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Background: Clinical trial sponsors rely on research sites to identify and enroll appropriate study participants and to correctly and reliably assess symptom severity and function over the course of the trial. Low-recruiting sites represent a large financial and operational burden and may negatively impact trial success either by selecting inappropriate participants and/or high prevalence of data quality issues. We previously reported that >60% of sites in schizophrenia clinical trials recruited ≤5 participants.
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Alzheimers Dement
December 2024
Center for Health + Technology, University of Rochester Medical Center, Rochester, NY, USA.
Background: In preparation for therapeutic trails involving patients with Alzheimer's disease (AD) and mild cognitive impairment (MCI), there is a need for valid, disease-specific caregiver-reported outcome (CRO) measures capable of tracking symptomatic burden in response to therapy over time. CROs are useful tools in clinical trials for individuals with AD, MCI, and dementia who are unable to self-report. In addition, CROs are accepted by the United States Food and Drug Administration to support regulatory claims.
View Article and Find Full Text PDFDrug Development.
Alzheimers Dement
December 2024
Center for Health + Technology, University of Rochester Medical Center, Rochester, NY, USA.
Background: To bolster clinical trial infrastructure, there is a need to develop novel, valid, and reliable patient-reported outcome (PRO) measures capable of tracking clinically-relevant changes in Alzheimer's disease (AD), Mild Cognitive Impairment (MCI) and dementia over time. This research describes the development and validation of the Alzheimer's Disease-Health Index (AD-HI) as a tool to measure how patients feel and function in response to therapeutic intervention.
Method: We previously conducted semi-structured qualitative interviews and a national cross-sectional study with individuals with AD, MCI and dementia to ascertain the most prevalent and impactful symptoms identified by the participants.
Dementia Care Research and Psychosocial Factors.
Alzheimers Dement
December 2024
University College London, London, United Kingdom.
Background: The progressive nature of dementia and the complex needs means that people living with dementia require tailored approaches to address their changing care needs over time. These include physical multimorbidity, psychological, behavioural, and cognitive symptoms and possible risks arising from these and helping family caregivers. However, provision of these interventions is highly variable between and within countries, partly due to uncertainty about their efficacy and scarce resources.
View Article and Find Full Text PDFDementia Care Research and Psychosocial Factors.
Alzheimers Dement
December 2024
7072 mulago hill, Kampala, Uganda.
Background: In Uganda, caregivers of Alzheimer's disease and related dementias (ADRD) face complex challenges, often lacking specialized skills for effective caregiving. Despite the growing prevalence of ADRD in the country, there's a significant literature gap on caregiver selection and obstacles faced in urban and rural areas. This study aims to provide insights into the experiences of Ugandan caregivers, enhancing understanding of ADRD caregiving.
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