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Precision or “Personalized Medicine” and “Big Data” are growing trends in the biomedical research community and highlight an increased focus on access to larger datasets to effectively explore disease processes at the molecular level versus the previously common one-size-fits all approach. This focus necessitated a local transition from independent lab and siloed projects to a single software application utilizing a common ontology to create access to data from multiple repositories. Use of a common system has allowed for increased ease of collaboration and access to quality biospecimens that are extensively annotated with clinical, molecular, and patient associated data. The software needed to function at an enterprise level while continuing to allow investigators the autonomy and security access they desire. To identify a solution, a working group comprised of representation from independent repositories and areas of research focus across departments was established and responsible for review and implementation of an enterprise-wide biospecimen management system. Central to this process was the creation of a unified vocabulary across all repositories, including consensus around source of truth, standardized field definitions, and shared terminology.
Digital Mental Health Interventions (DMHIs) that meet the definition of a medical device are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA uses procedures that were originally developed for pharmaceuticals to assess the safety of DMHIs. There is recognition that this may not be ideal, as is evident by an ongoing consultation for reform led by the MHRA and the National Institute for Health and Care Excellence.
Aims
The aim of this study was to generate an experts’ consensus on how the medical regulatory method used for assessing safety could best be adapted for DMHIs.
Method
An online Delphi study containing three rounds was conducted with an international panel of 20 experts with experience/knowledge in the field of UK digital mental health.
Results
Sixty-four items were generated, of which 41 achieved consensus (64%). Consensus emerged around ten recommendations, falling into five main themes: Enhancing the quality of adverse events data in DMHIs; Re-defining serious adverse events for DMHIs; Reassessing short-term symptom deterioration in psychological interventions as a therapeutic risk; Maximising the benefit of the Yellow Card Scheme; and Developing a harmonised approach for assessing the safety of psychological interventions in general.
Conclusion
The implementation of the recommendations provided by this consensus could improve the assessment of safety of DMHIs, making them more effective in detecting and mitigating risk.
The Interdisciplinary Home-bAsed Reablement Program (I-HARP) integrates evidence-based rehabilitation strategies into a dementia-specific person-centred, time-limited, home-based, interdisciplinary rehabilitation package. I-HARP was a 4-month model of care, incorporated into community aged care services and hospital-based community geriatric services. I-HARP involved: 8-10 individually tailored home visits by occupational therapist and registered nurse; 2-4 optional other allied health sessions; up to A$1,000 minor home modifications and/or assistive devices; and three individual carer support sessions. The aim of the study was to determine the effectiveness of I-HARP on the health and wellbeing of people living with dementia and their family carers.
Methods:
A multi-centre pragmatic parallel-arm randomised controlled trial compared I-HARP to usual care in community-dwelling people with mild to moderate dementia and family carers in Sydney, Australia (2018-22). Assessments of the client’s daily activities, mobility and health-related quality of life, caregiver burden and quality of life were conducted at baseline, 4- and 12-month follow-up. Changes from baseline were compared between groups.
Results:
Of 260 recruited, 232 (116 dyads of clients and their carers, 58 dyads per group) completed the trial to 4-month follow-up (89% retention). Clients were: aged 60-97 years, 63% female, 57% with mild dementia and 43% with moderate dementia. The I-HARP group had somewhat better mean results for most outcome measures than usual care at both 4 and 12 months, but the only statistically significant difference was a reduction in home environment hazards at 4 months (reduction: 2.29 on Home Safety Self-Assessment Tool, 95% CI: 0.52, 4.08; p=.01, effect size [ES] 0.53). Post-hoc sub-group analysis of 66 clients with mild dementia found significantly better functional independence in the intervention group: 11.2 on Disability Assessment for Dementia (95% CI: 3.4, 19.1; p=.005; ES 0.69) at 4 months and 13.7 (95% CI: 3.7, 23.7; p=.007; ES 0.69) at 12 months.
Conclusion:
The I-HARP model enhanced functional independence of people with mild dementia only but not significantly in people with moderate dementia, so did not result in better outcomes in the group overall. A different type of rehabilitation model or strategies may be required as dementia becomes more severe.
Monoclonal antibody (mAb) treatment for coronavirus disease 2019 (COVID-19) has been underutilized due to logistical challenges, lack of access, and variable treatment awareness among patients and health-care professionals. The use of telehealth during the pandemic provides an opportunity to increase access to COVID-19 care.
Methods:
This is a single-center descriptive study of telehealth-based patient self-referral for mAb therapy between March 1, 2021, and October 31, 2021, at Baltimore Convention Center Field Hospital (BCCFH).
Results:
Among the 1001 self-referral patients, the mean age was 47, and most were female (57%). White (66%), and had a primary care provider (PCP) (62%). During the study period, self-referrals increased from 14/mo in March to 427 in October resulting in a 30-fold increase. Approximately 57% of self-referred patients received a telehealth visit, and of those 82% of patients received mAb infusion therapy. The median time from self-referral to onsite infusion was 2 d (1-3 IQR).
Discussion:
Our study shows the integration of telehealth with a self-referral process improved access to mAb infusion. A high proportion of self-referrals were appropriate and led to timely treatment. This approach helped those without traditional avenues for care and avoided potential delay for patients seeking referral from their PCPs.
Environmental politics offers a useful entry point to evaluate the stability and fragility of Russia’s post-Soviet political and economic regime. The politics of the environment in Russia intersects and interacts with a range of other issues – the state’s capacity to enforce its laws; democracy and the ability of citizens to participate in politics; sources of economic growth and the regulation of the economy; inequality; and the diverse cultures of Russia’s multinational society. Russia boasts tremendous ecological diversity and significant protected natural areas, but also faces a number of environmental challenges, not least of which are the effects of climate change. In the post-Soviet period, in an effort to recover from the instabilities of the 1990s, the Putin government developed an economic model based on natural resource exploitation and an increasingly authoritarian form of governance, justifying this system as a means of achieving prosperity and economic security for citizens. Today we see that Russia has strong environmental laws that are not always well enforced. Russians express a high level of concern about environmental issues, but the political climate is increasingly hostile to activism. Russia is also making a big bet on the Arctic region where natural resource extraction is expected to bolster Russia’s future economic prospects and status as a great power, even as climate change and source of environmental degradation threaten Arctic inhabitants, wildlife, and ecosystems.
Assessing the impacts of invasive predators on the demography and distribution of native species is critical for understanding mechanisms of species persistence and informing the design of recovery programmes. On the oceanic island of Guam, the introduction of the predatory brown treesnake Boiga irregularis after World War II caused the near-total loss of the native forest avifauna. Localised snake control measures have been implemented since the early 1990s, yet it remains poorly understood how they have impacted Guam’s remaining native bird populations. To address this question, we combined intensive area searches of Andersen Air Force Base (AAFB) with island-wide transect surveys and opportunistic sightings to provide a comprehensive update on the distribution and abundance of Såli (Micronesian Starling, Aplonis opaca) – one of Guam’s last extant native bird species. Area searches of AAFB, where the largest remnant of the Såli population persists, revealed a 15-fold population increase since the last survey in the early 1990s, and transect surveys and opportunistic sightings indicate incipient recolonisation of other urbanised areas of northern and central Guam. We estimate the current island-wide population size at ~1,400 individuals. The population increase can likely be attributed to a combination of snake control measures and the Såli’s ability to exploit urban refugia for nesting and roosting. Although these trends demonstrate some population recovery, a skewed age ratio (>90% adults and subadults) at AAFB and a highly urbanised distribution and low abundance outside AAFB indicate that snake predation continues to strongly impact the population. More intensive snake suppression efforts, particularly in forested areas, may allow for the Såli population to attain its former distribution and abundance on Guam. More broadly, our findings reinforce the importance of urban areas as refugia for some threatened species.
Strengthening health systems and maintaining essential service delivery during health emergencies response is critical for early detection and diagnosis, prompt treatment, and effective control of pandemics, including the novel coronavirus disease 2019 (COVID-19). Health information systems (HIS) developed during recent Ebola outbreaks in West Africa and the Democratic Republic of the Congo (DRC) provided opportunities to collect, analyze, and distribute data to inform both day-to-day and long-term policy decisions on outbreak preparedness. As COVID-19 continues to sweep across the globe, HIS and related technological advancements remain vital for effective and sustained data sharing, contact tracing, mapping and monitoring, community risk sensitization and engagement, preventive education, and timely preparedness and response activities. In reviewing literature of how HIS could have further supported mitigation of these Ebola outbreaks and the ongoing COVID-19 pandemic, 3 key areas were identified: governance and coordination, health systems infrastructure and resources, and community engagement. In this concept study, we outline scalable HIS lessons from recent Ebola outbreaks and early COVID-19 responses along these 3 domains, synthesizing recommendations to offer clear, evidence-based approaches on how to leverage HIS to strengthen the current pandemic response and foster community health systems resilience moving forward.
In March 2017, the New Jersey Department of Health received reports of 3 patients who developed septic arthritis after receiving intra-articular injections for osteoarthritis knee pain at the same private outpatient facility in New Jersey. The risk of septic arthritis resulting from intra-articular injection is low. However, outbreaks of septic arthritis associated with unsafe injection practices in outpatient settings have been reported.
Methods:
An infection prevention assessment of the implicated facility’s practices was conducted because of the ongoing risk to public health. The assessment included an environmental inspection of the facility, staff interviews, infection prevention practice observations, and a medical record and office document review. A call for cases was disseminated to healthcare providers in New Jersey to identify patients treated at the facility who developed septic arthritis after receiving intra-articular injections.
Results:
We identified 41 patients with septic arthritis associated with intra-articular injections. Cultures of synovial fluid or tissue from 15 of these 41 case patients (37%) recovered bacteria consistent with oral flora. The infection prevention assessment of facility practices identified multiple breaches of recommended infection prevention practices, including inadequate hand hygiene, unsafe injection practices, and poor cleaning and disinfection practices. No additional cases were identified after infection prevention recommendations were implemented by the facility.
Discussion:
Aseptic technique is imperative when handling, preparing, and administering injectable medications to prevent microbial contamination.
Conclusions:
This investigation highlights the importance of adhering to infection prevention recommendations. All healthcare personnel who prepare, handle, and administer injectable medications should be trained in infection prevention and safe injection practices.
Hypoalbuminemia is associated with morbidity and mortality in critically ill children. In this multi-centre retrospective study, we aimed to determine normative values of serum albumin in neonates and infants with congenital heart disease, evaluate perioperative changes in albumin levels, and determine if low serum albumin influences post-operative outcomes. Consecutive eligible neonates and infants who underwent cardiac surgery with cardiopulmonary bypass at one of three medical centres, January 2012–August 2013, were included. Data on serum albumin levels from five data points (pre-operative, 0–24, 24–48, 48–72, 72 hours post-operative) were collected. Median pre-operative serum albumin level was 2.5 g/dl (IQR, 2.1–2.8) in neonates versus 4 g/dl (IQR, 3.5–4.4) in infants. Hypoalbuminemia was defined as <25th percentile of these values. A total of 203 patients (126 neonates, 77 infants) were included in the study. Post-operative hypoalbuminemia developed in 12% of neonates and 20% of infants; 97% occurred in the first 48 hours. In multivariable analysis, perioperative hypoalbuminemia was not independently associated with any post-operative morbidity. However, when analysed as a continuous variable, lower serum albumin levels were associated with increased post-operative morbidity. Pre-operative low serum albumin level was independently associated with increased odds of post-operative hypoalbuminemia (OR, 3.67; 95% CI, 1.01–13.29) and prolonged length of hospital stay (RR, 1.40; 95% CI, 1.08–1.82). Lower 0–24-hour post-operative serum albumin level was independently associated with an increased duration of mechanical ventilation (RR, 1.35; 95% CI, 1.12–1.64). Future studies should further assess hypoalbuminemia in this population, with emphasis on evaluating clinically meaningful cut-offs and possibly the use of serum albumin levels in perioperative risk stratification models.
Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons (MIC). We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.
The officers of arms [kings of arms, heralds and pursuivants] have often been overlooked by scholars of late medieval elite society. Yet as officers of the crown, ducal courts or noble families, they played important parts in a number of areas. They were crucial to foreign and domestic relations, and chivalric culture; and, of course, they were to become the powerbrokers of heraldic symbols and genealogy. However, despite the high levels at which they operated, their roles in these areas remain largely unexplored, with scholarship tending to focus on the science of heraldry rather than the heralds themselves. This collection aims to remedy that neglect. The contributions cover a range of European regions [particularly Florence, Scandinavia, Poland, the German Empire, the Burgundian Low Countries, Brittany, Scotland and England] and discuss the diverse roles and experiences of heralds in the late Middle Ages.
Contributors: JACKSON W. ARMSTRONG, ADRIAN AILES, KATIE STEVENSON, MICHAEL JONES, FRANCK VILTART, HENRI SIMMONEAU, WIM VAN ANROOIJ, BOGDAN WOJCIECH BRZUSTOWICZ, ALEXIA GROSJEAN, LAURA CIRRI
Hurricane Sandy hit the East Coast of the United States on 29 October 2012, flooding hundreds of thousands of homes and costing over $50 billion in property damage. After Hurricane Sandy residents and communities required food, water and clothing, and in the weeks and months following, there was demand for cleaning supplies, building materials and contracting services. Polycentric orders, because of their flexibility and access to local knowledge, are well suited to respond to the challenges of disaster. We highlight the importance of privately provided social services within polycentric orders and illustrate that the private provision of these services was important to post-disaster recovery in the Orthodox Jewish community in the Rockaway Peninsula in New York.
No study systematically has investigated the supportive care needs of general head and neck cancer patients using validated measures. These needs include physical and daily living needs, health system and information needs, patient care and support needs, psychological needs, and sexuality needs. Identifying the unmet needs of head and neck cancer patients is a necessary first step to improving the care we provide to patients seen in our head and neck oncology clinics. It is recommended as the first step in intervention development in the Pan-Canadian Clinical Practice Guideline of the Canadian Partnership Against Cancer (see Howell, 2009). This study aimed to identify: (1) met and unmet supportive care needs of head and neck cancer patients, and (2) variability in needs according to demographics, disease variables, level of distress, and quality-of-life domains.
Methods:
Participants were recruited from the otolaryngology–head and neck surgery clinics of two university teaching hospitals. Self-administered questionnaires included sociodemographic and medical questions, as well as validated measures such as the Supportive Care Needs Survey–Short Form (SCNS-SF34), the Hospital Anxiety and Depression Scale (HADS), and the Functional Assessment of Cancer Therapy–General (FACT-G) and Head and Neck Module (FACT-H&N) (quality of life measures).
Results:
One hundred and twenty-seven patients participated in the survey. 68% of them experienced unmet needs, and 25% revealed a clinically significant distress level on the HADS. The highest unmet needs were psychological (7 of top 10 needs). A multiple linear regression indicated a higher level of overall unmet needs when patients were divorced, had a high level of anxiety (HADS subscale), were in poor physical condition, or had a diminished emotional quality of life (FACT-G subscales).
Significance of results:
The results of this study highlight the overwhelming presence of unmet psychological needs in head and neck cancer patients and underline the importance of implementing interventions to address these areas perceived by patients as important. In line with hospital resource allocation and cost-effectiveness, one may also contemplate screening patients for high levels of anxiety, as well as target patients who are divorced and present low levels of physical well-being, as these patients may have more overall needs to be met.
Background: Most people with dementia in Western societies will eventually be placed in a nursing home. This can be stressful to those with dementia and to their families. The adjustment to this new caring environment by both residents and their family caregivers and the factors that influence this are the focus of this review.
Methods: A literature search of Embase, Scopus, and Medline databases of articles published in English between 1990 and 2011 using specified search terms was performed to examine this transition. The 174 titles located were screened and reference lists hand searched resulting in the 49 relevant articles included in this review.
Results: This decision and the subsequent adjustment period is a difficult time for people with dementia and their family caregivers. Admission has been linked to increased behavioral symptoms and in particular depression and agitation, decreasing cognition, frailty, and falls in people with dementia. For caregivers, guilt, depression, feelings of failure, and continuing burden but also improvement in quality of life have been variously reported. Research to determine what influences the trajectory of these different outcomes and the prevalence of positive outcomes for people with dementia is lacking. Successful transitions may be assisted by ensuring that the person with dementia has input into decision making, orientation procedures for the person with dementia and family member prior to and on admission, a “buddy” system for new arrivals, and a person-centered approach.
Conclusions: Adjustment to admission to residential care can be difficult for people with dementia and their family caregivers. Longitudinal research examining factors influencing the adjustment can provide a basis for intervention trials to improve this transition.