To send content items to your account,
please confirm that you agree to abide by our usage policies.
If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account.
Find out more about sending content to .
To send content items to your Kindle, first ensure firstname.lastname@example.org
is added to your Approved Personal Document E-mail List under your Personal Document Settings
on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part
of your Kindle email address below.
Find out more about sending to your Kindle.
Note you can select to send to either the @free.kindle.com or @kindle.com variations.
‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi.
‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.
OBJECTIVES/GOALS: Innovations with positive health impact are a high priority for NCATS and CTSAs. Program design that uses the Causal Pathway approach incorporates performance indicators that assess impact. We applied Causal Pathway thinking to an ongoing national program to enhance the evaluation of program impact. We report Lessons Learned. METHODS/STUDY POPULATION: We conducted a day-long onsite workshop to introduce the model to the project team, build capacity, and map the existing program elements to Logic Models representing program Specific Aims. A local Causal Pathway (CP) champion was identified. Alignment of the Logic Models with the CP approach (input→activities→ outputs→effects/impact) developed iteratively through biweekly, then monthly conferral among stakeholders. Key tasks included distinguishing among activities, outputs, and effects (impacts), and identification of performance indicators for each stage of the Causal Pathway. Visualization tools and an additional late stage half-day workshop were used to foster consensus. Implementation of the CP model tested the feasibility of collecting specific indicators and prompted model revisions. RESULTS/ANTICIPATED RESULTS: Program leadership and team members (n = 30) participated in the kick-off workshop. Four Specific Aims were mapped to Logic Models. Multiple Causal Pathway (CP) diagrams, one for each project in the program, were developed and mapped to Aims. Alignment of CP threads to Aims and identification of performance indicators required iteration. CP threads converged onto common final Impacts, sometimes crossing to another Aim. Performance indicators for operations were readily accessible to team members, and less so for impacts. Assumptions about program effects were subjected to specific indicators. Over time, Leadership noticed more expression of CP thinking in daily activities. New projects developed during this period incorporated the CP approach. Teams were able to streamline and simplify Logic/CP models. DISCUSSION/SIGNIFICANCE OF IMPACT: Through capacity-building and mentored exercises, an innovation team was able to infuse CP thinking into the evaluation of their ongoing program. The CP approach to design and evaluation maps progress and indicators across the life of a program from initial activities to its ultimate impact.
The updated common rule, for human subjects research, requires that consents “begin with a ‘concise and focused’ presentation of the key information that will most likely help someone make a decision about whether to participate in a study” (Menikoff, Kaneshiro, Pritchard. The New England Journal of Medicine. 2017; 376(7): 613–615.). We utilized a community-engaged technology development approach to inform feature options within the REDCap software platform centered around collection and storage of electronic consent (eConsent) to address issues of transparency, clinical trial efficiency, and regulatory compliance for informed consent (Harris, et al. Journal of Biomedical Informatics 2009; 42(2): 377–381.). eConsent may also improve recruitment and retention in clinical research studies by addressing: (1) barriers for accessing rural populations by facilitating remote consent and (2) cultural and literacy barriers by including optional explanatory material (e.g., defining terms by hovering over them with the cursor) or the choice of displaying different videos/images based on participant’s race, ethnicity, or educational level (Phillippi, et al. Journal of Obstetric, Gynecologic, & Neonatal Nursing. 2018; 47(4): 529–534.).
We developed and pilot tested our eConsent framework to provide a personalized consent experience whereby users are guided through a consent document that utilizes avatars, contextual glossary information supplements, and videos, to facilitate communication of information.
The eConsent framework includes a portfolio of eight features, reviewed by community stakeholders, and tested at two academic medical centers.
Early adoption and utilization of this eConsent framework have demonstrated acceptability. Next steps will emphasize testing efficacy of features to improve participant engagement with the consent process.
Early studies of children’s questions focused primarily on the epistemic motive that prompted them. Increasingly, however, investigators have recognized that questions are situated within a dialogue in which the child’s interlocutor and the answers that the interlocutor supplies are likely to determine what children learn from their questions and the broader stance that children take to curiosity–driven conversations. Moreover, children do not ask questions with one single motive. Many of their questions are aimed at gathering information about the world but some are aimed at securing help, or permission or clarification of what has just been said. Even in the second year of life toddlers use nonverbal gestures such as pointing to seek input from a partner. Such gestures appear to be interrogative in the sense that information provided in their wake is especially well remembered. Toddlers also signal their ignorance again nonverbally via shrug gestures but increasingly via explicit admissions of ignorance: “I don’t know.” Finally, despite the alleged lack of metacognitive awareness among young children, they are prompt in seeking to resolve comprehension glitches by asking clarification questions.
Research opportunities associated with the proliferation of the electronic health record (EHR), big data initiatives, and innovative approaches to trial design can present challenges for obtaining and documenting informed consent. Broad-scale informed consent (a term used herein to describe institutional models, rather than the Common Rule’s strict regulatory definition for “broad consent”) may facilitate the use of existing data and samples and speed the pace of research by minimizing barriers to consent. We explored the use of broad-scale informed consent within the Clinical Translational Science Award (CTSA) Program Network.
We surveyed CTSA Hubs concerning policies, practices, experiences, and needs within three domains of broad-scale informed consent: (1) participant recontact; (2) biospecimens; and (3) clinical data sharing.
Of 61 CTSA Hubs surveyed, 37 (61%) indicated ongoing work related to at least 1 domain of broad-scale informed consent; 18 Hubs (30%) reported work in all 3 domains. The EHR predominated as the implementation system across all three domains. Research and IT leadership and the Institutional Review Board were most commonly endorsed as institutional drivers, while systems/technical issues and impact on clinical workflow were the most commonly reported barriers.
While survey results indicate considerable variability in the implementation of broad-scale informed consent across the CTSA consortium, it is clear that all CTSA Hubs are actively considering policy and process related to these concepts. Next steps cluster within three areas: training and workforce development, streamlined policies and templates, and implementation strategies that facilitate integration into clinical workflow.
How, in the 1970s, did a generation whose motto was “never trust anyone over thirty” come to grips with an iconic 1960s rock band whose members were entering their mid-thirties? On the whole, not very well. Mick Jagger, in an unguarded moment, wistfully observed: “I’m afraid rock and roll has no future … It’s only recycled past.”1 The mid-1970s was a time of considerable turmoil and transition for the Stones, and for rock music in general.2 The music industry was still sorting itself out after the breakup of the Beatles at the very beginning of the 1970s. Historically, the spread of the bucolic culture envisioned by Woodstock already seemed in rot. The 1970s were riven with crises – Vietnam, Watergate, labor strife in Britain, the Troubles in Northern Ireland, global concerns about pollution and overpopulation, the energy crisis, planned obsolescence, the Munich Olympic massacre, the Biafran War, the India-Pakistan War, and the Yom Kippur War, are only a few of the most important calamities that mark the decade. Amidst this turbulence – often simplistically chronicled in rock history by contrasting the Stones’ dystopian concert at Altamont with the utopian ideals of Woodstock – the Rolling Stones faced a novel predicament: how to remain at the forefront of rock while entering a stage of life more traditionally associated with conventional adulthood.
Recent research has shown that children often learn what to believe by attending to the claims of other people. Similarly, they often learn how to act by attending to the actions of other people. Moreover, in each of these two domains, children are selective in their learning – they prefer to endorse and to emulate individuals who, as representatives of the surrounding culture, can serve as good models. I argue that this type of selective social learning also plays a major role in children’s emotional development. Although young children may encounter some situations that have a universal biological significance – for example a steep cliff or a sudden loud noise – the emotional implications of many encounters, especially with artefacts, people and foods, are likely to vary from one culture to another. Children can learn to perceive these encounters through the distinctive emotional lens of their own culture if they attend to and adopt the expressive appraisals of individuals who are representative of their culture. Such appraisals may be conveyed non-verbally, as in the classic social-referencing paradigm, but they can also be conveyed verbally.
Individuals experiencing different medical conditions, as well as healthy volunteers, may often be interested in trial participation, and researchers similarly need to find participants to advance medical knowledge. The ResearchMatch (RM) Trials Today clinical trial searching tool leverages clinicaltrials.gov data to enable potential participants to look for trial opportunities relevant to their situation. To facilitate expanded use of this tool, we undertook a national digital public awareness campaign to increase awareness of Trials Today among members of the general public.
The awareness campaign promoted Trials Today using Facebook and digital banner messages in 2017, encompassing nine cities across the USA. The digital strategy was complemented by print media in several outlets. We employed descriptive statistics to summarize campaign metrics and site usage data during the campaign.
The campaign was successful in increasing visits to Trials Today, with 142,303 sessions logged during its run, as compared to pre-campaign data indicating 104,688 total sessions during the entire 2-year period since the site’s inception. The city-specific click-through rate for all digital impressions, combining Facebook and banner messaging, ranged from 0.50% to 1.09%, resulting in a cost-per-click range of $0.69–$1.15. In addition, visitors conducted 29,697 searches and viewed individual trial records 173,512 times.
The public awareness campaign was successful in increasing use of the RM Trials Today clinical trial searching tool. Our findings support the value of digital media messaging as a cost-effective vehicle for promoting clinical trial awareness, especially for chronic ailments.
An increase in “unusual” news with negative sentiment predicts an increase in stock market volatility. Unusual positive news forecasts lower volatility. Our analysis is based on over 360,000 articles on 50 large financial companies, published during the period of 1996–2014. Unusualness interacted with sentiment forecasts company-specific and aggregate volatility several months ahead. Furthermore, unusual news is reflected more slowly in aggregate volatility than company-specific volatility. News measures from articles explicitly about the “market,” which are more easily accessible to investors, do not forecast volatility. The observed responses of volatility to news may be explained by attention constraints on investors.
After the Civil War, northern Methodists undertook a successful mission to recruit a biracial membership in the South. Their Freedmen's Aid Society played a key role in outreach to African Americans, but when the denomination decided to use Society funds in aid of schools for Southern whites, a national controversy erupted over the refusal of Chattanooga University to admit African Americans. Caught between a principled commitment to racial brotherhood and the pressures of expediency to accommodate a growing white supremacist commitment to segregation, Methodists engaged in an agonized and heated debate over whether schools intended for whites should be allowed to exclude blacks. Divisions within the leadership of the Methodist Episcopal Church caught the attention of the national press and revealed the limits of even the most well-intentioned efforts to advance racial equality in the years after Reconstruction.