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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.
Informal carers play an essential role in the care of individuals with Parkinson’s disease (PD). This role, however, is often fraught with difficulties, including emotional, physical, and financial. Coping styles and relationship quality have been hypothesized to influence the impact of stressors. The aim of this study is to examine the relationship between carers’ coping style, relationship quality, and carer burden.
Thirty-nine PD patient carer dyads were included in the study.
Participants completed self-rated questionnaires including the Dyadic Adjustment Scale, Zarit Burden Interview, and Brief Coping Orientation to Problems Experienced Inventory.
Correlational analyses found significant and positive correlation between carer burden and all three coping styles (problem-focused, emotion-focused, and dysfunctional). There was also a moderate association between carers’ perceived relationship quality and satisfaction and carer burden. Regression analyses found that carer’s gender, severity of PD, relationship quality, emotion-focused, and dysfunctional coping styles did not predict carer burden. Conversely, problem-focused coping style predicted carer burden.
The results highlight that there is no perfect way to react and care for a loved one and serves as important information for practitioners who design and implement interventions.
Young people with social disability and severe and complex mental health problems have poor outcomes, frequently struggling with treatment access and engagement. Outcomes may be improved by enhancing care and providing targeted psychological or psychosocial intervention.
We aimed to test the hypothesis that adding social recovery therapy (SRT) to enhanced standard care (ESC) would improve social recovery compared with ESC alone.
A pragmatic, assessor-masked, randomised controlled trial (PRODIGY: ISRCTN47998710) was conducted in three UK centres. Participants (n = 270) were aged 16–25 years, with persistent social disability, defined as under 30 hours of structured activity per week, social impairment for at least 6 months and severe and complex mental health problems. Participants were randomised to ESC alone or SRT plus ESC. SRT was an individual psychosocial therapy delivered over 9 months. The primary outcome was time spent in structured activity 15 months post-randomisation.
We randomised 132 participants to SRT plus ESC and 138 to ESC alone. Mean weekly hours in structured activity at 15 months increased by 11.1 h for SRT plus ESC (mean 22.4, s.d. = 21.4) and 16.6 h for ESC alone (mean 27.7, s.d. = 26.5). There was no significant difference between arms; treatment effect was −4.44 (95% CI −10.19 to 1.31, P = 0.13). Missingness was consistently greater in the ESC alone arm.
We found no evidence for the superiority of SRT as an adjunct to ESC. Participants in both arms made large, clinically significant improvements on all outcomes. When providing comprehensive evidence-based standard care, there are no additional gains by providing specialised SRT. Optimising standard care to ensure targeted delivery of existing interventions may further improve outcomes.
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.
Sublabial gland biopsy is the ‘gold standard’ in establishing the diagnosis of primary Sjögren's syndrome. Bleeding and nerve damage are complications. Our centre has adopted the use of the chalazion clamp to provide a dry surgical field to address these challenges. This study aimed to assess the accuracy of minor salivary gland harvest rate using this technique.
A retrospective review of all minor salivary gland biopsies was carried out in a single tertiary referral centre over a five-year period.
Forty-one biopsy patients were identified, with a mean age of 56.1 years. There was 100 per cent accuracy in harvest rate in our series. Twelve patients (29 per cent) were positive for primary Sjögren's syndrome. No patients had a complication immediately or at one month follow up.
Dry surgical field sublabial gland biopsy is a safe and highly effective technique in the diagnosis of primary Sjögren's syndrome. Initial results indicate it may provide a higher harvest rate with fewer complications than traditional non-ischaemic techniques.
The schizophrenia polygenic risk score (SCZ-PRS) is an emerging tool in psychiatry.
We aimed to evaluate the utility of SCZ-PRS in a young, transdiagnostic, clinical cohort.
SCZ-PRSs were calculated for young people who presented to early-intervention youth mental health clinics, including 158 patients of European ancestry, 113 of whom had longitudinal outcome data. We examined associations between SCZ-PRS and diagnosis, clinical stage and functioning at initial assessment, and new-onset psychotic disorder, clinical stage transition and functional course over time in contact with services.
Compared with a control group, patients had elevated PRSs for schizophrenia, bipolar disorder and depression, but not for any non-psychiatric phenotype (for example cardiovascular disease). Higher SCZ-PRSs were elevated in participants with psychotic, bipolar, depressive, anxiety and other disorders. At initial assessment, overall SCZ-PRSs were associated with psychotic disorder (odds ratio (OR) per s.d. increase in SCZ-PRS was 1.68, 95% CI 1.08–2.59, P = 0.020), but not assignment as clinical stage 2+ (i.e. discrete, persistent or recurrent disorder) (OR = 0.90, 95% CI 0.64–1.26, P = 0.53) or functioning (R = 0.03, P = 0.76). Longitudinally, overall SCZ-PRSs were not significantly associated with new-onset psychotic disorder (OR = 0.84, 95% CI 0.34–2.03, P = 0.69), clinical stage transition (OR = 1.02, 95% CI 0.70–1.48, P = 0.92) or persistent functional impairment (OR = 0.84, 95% CI 0.52–1.38, P = 0.50).
In this preliminary study, SCZ-PRSs were associated with psychotic disorder at initial assessment in a young, transdiagnostic, clinical cohort accessing early-intervention services. Larger clinical studies are needed to further evaluate the clinical utility of SCZ-PRSs, especially among individuals with high SCZ-PRS burden.
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.
Introduction: Cases of anaphylaxis in children are often not appropriately managed by caregivers. We aimed to develop and to test the effectiveness of an education tool to help pediatric patients and their families better understand anaphylaxis and its management and to improve current knowledge and treatment guidelines adherence. Methods: The GEAR (Guidelines and Educational programs based on an Anaphylaxis Registry) is an initiative that recruits children with food-induced anaphylaxis who have visited the ED at the Montreal Children's Hospital and at The Children's Clinic located in Montreal, Quebec. The patients and parents, together, were asked to complete six questions related to the triggers, recognition and management of anaphylaxis at the time of presentation to the allergy clinic. Participants were automatically shown a 5-minute animated video addressing the main knowledge gaps related to the causes and management of anaphylaxis. At the end of the video, participants were redirected to same 6 questions to respond again. To test long-term knowledge retention, the questionnaire will be presented again in one year's time. A paired t-test was used to compare the difference between the baseline score and the follow-up score based on percentage of correct answers of the questionnaire. Results: From June to November 2019, 95 pediatric patients with diagnosed food-induced anaphylaxis were recruited. The median patient age was 4.5 years (Interquartile Range (IQR): 1.6–7.4) and half were male (51.6%). The mean questionnaire baseline score was 0.77 (77.0%, standard deviation (sd): 0.16) and the mean questionnaire follow-up score was 0.83 (83.0%, sd: 0.17). There was a significant difference between the follow-up score and baseline score (difference: 0.06, 95% CI: 0.04, 0.09). There were no associations of baseline questionnaire scores and change in scores with age and sex. Conclusion: Our video teaching method was successful in educating patients and their families to better understand anaphylaxis. The next step is to acquire long-term follow up scored to determine retention of knowledge.
To identify risk factors of patients placed in airborne infection isolation (AII) for possible pulmonary tuberculosis (TB) to better predict TB diagnosis and allow more judicious use of AII.
Case-control, retrospective study at a single tertiary-care academic medical center. The study included all adult patients admitted from October 1, 2014, through October 31, 2017, who were placed in AII for possible pulmonary TB. Cases were defined as those ultimately diagnosed with pulmonary TB. Controls were defined as those not diagnosed with pulmonary TB. Those with TB diagnosed prior to admission were excluded. In total, 662 admissions (558 patients) were included.
Overall, 15 cases of pulmonary TB were identified (2.7%); of these, 2 were people living with human immunodeficiency virus (HIV; PLWH). Statistical analysis was limited by low case number. Those diagnosed with pulmonary TB were more likely to have been born outside the United States (53% vs 13%; P < .001) and to have had prior positive TB testing, regardless of prior treatment (50% vs 19%; P = .015). A multivariate analysis using non–US birth and prior positive TB testing predicted an 18.2% probability of pulmonary TB diagnosis when present, compared with 1.0% if both factors were not present.
The low number of pulmonary TB cases indicated AII overuse, especially in PLWH, and more judicious use of AII is warranted. High-risk groups, including those born outside the United States and those with prior positive TB testing, should be considered for AII in the appropriate clinical setting.
Saunders & van Brakel argue, inter alia, that there
is “little evidence” for the claim that there are four
unique hues (red, green, blue, and yellow), and that there are two
corresponding opponent processes. We argue that this is quite
Floriculture value exceeds $5.8 billion in the United States. Environmental challenges, market trends, and diseases complicate breeding priorities. To inform breeders’ and geneticists’ research efforts, we set out to gather consumers’ preferences in the form of willingness to pay (WTP) for different rose attributes in a discrete choice experiment. The responses are modeled in WTP space, using polynomials to account for heterogeneity. Consumer preferences indicate that heat and disease tolerance were the most important aspects for subjects in the sample, followed by drought resistance. To the best of our knowledge, this is the first study to identify breeding priorities in rosaceous plants from a consumer perspective.