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OBJECTIVES/GOALS: Six CTSA sites formed a collaboration to DEVELOP, DEMONSTRATE, AND DISSEMINATE new infrastructure to streamline collection and analysis of research participant feedback, using the Research Participant Perception Survey (RPPS), common standards, and customized REDCap-based tools, to improve the clinical research enterprise. METHODS/STUDY POPULATION: DEVELOP charter, consensus approach, core survey, deployment standards, data-use agreements; define meta-data, system requirements for the infrastructure, use-cases. Engage stakeholders for broad institutional and community input. Build RPPS/REDCap project, visual analytics Dashboard External Module, and Program Dashboard module for evaluation. Configure to use with Multilingual Module. DEMONSTRATE by implementing site-based use cases that reflect local priorities and span diverse populations, testing different methods of survey deployment (REDCap, patient portal, SMS) to showcase utility and flexibility. Generate data for local and inter-institutional benchmarking. Refine, then DISSEMINATE new infrastructure across the Consortium and REDCap community for broader testing and uptake. RESULTS/ANTICIPATED RESULTS: The project team refined the RPPS survey for inclusivity and mode of informed consent; defined standards for survey timing, sampling, and study metadata; configured the data dictionary in English and Spanishfor use with the multi-lingual module ; developed tools for project evaluation. Stakeholder engagement identified themes of anticipated value and fears about feedback. We designed an At-a-Glance Dashboard to display survey results with detailed analytics and filters. A REDCap application programming interface will send de-identified site data to the EPV Consortium Database to support benchmarking. Full implementation began November 2021 and will scale in 2022. Dissemination to Consortium and REDCap users is ongoing through presentations and a project website (www.Rockefeller.edu/research/epv). DISCUSSION/SIGNIFICANCE: Direct feedback from representative populations about their experiences in research is essential to understand and resolve barriers to broad participation in research. Streamlined RPPS/REDCap infrastructure provides a platform for local and national benchmarking, and collection of actionable data to improve clinical research.
There are many structural problems facing the UK at present, from a weakened National Health Service to deeply ingrained inequality. These challenges extend through society to clinical practice and have an impact on current mental health research, which was in a perilous state even before the coronavirus pandemic hit. In this editorial, a group of psychiatric researchers who currently sit on the Academic Faculty of the Royal College of Psychiatrists and represent the breadth of research in mental health from across the UK discuss the challenges faced in academic mental health research. They reflect on the need for additional investment in the specialty and ask whether this is a turning point for the future of mental health research.
Little is known about mental health problems of children and young people (CYP) involved with public and private law family court proceedings, and how these CYP fare compared to those not involved in these significant disruptions to family life.
This study examined records of depression/anxiety in CYP involved in public and private law proceedings using linked population-level data across Wales.
Retrospective e-cohort study. We calculated the incidence of primary-care-recorded depression/anxiety among CYP involved in these proceedings and in a comparison group, using Poisson regression. Depression/anxiety outcomes following proceedings were evaluated using pairwise Cox regression, with age- and gender-matched controls of CYP who had no involvement with the courts.
CYP in the public group had twice the risk of depression (adjusted incidence rate ratio aIRR = 2.2; 95% CI 1.9–2.6) and 20% higher risk of anxiety (aIRR = 1.2; 95% CI 1.0–1.5) relative to the comparison group. The private group had 60% higher risk of depression (aIRR = 1.6; 95% CI 1.4–1.7) and 30% higher risk of anxiety (aIRR = 1.3; 95% CI 1.2–1.4). Following private law proceedings, CYP were more likely to have depression (hazard ratio HR = 1.9; 95% CI 1.7–2.1), and anxiety (HR = 1.4; 95% CI 1.2–1.6) than the control group. Following public proceedings, CYP were more likely to have depression (HR = 2.1; 95% CI 1.7–2.5). Incidence of anxiety or depression following court proceedings was around 4%.
Findings highlight the vulnerability of CYP involved in family court proceedings and increased risk of depression and anxiety. Schools, health professionals, social and family support workers have a role to play in identifying needs and ensuring CYP receive appropriate support before, during and after proceedings.
The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network’s single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.
The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. International Review Board (IRB) offices developed plans to rapidly review protocols related to the COVID-19 pandemic. An online survey was conducted with the IRB Directors at Clinical and Translational Science Awards (CTSA) institutions as well as two focus groups. Across the CTSA institutions, 66% reviewed COVID-19 protocols across all their IRB committees, 22% assigned protocols to just one committee, and 10% created a new committee for COVID-19 protocols. Fifty-two percent reported COVID-19 protocols were reviewed much faster, 41% somewhat faster, and 7% at the same speed as other protocols. Three percent reported that the COVID-19 protocols were reviewed with much better quality, 32% reported slightly better quality, and 65% reported the reviews were of the same quality as similar protocols before the COVID-19 pandemic. IRBs were able to respond to the emergent demand for reviewing COVID-19 protocols. Most of the increased review capacity was due to extra effort by IRB staff and members and not changes that will be easily implemented across all research going forward.
Longitudinal studies of patterns of healthcare contacts in those who die by suicide to identify those at risk are scarce.
To examine type and timing of healthcare contacts in those who die by suicide.
A population-based electronic case–control study of all who died by suicide in Wales, 2001–2017, linking individuals’ electronic healthcare records from general practices, emergency departments and hospitals. We used conditional logistic regression to calculate odds ratios, adjusted for deprivation. We performed a retrospective continuous longitudinal analysis comparing cases’ and controls’ contacts with health services.
We matched 5130 cases with 25 650 controls (5 per case). A representative cohort of 1721 cases (8605 controls) were eligible for the fully linked analysis. In the week before their death, 31.4% of cases and 15.6% of controls contacted health services. The last point of contact was most commonly associated with mental health and most often occurred in general practices. In the month before their death, 16.6 and 13.0% of cases had an emergency department contact and a hospital admission respectively, compared with 5.5 and 4.2% of controls. At any week in the year before their death, cases were more likely to contact healthcare services than controls. Self-harm, mental health and substance misuse contacts were strongly linked with suicide risk, more so when they occurred in emergency departments or as emergency admissions.
Help-seeking occurs in those at risk of suicide and escalates in the weeks before their death. There is an opportunity to identify and intervene through these contacts.
Catheter-associated urinary tract infections (CAUTIs) occur frequently in pediatric inpatients, and they are associated with increased morbidity and cost. Few studies have investigated ambulatory CAUTIs, despite at-risk children utilizing home urinary catheterization. This retrospective cohort and case-control study determined incidence, risk factors, and outcomes of pediatric patients with ambulatory CAUTI.
Broad electronic queries identified potential patients with ambulatory urinary catheters, and direct chart review confirmed catheters and adjudicated whether ambulatory CAUTI occurred. CAUTI definitions included clean intermittent catheterization (CIC). Our matched case-control analysis assessed risk factors.
Five urban, academic medical centers, part of the New York City Clinical Data Research Network.
Potential patients were age <22 years who were seen between October 2010 and September 2015.
In total, 3,598 eligible patients were identified; 359 of these used ambulatory catheterization (representing186,616 ambulatory catheter days). Of these, 63 patients (18%) experienced 95 ambulatory CAUTIs. The overall ambulatory CAUTI incidence was 0.51 infections per 1,000 catheter days (1.35 for indwelling catheters and 0.47 for CIC; incidence rate ratio, 2.88). Patients with nonprivate medical insurance (odds ratio, 2.5; 95% confidence interval, 1.1–6.3) were significantly more likely to have ambulatory CAUTIs in bivariate models but not multivariable models. Also, 45% of ambulatory CAUTI resulted in hospitalization (median duration, 3 days); 5% resulted in intensive care admission; 47% underwent imaging; and 88% were treated with antibiotics.
Pediatric ambulatory CAUTIs occur in 18% of patients with catheters; they are associated with morbidity and healthcare utilization. Ambulatory indwelling catheter CAUTI incidence exceeded national inpatient incidence. Future quality improvement research to reduce these harmful infections is warranted.
Patients who experience Transient Ischaemic Attack (TIA) should be assessed and treated in a specialist clinic to reduce risk of further TIA or stroke. But referrals are often delayed. We aimed to identify published studies describing pathways for emergency assessment and referral of patients with suspected TIA at first medical contact: primary care; ambulance services; and emergency department.
We conducted a scoping literature review. We searched four databases (PubMed, CINAHL, Web of Science, Scopus). We screened studies for eligibility. We extracted and analysed data to describe setting, assessment and referral processes reported in primary research on referral of suspected TIA patients directly to specialist outpatient services.
We identified eight studies in nine papers from five countries: 1/9 randomized trial; 6/9 before-and-after designs; 2/9 descriptive account. Five pathways were used by family doctors and three by Emergency Department (ED) physicians. None were used by paramedics. Clinicians identified TIA patients using a checklist incorporating the ABCD2 tool to describe risk of further stroke, online decision support tool or clinical judgement. They referred to a specialist clinic, either directly or via a telephone helpline. Anti-platelet medication was often given, usually aspirin unless contraindicated. Some patients underwent neurological and blood tests before referral and discharge. Five studies reported reduced incident of stroke at 90 days, from 6–10 percent predicted rate to 1.2-2.1 percent actual rate. Between 44 percent and 83 percent of suspected TIA cases in these studies were directly referred to stroke clinics through the pathways.
Research literature has focused on assessment and referral by family doctors and ED physicians to reduce hospitalization of TIA patients. No pathways for paramedic use were reported. Since many suspected TIA patients present to ambulance services, effective pre-hospital assessment and referral pathways are needed. We will use review results to develop a paramedic referral pathway to test in a feasibility trial.
Adequate pain relief at the scene of injury and during transport to hospital is a major challenge in all acute traumas, especially for those with hip fractures, whose injuries are difficult to immobilize and long-term outcomes may be adversely affected by administration of opiate analgesics. Fascia Iliaca Compartment Block (FICB) is a procedure routinely undertaken by clinicians in emergency departments for hip fracture patients, but use by paramedics at the scene of emergency calls, is not yet evaluated (1).
We undertook a randomized controlled feasibility trial using novel audited scratchcard randomization to allocate eligible patients to FICB or usual care. Paramedics are recruited and trained to assess patients for hip fracture and carry out FICB. We will follow up patients to assess accuracy of paramedic diagnosis, acceptability to patients and paramedics, compliance of paramedics and also measures of pain, side effects, time in hospital and quality of life in order to plan a full trial if appropriate. The primary outcome measure is health related quality of life, measured using Short Form (SF)-12 at 1 and 6 months. Interviews and focus groups will be used to understand acceptability of FICB to patients and paramedics. This study was funded by Health and Care Research Wales (1003).
We have developed:
• paramedic pathway to assess patients for hip fracture and FICB
• paramedic training package, delivered by Consultant Anaesthetist
• randomization scratchcards.
To date we have recruited nineteen paramedics; ten are fully trained and recruiting patients, the remainder are being trained. Fifty-four patients have been randomized and thirty-five have consented to follow-up. Thirteen 1-month and five 6-month follow-up questionnaires have been received.
This study will enable us to recommend whether to undertake a definitive multi-centre randomized controlled trial of FICB by paramedics for hip fracture to determine if the procedure is effective for patients and worthwhile for the National Health Service.
Transient Ischaemic Attack (TIA) is a neurologic event with symptom resolution within 24 hours. Early specialist assessment of TIA reduces risk of stroke and death. National United Kingdom (UK) guidelines recommend patients with TIA are seen in specialist clinics within 24 hours (high risk) or seven days (low risk).
We aimed to develop a complex intervention for patients with low risk TIA presenting to the emergency ambulance service. The intervention is being tested in the TIER feasibility trial, in line with Medical Research Council (MRC) guidance on staged development and evaluation of complex interventions.
We conducted three interrelated activities to produce the TIER intervention:
• Survey of UK Ambulance Services (n = 13) to gather information about TIA pathways already in use
• Scoping review of literature describing prehospital care of patients with TIA
• Synthesis of data and definition of intervention by specialist panel of: paramedics; Emergency Department (ED) and stroke consultants; service users; ambulance service managers.
The panel used results to define the TIER intervention, to include:
1. Protocol for paramedics to assess patients presenting with TIA and identify and refer low risk patients for prompt (< 7day) specialist review at TIA clinic
2. Patient Group Directive and information pack to allow paramedic administration of aspirin to patients left at home with referral to TIA clinic
3. Referral process via ambulance control room
4. Training package for paramedics
5. Agreement with TIA clinic service provider including rapid review of referred patients
We followed MRC guidance to develop a clinical intervention for assessment and referral of low risk TIA patients attended by emergency ambulance paramedic. We are testing feasibility of implementing and evaluating this intervention in the TIER feasibility trial which may lead to fully powered multicentre randomized controlled trial (RCT) if predefined progression criteria are met.
Diets rich in fruits and vegetables (FV), which contain (poly)phenols, protect against age-related inflammation and chronic diseases. T-lymphocytes contribute to systemic cytokine production and are modulated by FV intake. Little is known about the relative potency of different (poly)phenols in modulating cytokine release by lymphocytes. We compared thirty-one (poly)phenols and six (poly)phenol mixtures for effects on pro-inflammatory cytokine release by Jurkat T-lymphocytes. Test compounds were incubated with Jurkat cells for 48 h at 1 and 30 µm, with or without phorbol ester treatment at 24 h to induce cytokine release. Three test compounds that reduced cytokine release were further incubated with primary lymphocytes at 0·2 and 1 µm for 24 h, with lipopolysaccharide added at 5 h. Cytokine release was measured, and generation of H2O2 by test compounds was determined to assess any potential correlations with cytokine release. A number of (poly)phenols significantly altered cytokine release from Jurkat cells (P<0·05), but H2O2 generation did not correlate with cytokine release. Resveratrol, isorhamnetin, curcumin, vanillic acid and specific (poly)phenol mixtures reduced pro-inflammatory cytokine release from T-lymphocytes, and there was evidence for interaction between (poly)phenols to further modulate cytokine release. The release of interferon-γ induced protein 10 by primary lymphocytes was significantly reduced following treatment with 1 µm isorhamnetin (P<0·05). These results suggest that (poly)phenols derived from onions, turmeric, red grapes, green tea and açai berries may help reduce the release of pro-inflammatory mediators in people at risk of chronic inflammation.
Over 40 years of archaeological investigations along the south coast of Papua New Guinea has identified a rapid succession of cultural changes during the late Holocene. The so-called ‘Papuan Hiccup’ (c. 1200–800 cal bp) is a poorly understood period of socio-economic upheaval along the coast, identified mainly from changes in archaeological ceramic styles and settlement patterns. During this period, the region-wide Early Papuan Pottery (EPP) tradition diverges into separate, localised ceramic sequences that have generic associations with local ethnographic wares. A correspondence between the timing of the Papuan Hiccup and a period of peak El Niño-Southern Oscillation (ENSO) activity implies a link between cultural and climate change. This paper explores this relationship further by examining changes in interaction networks along the south coast of Papua New Guinea, specifically focusing on chert artefacts. Chemical characterisation (portable X-Ray Fluorescence; pXRF) and technological analysis are used to map changes in lithic technology over time, including access to raw materials and technological organisation, at the site of Taurama, a prehistoric coastal village site that was occupied both prior to and after the Papuan Hiccup. Although the sample sizes are small and the interpretations necessarily circumscribed, it is argued that changes in the number of chert sources being exploited and in the intensity of core reduction at Taurama may be related to climate change in the region.
Acute psychological stress is positively associated with a cold/flu. The present randomised, double-blind, placebo-controlled study examined the effect of three potentially probiotic bacteria on the proportion of healthy days over a 6-week period in academically stressed undergraduate students (n 581) who received Lactobacillus helveticus R0052, Bifidobacterium longum ssp. infantis R0033, Bifidobacterium bifidum R0071 or placebo. On each day, participants recorded the intensity (scale: 0 = not experiencing to 3 = very intense) for nine cold/flu symptoms, and a sum of symptom intensity >6 was designated as a day of cold/flu. B. bifidum resulted in a greater proportion of healthy days than placebo (P≤ 0·05). The percentage of participants reporting ≥ 1 d of cold/flu during the 6-week intervention period was significantly lower with B. bifidum than with placebo (P< 0·05). There were no effects of B. infantis or L. helveticus compared with placebo on either outcome. A predictive model accounted for influential characteristics and their interactions on daily reporting of cold/flu episodes. The proportion of participants reporting a cold on any given day was lower at weeks 2 and 3 with B. bifidum and B. infantis than with placebo for the average level of stress and the most commonly reported number of hours of sleep. Daily intake of bifidobacteria provides benefit related to cold/flu outcomes during acute stress.
Many viral infections that cause minor illness in younger adults can lead to significant mortality and morbidity in older people, particularly as co-morbidities tend to accumulate with increased age. Respiratory and gastrointestinal viruses are ubiquitous and frequently cause outbreaks, with major impact on those in care homes or residential accommodation. Advances in medicine have opened the way for increased impact of the herpes viruses (varicella zoster virus, herpes simplex virus, Epstein–Barr virus and cytomegalovirus), as immune systems are manipulated. People are also leading more active lives in older age; human immunodeficiency virus (HIV) will be increasingly prevalent, as those living with HIV grow older in good health. In addition, new diagnoses of HIV, viral hepatitis and travel-related infections will present to those working in health care of older people. This review article of viral infections aims to highlight relevant pathology, with specific reference to management in older people.