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Articles by Rachelle S. Doody
Total Records ( 4 ) for Rachelle S. Doody
  Peter J. Snyder , Kathryn V. Papp , Jennifer Bartkowiak , Colleen E. Jackson and Rachelle S. Doody
  A major barrier to progress in Alzheimer's disease treatment research is the increasingly difficult task of recruiting elderly participants into clinical trials. We conducted an anonymous online survey of 676 adults (average age, 50 years) to examine perceived trust in different components of our healthcare-delivery and clinical-research systems, as well as willingness to participate in clinical trials. Respondents indicated the greatest amount of trust in family members, followed by family physicians. Only 3% of respondents `completely` trusted clinical researchers, whereas 62% of respondents trusted them `somewhat` to care for them during the course of a clinical trial. Trust in clinical researchers was modestly negatively correlated with income (r = −0.165, P < .001), but was not significantly related to sex, race, or education. Respondents indicated the least amount of trust in industry sponsors, followed by regulatory authorities.
  Rachelle S. Doody
  Despite enormous worldwide public and private interest in improving the prevention and treatment of Alzheimer's disease (AD), we have not made as much of an impact as we would like, and the number of affected individuals continues to grow. Even more alarmingly, whereas global efforts to identify AD cases and to develop new treatments are increasing, patient-care options are disappearing, so that even if a highly efficacious therapy or prevention approach arose, it would not be used effectively. As a first step toward organizing a better way forward, we should establish AD centers of excellence that mandate both patient care and research in the same setting. These centers would benefit from changes in public health policies related to chronic-disease surveillance, Center for Medicare and Medicaid Services funding for the care of chronic diseases, institutional review boards, good clinical practice guidelines, National Institutes of Health regulations for the use of research funds, Food and Drug Administration guidelines for the approval of AD drugs, and Department of Commerce regulations related to patent protection of AD diagnostic aids and treatments. This new form of AD centers of excellence would also provide direct care to many patients and their families, model care for communities and medical trainees, enhance the voluntary recruitment of AD patients to clinical trials, and improve our understanding of AD and its management.
  Rachelle S. Doody , Patricia E. Cole , David S. Miller , Eric Siemers , Ronald Black , Howard Feldman , Rachel Schindler , Stephen Graham , Theresa Heath , Ara S. Khachaturian , Rebecca Evans and Maria C. Carrillo
  The number of clinical trials for Alzheimer‘s disease conducted outside the United States in a broad array of countries is increasing. As the number of compounds ready for clinical testing increases, and as trials become longer and more complex, this trend is expected to grow. The cultural and ethical context of global clinical trials, potential benefits for those involved, and practical approaches to obstacles generated by these global trials were discussed at a meeting of the Alzheimer‘s Association Research Roundtable. Regulatory issues, including regional differences in study registration procedures, rules for collecting and reporting serious adverse events, requirements for national identity of study populations, and regulatory audits were also discussed by individuals who are knowledgeable about global clinical trials for Alzheimer‘s disease.
  Steve Balsis , Alexis A. Unger , Jared F. Benge , Lisa Geraci and Rachelle S. Doody
  Background The Alzheimer‘s Disease Assessment Scale-cognitive (ADAS-cog) is a commonly used measure for assessing cognitive dysfunction in patients with Alzheimer‘s disease (AD). The measure has 11 subscales, each of which captures an important aspect of cognitive dysfunction in AD. Traditional scoring of the ADAS-cog involves adding up the scores from the subscales without regarding their varying difficulty or their strength of relationship to AD-associated cognitive dysfunction. The present article analyzes problems associated with this approach and offers solutions for gaining measurement precision by modeling how the subscales function. Methods We analyzed data collected at the Baylor College of Medicine Alzheimer‘s Disease and Memory Disorders Clinic from 1240 patients diagnosed with varying degrees of dementia. Item response theory was used to determine the relationship between total scores on the ADAS-cog and the underlying level of cognitive dysfunction reflected by the scores. Results Results revealed that each total score corresponded to a spectrum of cognitive dysfunction, indicating that total scores were relatively imprecise indicators of underlying cognitive dysfunction. Furthermore, it was common for two individuals with the same total score to have significantly different degrees of cognitive dysfunction. Conclusions These findings suggest that item response theory scoring of the ADAS-cog may measure cognitive dysfunction more precisely than a total score method.
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