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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.
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...
Cognitive Interviewing
"As both an academic instructor in questionnaire design and a research design methodologist for the federal government, I feel this book is very timely, useful for students and practitioners, and unique in its use of real world practical examples that most everyone can relate." —Terry Richardson, General Accounting Office "The combination of theory and practical application will make this a useful book for students as well as professionals who want to learn how to incorporate cognitive interviewing into the questionnaire design process." —Rachel Caspar, RTI International The design and evaluation of questionnaires—and of other written and oral materials—is a challenging endeavor, fra...
Haematology in Critical Care
Issues of thrombosis, bleeding, and transfusion are extremely common, and often complex, in critically ill patients. Haematology in Critical Care: A Practical Handbookprovidesa dependable source of expert guidance on how to handle common haematological problems seen in the critical care setting, as well as the acute care of patients with a primary haematological disorder. Full-time clinical haematologists, regularly attending on intensive care, the Editors begin with an approach to abnormal laboratory tests, following with a disease-orientated approach to topics such as coagulation and haematological malignancy. Other key topics include paediatric and neonatal care, transfusion, point of care testing and the emergency presentation of haematological disease. This title brings together two of the most highly scientific specialties in clinical practice, delivering a practical approach to these problems, and guiding the clinician through the diagnosis and management of common scenarios encountered in the ICU.
Peyronie's Disease
In this guidebook, international authorities review the current nonsurgical and surgical therapeutic options for dealing with Peyronie's disease. A variety of state-of-the-art research techniques is discussed. As the first medical text on the subject, this book provides an up-to-date summary of the etiology, natural history, and pathophysiology of this disease. Also discussed are the many misconceptions about Peyronie's disease.
Practice Guideline for the Treatment of Patients with Schizophrenia
The American Psychiatric Association (APA) is accredited by the Accreditation Council for Continuing Medical Education to sponsor continuing medical education for physicians.
Neurobiology of Psychiatric Disorders
This new volume in the Handbook of Clinical Neurology presents a comprehensive review of the fundamental science and clinical treatment of psychiatric disorders. Advances in neuroscience have allowed for dramatic advances in the understanding of psychiatric disorders and treatment. Brain disorders, such as depression and schizophrenia, are the leading cause of disability worldwide. It is estimated that over 25% of the adult population in North America are diagnosed yearly with at least one mental disorder and similar results hold for Europe. Now that neurology and psychiatry agree that all mental disorders are in fact, "brain diseases," this volume provides a foundational introduction to the...
Cosmetic Dermatology
"This title in the Requisites in Dermatology series is the perfect resource for quick reference and rapid review in cosmetic dermatology. It succinctly presents all of the most essential clinical and foundational knowledge you need for certification, recertification, or practice. An extremely user-friendly full-color format, replete with full-color clinical photographs and other pertinent illustrations, makes it easy to locate and read up on any topic. Plus, full-text online access lets you consult the book from any computer, download all of the images, watch online lectures, and more." --Book Jacket.
Schizophrenia Treatment Outcomes
This book analyzes schizophrenia management in the context of recent clinical therapeutic advances that have transformed the measurements and outcomes landscape. Unlike any other resource, this volume carefully develops the social and clinical guidelines that affect the life of the patient and defines its role in schizophrenia treatment outcomes. The text begins by determining the concepts, development, neuroscience, and guidelines for positive outcomes before analyzing the gaps in the literature. The text addresses medical concerns in relation to outcomes in schizophrenic patients, including substance use, impact from antipsychotic medications, and medical comorbidities. The text also cover...
