Medical decision making often relies on accurately forecasting future patient trajectories. Conventional approaches for patient progression modeling often do not explicitly model treatments when predicting patient trajectories and outcomes. In this paper, we propose Alternating Transformer (AL-Transformer) to jointly model treatment and clinical outcomes over time as alternating sequential models. We leverage causal convolution in the self-attention mechanism of AL-Transformer to incorporate local spatial information in the sequence, thus enhancing the model's ability to capture local contextual information of the sequence. Additionally, to predict the sparse treatment, a constraint learned by a convolutional neural network (CNN) is used to constrain the sparse treatment output. Experimental results on two datasets from patients with sepsis and respiratory failure extracted from the Medical Information Mart for Intensive Care (MIMIC) database demonstrate the effectiveness of the proposed approach, outperforming existing state-of-the-art methods.
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http://dx.doi.org/10.1109/TBME.2023.3331298 | DOI Listing |
Background: Clinical outcome assessments (COAs) are an important part of clinical trials to measure what is meaningful to patients and caregivers. This study aimed to examine trends in Alzheimer's Disease (AD) COAs used in clinical trials, given the FDA's recent emphasis on patient-focused drug development and early AD.
Method: ClinicalTrials.
Alzheimers Dement
December 2024
Karolinska Institute, Stockholm, Södermanland and Uppland, Sweden.
Background: Novel anti-amyloid therapies (AAT) for Alzheimer's Disease (AD) have recently been approved in the United States, Japan and China, and are under regulatory review in Europe. Questions remain regarding the long-term effectiveness and value of these drugs when used in routine clinical practice. Data from follow-up studies will be important to inform their optimal use, including criteria for treatment initiation, monitoring strategies, stopping rules, pricing and reimbursement considerations.
View Article and Find Full Text PDFAlzheimers 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 PDFAlzheimers Dement
December 2024
University of California, Irvine, Irvine, CA, USA.
Background: Recruitment registries are tools to decrease the time and cost required to identify and enroll eligible participants into clinical research. Despite their potential to increase the efficiency of accrual, few analyses have assessed registry effectiveness. We investigated the outcomes of study referrals from the Consent-to-Contact (C2C) registry, a recruitment registry at the University of California, Irvine.
View Article and Find Full Text PDFBackground: Clinical outcome assessments (COAs) that measure functional capacities are key tools to evaluate efficacy in Alzheimer's disease (AD) clinical trials. The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale is frequently used to assess changes in both basic and instrumental activities of daily living, but there is no clear consensus on what magnitude of change on this scale may be considered clinically meaningful. To address this question, we conducted anchor-based analyses (as recommended by the FDA) to explore meaningful within-patient/participant change thresholds on the ADCS-ADL.
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