Involving participants in the design of clinical trials should improve the overall success of a study. For this to occur, streamlined mechanisms are needed to connect the populations potentially impacted by a given study or health topic with research teams in order to inform trial design in a meaningful and timely manner. To address this need, we developed an innovative mechanism called the “ResearchMatch Expert Advice Tool” that quickly obtains volunteer perspectives from populations with specific health conditions or lived experiences using the national recruitment registry, ResearchMatch. This tool does not ask volunteers to participate in the trial but allows for wider community feedback to be gathered and translated into actionable recommendations used to inform the study’s design. We describe early use cases that shaped the current Expert Advice Tool workflow, how results from this tool were incorporated and implemented by studies, and feedback from volunteers and study teams regarding the tool’s usefulness. Additionally, we present a set of lessons learned during the development of the Expert Advice Tool that can be used by other recruitment registries seeking to obtain volunteer feedback on study design and operations.

Food cravings are one of several important complexities between psychological and physiological triggers for food consumption. Cravings are commonly cited as contributing to over-consumption of hyperpalatable foods (sugary, salty, and fatty foods) and may be causal in obesity(1). The Mediterranean dietary pattern (MedDiet) is linked to reduced disease risk and improved health and wellbeing(2). Despite a lower intake of sugary and salty foods compared to a Western diet, free-living adults switching to the MedDiet find it satiating and achieve high adherence in Western countries. The MedDiet is known to improve mood and wellbeing, is high in fibre, monounsaturated fat and low in added sugar, and has a low glycaemic load, which could separately and synergistically reduce food cravings. The relationship between adherence to the MedDiet and food cravings has never been investigated. In the MedLey randomised controlled trial, we investigated the effects of a MedDiet on food cravings, compared with a habitual Australian diet (HabDiet)(3). Adherence to the MedDiet was scored out of 15 (maximum adherence). Participants completed three food cravings questionnaires at baseline and 6-months. The State questionnaire measures momentary cravings and has a maximum score of 75, indicating maximum food cravings. The Trait-reduced questionnaire measures general cravings and has a maximum score of score of 126, indicating more frequent and intense cravings for foods. The Food Cravings Inventory (FCI) measures cravings for four food domains: fatty foods, fast foods, sugary foods, and high carbohydrate (CHO) foods. MedDiet group (n = 58) responses were compared with the HabDiet group (n = 53) across visits using linear mixed effects modelling. Predicted differences were obtained for adherence scores of ≤8 (median adherence) and ≥9. Means ± SD or CIs are presented. Mean adherence increased from 7.1 ± 1.8 to 10.7 ± 1.48 in the MedDiet group (P<0.01), with no change in the HabDiet group (P = 1.00). Trait-reduced scores were not significantly different between groups at 6-months (P = 0.11), although there was a 5.57-point reduction within the MedDiet group (CI −12.56, −1.96, P = 0.04). State score was significantly lower in the MedDiet group than the HabDiet at 6-months (−4.4 (CI −7.53, −0.39), P = 0.03), and was significantly lower than at baseline (−5.9 (CI −9.33, −0.24,) P = 0.04). There were no differences between groups for the four domains of the FCI (P>0.05). Cravings for sugary foods was significantly reduced within the MedDiet group (−0.26 (CI −0.46, −0.05) P = 0.01). The predictive modelling suggested moving from an adherence score of 8 to 9 was associated with lower cravings for sugar (−0.03 ± 0.01, P = 0.03), fast food (−0.04 ± 0.02, P = 0.02) and CHO foods (−0.05 ± 0.02, P = 0.02). These results are suggestive that higher adherence to a MedDiet could reduce cravings compared to the Australian diet and suggest that the MedDiet may specifically reduce sugar cravings. Further investigation is warranted, through observational and intervention trials.

A total of 140 trout were examined from four lakes in north west Ireland, Loughs Craghy, Waskel, Meela and Owennamarve. Eleven species of metazoan parasite were recorded, ten of which were of freshwater origin and Anisakissp. was the only marine species. No acanthocephalan species were found. Diphyllobothrium ditremum, D. dendriticum and Anisakissp. were the only allogenic species. Lough Owennamarve had the largest component community with nine species recorded. Lough Meela, the only brackish water lake had the smallest component community with six species recorded. Lough Waskel and Craghy had intermediate component community values. Lough Meela showed the lowest levels of similarity to any of the other lakes. Values for the Shannon-Wiener diversity index were highest for Lough Owennamarve and lowest for Lough Meela and intermediate for the other two lakes. Lough Meela had the highest values for the Simpson's dominance index and the Berger-Parker index. Lough Owennamarve had the highest Brillouin's index and Lough Meela had the lowest. The use of multiple regression techniques to control for the potentially confounding effect of geographical distance as a predictor of community similarity was discussed. No parasite species found could be considered as regionally and locally abundant and therefore described as a core species. The helminth community appears to have some degree of predictability, but chance colonization events are also important.

New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.

The stressful effects that environments have on farm and laboratory animal welfare are likely to depend on how much animals understand of the behaviour and intentions of their conspecifics as well as on their understanding of their physical environment. However, studies on animal social cognition have primarily focused on primates. Here, we report on our work on social cognition in domestic pigs. It focuses on the ability of domestic pigs to assess and use to their advantage the behaviour of conspecifics, and uses approaches pioneered in studies on primates. Our work has shown that dominant pigs use the privileged knowledge of a subordinate to their own advantage in a competitive foraging situation. While such exploitative behaviour is likely to be based on rapid learning about the subordinate ‘s behaviour, it is also possible that ‘higher’ cognitive abilities such as visual perspective taking could be involved. Ongoing work uses an adaptation of the Guesser-Knower paradigm to test whether pigs are indeed capable of visual perspective taking.

In November 2019, an outbreak of Shiga toxin-producing Escherichia coli O157:H7 was detected in South Yorkshire, England. Initial investigations established consumption of milk from a local dairy as a common exposure. A sample of pasteurised milk tested the next day failed the phosphatase test, indicating contamination of the pasteurised milk by unpasteurised (raw) milk. The dairy owner agreed to immediately cease production and initiate a recall. Inspection of the pasteuriser revealed a damaged seal on the flow divert valve. Ultimately, there were 21 confirmed cases linked to the outbreak, of which 11 (52%) were female, and 12/21 (57%) were either <15 or >65 years of age. Twelve (57%) patients were treated in hospital, and three cases developed haemolytic uraemic syndrome. Although the outbreak strain was not detected in the milk samples, it was detected in faecal samples from the cattle on the farm. Outbreaks of gastrointestinal disease caused by milk pasteurisation failures are rare in the UK. However, such outbreaks are a major public health concern as, unlike unpasteurised milk, pasteurised milk is marketed as ‘safe to drink’ and sold to a larger, and more dispersed, population. The rapid, co-ordinated multi-agency investigation initiated in response to this outbreak undoubtedly prevented further cases.

Clinical trials continue to face significant challenges in participant recruitment and retention. The Recruitment Innovation Center (RIC), part of the Trial Innovation Network (TIN), has been funded by the National Center for Advancing Translational Sciences of the National Institutes of Health to develop innovative strategies and technologies to enhance participant engagement in all stages of multicenter clinical trials. In collaboration with investigator teams and liaisons at Clinical and Translational Science Award institutions, the RIC is charged with the mission to design, field-test, and refine novel resources in the context of individual clinical trials. These innovations are disseminated via newsletters, publications, a virtual toolbox on the TIN website, and RIC-hosted collaboration webinars. The RIC has designed, implemented, and promised customized recruitment support for 173 studies across many diverse disease areas. This support has incorporated site feasibility assessments, community input sessions, recruitment materials recommendations, social media campaigns, and an array of study-specific suggestions. The RIC’s goal is to evaluate the efficacy of these resources and provide access to all investigating teams, so that more trials can be completed on time, within budget, with diverse participation, and with enough accrual to power statistical analyses and make substantive contributions to the advancement of healthcare.

In October 2019, public health surveillance systems in Scotland identified an increase in the number of reported infections of Shiga toxin-producing Escherichia coli (STEC) O26:H11 involving bloody diarrhoea. Ultimately, across the United Kingdom (UK) 32 cases of STEC O26:H11 stx1a were identified, with the median age of 27 years and 64% were male; six cases were hospitalised. Among food exposures there was an association with consuming pre-packed sandwiches purchased at outlets belonging to a national food chain franchise (food outlet A) [odds ratio (OR) = 183.89, P < 0.001]. The common ingredient identified as a component of the majority of the sandwiches sold at food outlet A was a mixed salad of Apollo and Iceberg lettuce and spinach leaves. Microbiological testing of food and environmental samples were negative for STEC O26:H11, although STEC O36:H19 was isolated from a mixed salad sample taken from premises owned by food outlet A. Contamination of fresh produce is often due to a transient event and detection of the aetiological agent in food that has a short-shelf life is challenging. Robust, statistically significant epidemiological analysis should be sufficient evidence to direct timely and targeted on-farm investigations. A shift in focus from testing the microbiological quality of the produce to investigating the processes and practices through the supply chain and sampling the farm environment is recommended.

Biogenic nanoscale vanadium magnetite is produced by converting V(V)-bearing ferrihydrites through reductive transformation using the metal-reducing bacterium Geobacter sulfurreducens. With increasing vanadium in the ferrihydrite, the amount of V-doped magnetite produced decreased due to V-toxicity which interrupted the reduction pathway ferrihydrite–magnetite, resulting in siderite or goethite formation. Fe L2,3 and V L2,3 X-ray absorption spectra and data from X-ray magnetic circular dichroism analysis revealed the magnetite to contain the V in the Fe(III) Oh site, predominately as V(III) but always with a component of V(VI), present a consistent V(IV)/V(III) ratio in the range 0.28 to 0.33. The bacteriogenic production of V-doped magnetite nanoparticles from V-doped ferrihydrite is confirmed and the work reveals that microbial reduction of contaminant V(V) to V(III)/V(IV) in the environment will occur below the Fe-redox boundary where it will be immobilised in biomagnetite nanoparticles.

Nick Martin is a pioneer in recognizing the need for large sample size to study the complex, heterogeneous and polygenic disorders of common mental disorders. In the predigital era, questionnaires were mailed to thousands of twin pairs around Australia. Always quick to adopt new technology, Nick’s studies progressed to phone interviews and then online. Moreover, Nick was early to recognize the value of collecting DNA samples. As genotyping technologies improved over the years, these twin and family cohorts were used for linkage, candidate gene and genome-wide association studies. These cohorts have underpinned many analyses to disentangle the complex web of genetic and lifestyle factors associated with mental health. With characteristic foresight, Nick is chief investigator of our Australian Genetics of Depression Study, which has recruited 16,000 people with self-reported depression (plus DNA samples) over a time frame of a few months — analyses are currently ongoing. The mantra of sample size, sample size, sample size has guided Nick’s research over the last 30 years and continues to do so.