arXiv subjects

Dalia Dawoud

Publications and source records attributed to Dalia Dawoud.

4 recordsLinked to original sources

arXiv2025

ELEVATE-GenAI: Reporting Guidelines for the Use of Large Language Models in Health Economics and Outcomes Research: an ISPOR Working Group on Generative AI Report

Introduction: Generative artificial intelligence (AI), particularly large language models (LLMs), holds significant promise for Health Economics and Outcomes Research (HEOR). However, standardized reporting guidance for LLM-assisted research is lacking. This article introduces the ELEVATE GenAI framework and checklist - reporting guidelines specifically designed for HEOR studies involving LLMs. Methods: The framework was developed through a targeted literature review of existing reporting guidelines, AI evaluation frameworks, and expert input from the ISPOR Working Group on Generative AI. It comprises ten domains, including model characteristics, accuracy, reproducibility, and fairness and bias. The accompanying checklist translates the framework into actionable reporting items. To illustrate its use, the framework was applied to two published HEOR studies: one focused on systematic literature review tasks and the other on economic modeling. Results: The ELEVATE GenAI framework offers a comprehensive structure for reporting LLM-assisted HEOR research, while the checklist facilitates practical implementation. Its application to the two case studies demonstrates its relevance and usability across different HEOR contexts. Limitations: Although the framework provides robust reporting guidance, further empirical testing is needed to assess its validity, completeness, usability, as well as its generalizability across diverse HEOR use cases. Conclusion: The ELEVATE GenAI framework and checklist address a critical gap by offering structured guidance for transparent, accurate, and reproducible reporting of LLM-assisted HEOR research. Future work will focus on extensive testing and validation to support broader adoption and refinement.

cs.CY↗

arXiv2025

Evaluating amyloid-beta as a surrogate endpoint in trials of anti-amyloid drugs in Alzheimer's disease: a Bayesian meta-analysis

The use of amyloid-beta (A$β$) clearance to support regulatory approvals of drugs in Alzheimer's disease (AD) remains controversial. We evaluate A$β$ as a potential trial-level surrogate endpoint for clinical function in AD using a meta-analysis. Randomised controlled trials (RCTs) reporting data on the effectiveness of anti- A$β$ monoclonal antibodies (MABs) on A$β$ and clinical outcomes were identified through a literature review. A Bayesian bivariate meta-analysis was used to evaluate surrogate relationships between the treatment effects on A$β$ and clinical function, with the intercept, slope and variance quantifying the trial level association. The analysis was performed using RCT data both collectively across all MABs and separately for each MAB through subgroup analysis. The latter analysis was extended by applying Bayesian hierarchical models to borrow information across treatments. We identified 23 RCTs with 39 treatment contrasts for seven MABs. The association between treatment effects on A$β$ and Clinical Dementia Rating - Sum of Boxes (CDR-SOB) across all MABs was strong: with intercept of -0.03 (95% credible intervals: -0.16, 0.11), slope of 1.41 (0.60, 2.21) and variance of 0.02 (0.00, 0.05). For individual treatments, the surrogate relationships were suboptimal, displaying large uncertainty. The use of hierarchical models considerably reduced the uncertainty around key parameters, narrowing the intervals for the slopes by an average of 71% (range: 51%-95%) and for the variances by 28% (7%-65%). Our results suggest that A$β$ is a potential surrogate endpoint for CDR-SOB when assuming a common surrogate relationship across all MABs. When allowing for information-sharing, the surrogate relationships improved, but only for lecanemab and aducanumab was the improvement sufficient to support a surrogate relationship.

stat.AP↗

arXiv2025

Generative AI in Health Economics and Outcomes Research: A Taxonomy of Key Definitions and Emerging Applications, an ISPOR Working Group Report

Objective: This article offers a taxonomy of generative artificial intelligence (AI) for health economics and outcomes research (HEOR), explores its emerging applications, and outlines methods to enhance the accuracy and reliability of AI-generated outputs. Methods: The review defines foundational generative AI concepts and highlights current HEOR applications, including systematic literature reviews, health economic modeling, real-world evidence generation, and dossier development. Approaches such as prompt engineering (zero-shot, few-shot, chain-of-thought, persona pattern prompting), retrieval-augmented generation, model fine-tuning, and the use of domain-specific models are introduced to improve AI accuracy and reliability. Results: Generative AI shows significant potential in HEOR, enhancing efficiency, productivity, and offering novel solutions to complex challenges. Foundation models are promising in automating complex tasks, though challenges remain in scientific reliability, bias, interpretability, and workflow integration. The article discusses strategies to improve the accuracy of these AI tools. Conclusion: Generative AI could transform HEOR by increasing efficiency and accuracy across various applications. However, its full potential can only be realized by building HEOR expertise and addressing the limitations of current AI technologies. As AI evolves, ongoing research and innovation will shape its future role in the field.

cs.LG↗

arXiv2024

Generative AI for Health Technology Assessment: Opportunities, Challenges, and Policy Considerations

This review introduces the transformative potential of generative Artificial Intelligence (AI) and foundation models, including large language models (LLMs), for health technology assessment (HTA). We explore their applications in four critical areas, evidence synthesis, evidence generation, clinical trials and economic modeling: (1) Evidence synthesis: Generative AI has the potential to assist in automating literature reviews and meta-analyses by proposing search terms, screening abstracts, and extracting data with notable accuracy; (2) Evidence generation: These models can potentially facilitate automating the process and analyze the increasingly available large collections of real-world data (RWD), including unstructured clinical notes and imaging, enhancing the speed and quality of real-world evidence (RWE) generation; (3) Clinical trials: Generative AI can be used to optimize trial design, improve patient matching, and manage trial data more efficiently; and (4) Economic modeling: Generative AI can also aid in the development of health economic models, from conceptualization to validation, thus streamlining the overall HTA process. Despite their promise, these technologies, while rapidly improving, are still nascent and continued careful evaluation in their applications to HTA is required. To ensure their responsible use and implementation, both developers and users of research incorporating these tools, should familiarize themselves with their current limitations, including the issues related to scientific validity, risk of bias, and consider equity and ethical implications. We also surveyed the current policy landscape and provide suggestions for HTA agencies on responsibly integrating generative AI into their workflows, emphasizing the importance of human oversight and the fast-evolving nature of these tools.

cs.LG↗