Development and Preliminary Validation of the Adult Asthma Adherence Questionnaire™ - By Michael Schatz, MD, MS, Robert S. Zeiger, MD, PhD, Su-Jau Yang, PhD, Andrew G. Weinstein, MD, Wansu Chen, MS, Renee N. Saris-Baglama, PhD, and Diane M. Turner-Bowker
Description
Journal of Asthma and Clinical Immunology: In Practice, May 2013 - Asthma medication adherence is related to better asthma outcomes, but identification of suboptimal patient adherence behavior is not standardized in clinical settings. In this article, the authors present a study that identified five questions that can be used clinically to identify patients at risk of nonadherence and the specific adherence barriers involved to allow targeted intervention to improve adherence.
DownloadAssessing Suicide Risk
Description
European Pharmaceutical Contractor, December 2012 - The US FDA regulatory Guidance on Suicidal Ideation and Behaviour has been reviewed and re-released as study teams are concerned with patient safety, regulatory compliance and reducing site burden. This article provides an overview of the revised FDA draft guidance, the limitations of the C-SSRS and the benefits of the eC-SSRS in meeting this FDA requirement.
DownloadProspective Assessment Of Suicidal Ideation and Behavior (SIB) In Clinical Trials - By Michael Federico
Description
Life Science Leader, December 2012 - The U.S. FDA has revised its Guidance on Prospective Assessment of Suicidal Ideation and Behavior (SIB), suggesting that in addition to being required for psychiatric trials, it also applies to depression, smoking cessation, weight loss, and other studies of drugs that appear to have a CNS effect. This article reviews how researchers can meet the FDA's expectations in capturing this important assessment, regardless of the therapeutic area being studied.
DownloadSubject Experience Diaries in Clinical Research - By Saul Shiffman, Michael R. Hufford, and Jean Paty
Description
Applied Clinical Trials, March 2001 - Part I: The Patient Experience Movement & Part II: Ecological Momentary Assessment [formerly an invivodata resource]
DownloadPrediction of peak flow values followed by feedback improves perception of lung function and adherence to inhaled corticosteroids in children with asthma - By J. Feldman, H. Kutner, L. Matte, M. Lupkin, D. Steinberg, K. Sidora-Arcoleo, D. Serebrisky, K.
Description
Thorax, November 2012 - This article shows that feedback on PEF predictions for ethnic minority, inner-city children may decrease underperception of respiratory compromise and increase adherence to controller medications. Children and their families may shift their attention to asthma perception and management as a result of this intervention. This study used ERT's AM2 electronic spirometer and eDiary for PEF data collection.
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