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12. Do beta-amyloid-targeted interventions improve cognition, physical functioning, and overt behaviour of Alzheimer's Disease (AD) patients: Protocol for meta-analysis of Phase 3 clinical trials both completed and terminated.

Author

Stellick, Chelsea Ann, Greenshaw, Andrew, Paulden, Mike, Yap, Sidney, Marshall, R. Tyler, Kung, Janice Y., and Spackman, Eldon

Subjects
CLINICAL trials, ALZHEIMER'S disease, MILD cognitive impairment, PHYSICAL mobility, AMYLOID
Abstract

Accumulation of amyloid-beta (Aβ) in the brain has been explored as a primary cause of Alzheimer's Disease (AD). Better known as the amyloid hypothesis, it has been the main target of researchers vying to bring their therapeutic interventions to market despite several failed attempts by predecessors. In June 2021, Aduhelm (Aducanumab) became the first U.S. Food and Drug Administration (FDA) approved treatment for AD based on the amyloid hypothesis in which sparked controversy. This meta-analysis aims to investigate the efficacy of amyloid-beta targeting interventions at all stages of the disease including the prodromal or mild cognitive impairment (MCI) stage compared to placebo. All completed and terminated Phase III trials are assessed to provide a comprehensive overview of interventions targeting amyloid-beta to inform the legitimacy of the amyloid hypothesis. [ABSTRACT FROM AUTHOR]

Published
2024
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22. We need to talk about values: a proposed framework for the articulation of normative reasoning in health technology assessment.

Author

Charlton, Victoria, DiStefano, Michael, Mitchell, Polly, Morrell, Liz, Rand, Leah, Badano, Gabriele, Baker, Rachel, Calnan, Michael, Chalkidou, Kalipso, Culyer, Anthony, Howdon, Daniel, Hughes, Dyfrig, Lomas, James, Max, Catherine, McCabe, Christopher, O'Mahony, James F., Paulden, Mike, Pemberton-Whiteley, Zack, Rid, Annette, and Scuffham, Paul

Subjects
TECHNOLOGY assessment, MEDICAL technology, VALUES (Ethics), PRACTICAL reason, RESEARCH personnel
Abstract

It is acknowledged that health technology assessment (HTA) is an inherently value-based activity that makes use of normative reasoning alongside empirical evidence. But the language used to conceptualise and articulate HTA's normative aspects is demonstrably unnuanced, imprecise, and inconsistently employed, undermining transparency and preventing proper scrutiny of the rationales on which decisions are based. This paper – developed through a cross-disciplinary collaboration of 24 researchers with expertise in healthcare priority-setting – seeks to address this problem by offering a clear definition of key terms and distinguishing between the types of normative commitment invoked during HTA, thus providing a novel conceptual framework for the articulation of reasoning. Through application to a hypothetical case, it is illustrated how this framework can operate as a practical tool through which HTA practitioners and policymakers can enhance the transparency and coherence of their decision-making, while enabling others to hold them more easily to account. The framework is offered as a starting point for further discussion amongst those with a desire to enhance the legitimacy and fairness of HTA by facilitating practical public reasoning, in which decisions are made on behalf of the public, in public view, through a chain of reasoning that withstands ethical scrutiny. [ABSTRACT FROM AUTHOR]

Published
2024
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26. Challenges of calculating cost-effectiveness thresholds

Author

Vallejo-Torres, Laura, primary, Claxton, Karl, additional, Edney, Laura C, additional, Karnon, Jonathan, additional, Lomas, James, additional, Ochalek, Jessica, additional, Paulden, Mike, additional, Stadhouders, Niek, additional, and Vanness, David J, additional

Published
2023
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29. Author Reply

Author

Paulden, Mike, Sampson, Chris, O’Mahony, James F., Spackman, Eldon, McCabe, Christopher, Round, Jeff, and Snowsill, Tristan

Published
2024
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30. We need to talk about values: a proposed framework for the articulation of normative reasoning in health technology assessment

Author

Charlton, Victoria, primary, DiStefano, Michael, additional, Mitchell, Polly, additional, Morrell, Liz, additional, Rand, Leah, additional, Badano, Gabriele, additional, Baker, Rachel, additional, Calnan, Michael, additional, Chalkidou, Kalipso, additional, Culyer, Anthony, additional, Howdon, Daniel, additional, Hughes, Dyfrig, additional, Lomas, James, additional, Max, Catherine, additional, McCabe, Christopher, additional, O'Mahony, James F., additional, Paulden, Mike, additional, Pemberton-Whiteley, Zack, additional, Rid, Annette, additional, Scuffham, Paul, additional, Sculpher, Mark, additional, Shah, Koonal, additional, Weale, Albert, additional, and Wester, Gry, additional

Published
2023
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34. Which interventions are cost-effective for the management of whiplash-associated and neck pain-associated disorders? A systematic review of the health economic literature by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration

Author

van der Velde, Gabrielle, Yu, Hainan, Paulden, Mike, Côté, Pierre, Varatharajan, Sharanya, Shearer, Heather M., Wong, Jessica J., Randhawa, Kristi, Southerst, Danielle, Mior, Silvano, Sutton, Deborah, Jacobs, Craig, and Taylor-Vaisey, Anne

Published
2016
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40. Management of neck pain and associated disorders: A clinical practice guideline from the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration

Author

Côté, Pierre, Wong, Jessica J., Sutton, Deborah, Shearer, Heather M., Mior, Silvano, Randhawa, Kristi, Ameis, Arthur, Carroll, Linda J., Nordin, Margareta, Yu, Hainan, Lindsay, Gail M., Southerst, Danielle, Varatharajan, Sharanya, Jacobs, Craig, Stupar, Maja, Taylor-Vaisey, Anne, van der Velde, Gabrielle, Gross, Douglas P., Brison, Robert J., Paulden, Mike, Ammendolia, Carlo, David Cassidy, J., Loisel, Patrick, Marshall, Shawn, Bohay, Richard N., Stapleton, John, Lacerte, Michel, Krahn, Murray, and Salhany, Roger

Published
2016
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43. Housing for vulnerable populations—identifying system cost implications: an analytic literature review.

Author

Kongats, Krystyna, Paulden, Mike, Pabayo, Roman, Campbell, Sandra, and Nykiforuk, Candace I J

Subjects
*INVESTMENTS, *COST control, *PUBLIC health, *SOCIAL justice, *MEDICAL care costs, *PUBLIC housing, *COST benefit analysis, *AT-risk people, *COST effectiveness, *SOCIAL services, *FOSTER home care
Abstract

We explored how investments in housing for vulnerable populations (including those experiencing homelessness) are described as leading to cost containment for the health, justice, and social service systems; the nature of any costs and benefits; and variations by housing type and over time. A structured search of peer-reviewed academic research focused on the core concepts of economic benefit, public housing programs, and vulnerable populations. Findings from 42 articles reporting on cost containment specific to health, justice, and social service systems at the municipal, regional, and/or state/provincial level were synthesized. Most of the studies focused on supportive housing interventions, targeted adults (mainly men) experiencing chronic homelessness in the USA, and reported results over 1–5 years. Approximately half of the articles reported on the costs required to house vulnerable populations. About half reported on funding sources, which is critical information for leadership decisions in cost containment for supportive housing. Most of the studies assessing program cost or cost-effectiveness reported a reduction in service costs and/or greater cost-effectiveness. Studies mostly reported impacts on health services, with hospital/inpatient care and emergency service use typically decreasing across the intervention types. All the studies that assessed cost impacts on the justice system reported a decrease in expenditures. Housing vulnerable populations was also found to decrease shelter service use and engagement with the foster care/welfare systems. Housing interventions may offer cost-savings in the short- and medium-term, with a limited evidence base also demonstrating long term benefit. [ABSTRACT FROM AUTHOR]

Published
2023
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46. sj-docx-1-mdm-10.1177_0272989X221097106 – Supplemental material for Trends in Author-Reported Cost-Effectiveness Thresholds in the United States from 1995 to 2018: Implications for Discount Rates

Author

Pandya, Ankur, Paulden, Mike, Zhu, Jinyi, Lavelle, Tara A., and Hammitt, James

Subjects
111708 Health and Community Services, 111799 Public Health and Health Services not elsewhere classified, 160807 Sociological Methodology and Research Methods, FOS: Health sciences, FOS: Sociology
Abstract

Supplemental material, sj-docx-1-mdm-10.1177_0272989X221097106 for Trends in Author-Reported Cost-Effectiveness Thresholds in the United States from 1995 to 2018: Implications for Discount Rates by Ankur Pandya, Mike Paulden, Jinyi Zhu, Tara A. Lavelle and James Hammitt in Medical Decision Making

Published
2022
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