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Conducting patient interviews within a clinical trial setting
Qualitative data centered on patients’ experiences and perspectives typically go uncollected in clinical trial settings. Yet patients’ treatment experiences offer complementary insights and context on topics such as disease management, treatment gaps, and previous treatments outside of those gathered in traditional patient-reported outcome questionnaires. Qualitative interviews can capture patients’ perceptions of treatment needs, more fully explore meaningful changes experienced as a result of treatment, and reveal outcomes that are most important to patients. Asking patients detailed questions can provide insight into the “why” of a patient’s expressed thought or feeling. The inclusion of patient interviews within clinical trials is a relatively new and evolving field of research. This article delineates the types of data that may be collected during interviews with clinical trial participants and outlines two approaches to conducting qualitative research in the clinical trial setting, with a focus on maximizing the value of the resulting data.
Risk evaluation and mitigation strategy assessments
On May 3, 2012, the US Food and Drug Administration announced a public workshop to receive input on “survey methodologies and instruments that can be used to evaluate patients’ and health care providers’ knowledge about the risks of drugs marketed with an approved REMS [risk evaluation and mitigation strategy].” The FDA intended to use this input to help develop guidance to industry regarding best practices for such research. In the announcement to the meeting, entitled “Risk Evaluation and Mitigation Strategy (REMS) Assessments: Social Science Methodologies to Assess Goals Related to Knowledge: Public Workshop,” the FDA provided an issue paper summarizing experience with prior R...
The Marriage License Bonds of Westmoreland County, Virginia, from 1786-1850
Abstracted from the records in the Clerk's Office of Westmoreland County, this work contains a list of about 2,500 marriage bonds showing the names of approximately 6,000 brides, grooms, parents and sureties, the exact date of each bond, and, in some instances, the contracting parties' dates of birth and the place of marriage. With a brides' index.
True Heroines
Describes the circumstances and events which led to the 138 women law enforcement officers who died in the line of duty, the identity of their perpetrator(s), and the deposition of the case, with a biography and photo of each officer and their descendants. Author Dr. William Wilbanks carefully researched each case and unveiled the mystery of unsolved deaths.
A Little Something Different
The distinctive new crowdsourced publishing imprint Swoon Reads proudly presents its first published novel—an irresistibly sweet romance between two college students told from 14 different viewpoints. The creative writing teacher, the delivery guy, the local Starbucks baristas, his best friend, her roommate, and the squirrel in the park all have one thing in common—they believe that Gabe and Lea should get together. Lea and Gabe are in the same creative writing class. They get the same pop culture references, order the same Chinese food, and hang out in the same places. Unfortunately, Lea is reserved, Gabe has issues, and despite their initial mutual crush, it looks like they are never going to work things out. But somehow even when nothing is going on, something is happening between them, and everyone can see it. You'll be rooting for Gabe and Lea too, in Sandy Hall's quirky, completely original novel A Little Something Different, chosen by readers, writes, and publishers, to be the debut titles for the new Swoon Reads imprint!
Children's Understanding of Disability
Children's Understanding of Disability is a valuable addition to the debate surrounding the integration of children with special needs into ordinary schools. Taking the viewpoint of the children themselves, it explores how pupils with severe learning difficulties and their non-disabled classmates interact. Ann Lewis examines what happens when non-disabled children and pupils with severe learning difficulties work together regularly over the course of a year. She also includes the views of children working in segregated special education. From her findings, she draws implications for developing an inclusive ethos in schools and other communities.
My Neck of the Woods
Trans-Allegheny Pioneers is, without a doubt, one of the most celebrated accounts of life on the Virginia frontier ever written. The author's focal point is the region of the New River-Kanawha in present-day Montgomery and Pulaski counties, Virginia. This is essential reading for anyone interested in frontier history or the genealogies of mid-18th century families who resided in the Valley of Virginia.
