTING: UK. RESULTS: A set of evidence-informed recommendations for improving the discharge and postdischarge care of infants following intervention for congenital heart disease was produced. These address known challenges with current care processes and, recognising current resource constraints, are targeted at patient groups based on the number of patients affected and the level and nature of their risk of adverse 1-year outcome. The recommendations include: structured discharge documentation, discharging certain high-risk patients via their local hospital, enhanced surveillance for patients with certain (high-risk) cardiac diagnoses and an early warning tool for parents and community health professionals. CONCLUSIONS: Our recommendations set out a comprehensive, system-wide approach for improving discharge and postdischarge services. This approach could be used to address challenges in delivering care for other patient populations that can fall through gaps between sectors and organisations

Under-ascertainment of Aboriginality in records of cardiovascular disease in hospital morbidity and mortality data in Western Australia: a record linkage study

<p>Abstract</p> <p>Background</p> <p>Measuring the real burden of cardiovascular disease in Australian Aboriginals is complicated by under-identification of Aboriginality in administrative health data collections. Accurate data is essential to measure Australia's progress in its efforts to intervene to improve health outcomes of Australian Aboriginals. We estimated the under-ascertainment of Aboriginal status in linked morbidity and mortality databases in patients hospitalised with cardiovascular disease.</p> <p>Methods</p> <p>Persons with public hospital admissions for cardiovascular disease in Western Australia during 2000-2005 (and their 20-year admission history) or who subsequently died were identified from linkage data. The Aboriginal status flag in all records for a given individual was variously used to determine their ethnicity (index positive, and in all records both majority positive or ever positive) and stratified by region, age and gender. The index admission was the baseline comparator.</p> <p>Results</p> <p>Index cases comprised 62,692 individuals who shared a total of 778,714 hospital admissions over 20 years, of which 19,809 subsequently died. There were 3,060 (4.9%) persons identified as Aboriginal on index admission. An additional 83 (2.7%) Aboriginal cases were identified through death records, increasing to 3.7% when cases with a positive Aboriginal identifier in the majority (≥50%) of previous hospital admissions over twenty years were added and by 20.8% when those with a positive flag in any record over 20 years were incorporated. These results equated to underestimating Aboriginal status in unlinked index admission by 2.6%, 3.5% and 17.2%, respectively. Deaths classified as Aboriginal in official records would underestimate total Aboriginal deaths by 26.8% (95% Confidence Interval 24.1 to 29.6%).</p> <p>Conclusions</p> <p>Combining Aboriginal determinations in morbidity and official death records increases ascertainment of unlinked cardiovascular morbidity in Western Australian Aboriginals. Under-identification of Aboriginal status is high in death records.</p

A Note on the Equality of Algebraic and Geometric D-Brane Charges in WZW Models

The algebraic definition of charges for symmetry-preserving D-branes in Wess-Zumino-Witten models is shown to coincide with the geometric definition, for all simple Lie groups. The charge group for such branes is computed from the ambiguities inherent in the geometric definition.Comment: 12 pages, fixed typos, added references and a couple of remark

Assessing the effectiveness of front of pack labels: Findings from an online randomised-controlled experiment in a representative British sample

Front of pack food labels (FOPLs) provide accessible nutritional information to guide consumer choice. Using an online experiment with a large representative British sample, we aimed to examine whether FOPLs improve participants’ ability to identify the healthiness of foods and drinks. The primary aim was to compare ability to rank between FOPL groups and a no label control. Adults (≥18 years), recruited from the NatCen panel, were randomised to one of five experimental groups (Multiple Traffic Light, MTL; Nutri-Score, N-S; Warning Label, WL; Positive Choice tick, PC; no label control). Stratification variables were year of recruitment to panel, sex, age, government office region, and household income. Packaging images were created for three versions, varying in healthiness, of six food and drink products (pizza, drinks, cakes, crisps, yoghurts, breakfast cereals). Participants were asked to rank the three product images in order of healthiness. Ranking was completed on a single occasion and comprised a baseline measure (with no FOPL), and a follow-up measure including the FOPL as per each participant’s experimental group. The primary outcome was the ability to accurately rank product healthiness (all products ranked correctly vs. any incorrect). In 2020, 4504 participants had complete data and were included in the analysis. The probability of correct ranking at follow-up, and improving between baseline and follow-up, was significantly greater across all products for the N-S, MTL and WL groups, compared to control. This was seen for only some of the products for the PC group. The largest effects were seen for N-S, followed by MTL. These analyses were adjusted for stratification variables, ethnicity, education, household composition, food shopping responsibility, and current FOPL use. Exploratory analyses showed a tendency for participants with higher compared to lower education to rank products more accurately. Conclusions: All FOPLs were effective at improving participants’ ability to correctly rank products according to healthiness in this large representative British sample, with the largest effects seen for N-S, followed by MTL