Open peer commentary on "Prescribing anti-amyloid immunotherapies to treat Alzheimer's disease: Fully informing patient decisions".
Ontology highlight
ABSTRACT:
SUBMITTER: Gandy S
PROVIDER: S-EPMC10661216 | biostudies-literature | 2023 Oct-Dec
REPOSITORIES: biostudies-literature
Publications
Open peer commentary on "Prescribing anti-amyloid immunotherapies to treat Alzheimer's disease: Fully informing patient decisions".
Alzheimer's & dementia (New York, N. Y.) 20231001 4
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Project description: Not available
| S-EPMC10865484 | biostudies-literature
Project description:IntroductionApproval of the anti-amyloid monoclonal antibodies has stimulated an important discussion of the value to be placed on the magnitude of slowing achieved by treatment compared to placebo.MethodsThe minimal clinically important difference (MCID) was reviewed in the context of other measures and analyses that provide perspective on the meaningfulness of treatment responses.ResultsTheMCID is a clinician-anchored approach to making this determination. The MCID applies best to symptomatic therapies for which the drug-placebo difference remains constant. Disease-modifying therapies produce a progressive divergence of drug and placebo trajectories; early in the course the MCID would not be achieved, later the MCID will be achieved, and with continuing therapy the MCID will be exceeded. Clinicians are not the only stakeholders involved in determining the value proposition of slowing disease progression. Patient-reported outcomes and caregiver-related measures offer important complementary insights. Analytic approaches also widen the perspective on the observed drug-placebo differences. Risk ratios, numbers needed to treat versus number needed to harm, time-to-event analyses, and predictive benefits based on biomarkers all add depth to the discussion.DiscussionMultiple stakeholder perspectives are needed to determine the importance to be attributed to the therapeutic changes observed with monoclonal antibody therapies and other emerging treatments.
| S-EPMC10372384 | biostudies-literature
Project description:The central challenge of the 21st century is to develop economic, social, and governance systems capable of ending poverty and achieving sustainable levels of population and consumption while securing the life-support systems underpinning current and future human well-being. Essential to meeting this challenge is the incorporation of natural capital and the ecosystem services it provides into decision-making. We explore progress and crucial gaps at this frontier, reflecting upon the 10 y since the Millennium Ecosystem Assessment. We focus on three key dimensions of progress and ongoing challenges: raising awareness of the interdependence of ecosystems and human well-being, advancing the fundamental interdisciplinary science of ecosystem services, and implementing this science in decisions to restore natural capital and use it sustainably. Awareness of human dependence on nature is at an all-time high, the science of ecosystem services is rapidly advancing, and talk of natural capital is now common from governments to corporate boardrooms. However, successful implementation is still in early stages. We explore why ecosystem service information has yet to fundamentally change decision-making and suggest a path forward that emphasizes: (i) developing solid evidence linking decisions to impacts on natural capital and ecosystem services, and then to human well-being; (ii) working closely with leaders in government, business, and civil society to develop the knowledge, tools, and practices necessary to integrate natural capital and ecosystem services into everyday decision-making; and (iii) reforming institutions to change policy and practices to better align private short-term goals with societal long-term goals.
| S-EPMC4475956 | biostudies-other
Project description:Open peer review (OPR), as with other elements of open science and open research, is on the rise. It aims to bring greater transparency and participation to formal and informal peer review processes. But what is meant by `open peer review', and what advantages and disadvantages does it have over standard forms of review? How do authors or reviewers approach OPR? And what pitfalls and opportunities should you look out for? Here, we propose ten considerations for OPR, drawing on discussions with authors, reviewers, editors, publishers and librarians, and provide a pragmatic, hands-on introduction to these issues. We cover basic principles and summarise best practices, indicating how to use OPR to achieve best value and mutual benefits for all stakeholders and the wider research community.
| S-EPMC6073088 | biostudies-other
Project description:BackgroundFor older adults with relapsing-onset multiple sclerosis (MS), limited information is available to inform if, or when, disease-modifying drugs (DMDs) may be safely discontinued.ObjectiveThe aim of this study was to project the outcomes of DMD discontinuation among older adults with relapsing-onset MS.MethodsWe projected the 10-year outcomes of discontinuation of a DMD (interferon-β, fingolimod, or natalizumab) among older adults (aged 55 or 70 years) who were relapse-free for 5 or more years and had not reached an Expanded Disability Status Scale (EDSS) score of 6. Outcomes included the percentage of people who had at least one relapse or reached EDSS 6, and quality-adjusted life-years (QALYs), which incorporated both relapses and disability. We used a simulation modeling approach. With increased age, relapses decreased and the effectiveness of DMDs for disability outcomes also decreased.ResultsWe found lower projected benefits for DMD continuation at 70 years of age than at 55 years of age. Compared with discontinuation, the projected benefit of DMD continuation ranged from 0.007 to 0.017 QALYs at 55 years of age and dropped to 0.002-0.006 at 70 years of age. The annual projected benefits of DMD continuation (0.1-3.0 quality-adjusted life-days) were very low compared with typical patient preferences regarding treatment burden.ConclusionThe benefits of DMDs may not be substantial among older adults with relapsing-onset MS. Direct clinical evidence remains limited and the decision of whether to discontinue a DMD should also take into account patient preferences. It is important to gain a better understanding of how age-related changes in the trajectory of relapsing-onset MS affect treatment effectiveness among older adults.
| S-EPMC7047543 | biostudies-literature
Project description: Not available
| S-EPMC555888 | biostudies-literature
Project description:Inter-ethnic differences in drug response are all too well known. These are underpinned by a number of factors, including pharmacogenetic differences across various ethnic populations. Precision medicine relies on genotype-based prescribing decisions with the aim of maximizing efficacy and mitigating the risks. When there is no access to genotyping tests, ethnicity is frequently regarded as a proxy of the patient's probable genotype on the basis of overall population-based frequency of genetic variations in the ethnic group the patient belongs to, with some variations being ethnicity-specific. However, ever-increasing transcontinental migration of populations and the resulting admixing of populations have undermined the utility of self-identified ethnicity in predicting the genetic ancestry, and therefore the genotype, of the patient. An example of the relevance of genetic ancestry of a patient is the inadequate performance of European-derived pharmacogenetic dosing algorithms of warfarin in African Americans, Brazilians and Caribbean Hispanics. Consequently, genotyping a patient potentially requires testing for all known clinically actionable variants that the patient may harbour, and new variants that are likely to be identified using state-of the art next-generation sequencing-based methods. Furthermore, self-identified ethnicity is associated with a number of ethnicity-related attributes and non-genetic factors that potentially influence the risk of phenoconversion (genotype-phenotype discordance), which may adversely impact the success of genotype-based prescribing decisions. Therefore, while genotype-based prescribing decisions are important in implementing precision medicine, ethnicity should not be disregarded.
| S-EPMC5753996 | biostudies-other
Project description:BackgroundWhole disease models (WDM) are large-scale, system-level models which can evaluate multiple decision questions across an entire care pathway. Whilst this type of model can offer several advantages as a platform for undertaking economic analyses, the availability and quality of existing WDMs is unknown.ObjectivesThis systematic review aimed to identify existing WDMs to explore which disease areas they cover, to critically assess the quality of these models and provide recommendations for future research.MethodsAn electronic search was performed on multiple databases (MEDLINE, EMBASE, the NHS Economic Evaluation Database and the Health Technology Assessment database) on 23rd July 2023. Two independent reviewers selected studies for inclusion. Study quality was assessed using the National Institute for Health and Care Excellence (NICE) appraisal checklist for economic evaluations. Model characteristics were descriptively summarised.ResultsForty-four WDMs were identified, of which thirty-two were developed after 2010. The main disease areas covered by existing WDMs are heart disease, cancer, acquired immune deficiency syndrome and metabolic disease. The quality of included WDMs is generally low. Common limitations included failure to consider the harms and costs of adverse events (AEs) of interventions, lack of probabilistic sensitivity analysis (PSA) and poor reporting.ConclusionsThere has been an increase in the number of WDMs since 2010. However, their quality is generally low which means they may require significant modification before they could be re-used, such as modelling AEs of interventions and incorporation of PSA. Sufficient details of the WDMs need to be reported to allow future reuse/adaptation.
| S-EPMC10501624 | biostudies-literature
Project description:There are numerous reasons to conduct scientific research within protected areas, but research activities may also negatively impact organisms and habitats, and thus conflict with a protected area's conservation goals. We developed a quantitative ecological decision-support framework that estimates these potential impacts so managers can weigh costs and benefits of proposed research projects and make informed permitting decisions. The framework generates quantitative estimates of the ecological impacts of the project and the cumulative impacts of the proposed project and all other projects in the protected area, and then compares the estimated cumulative impacts of all projects with policy-based acceptable impact thresholds. We use a series of simplified equations (models) to assess the impacts of proposed research to: a) the population of any targeted species, b) the major ecological assemblages that make up the community, and c) the physical habitat that supports protected area biota. These models consider both targeted and incidental impacts to the ecosystem and include consideration of the vulnerability of targeted species, assemblages, and habitats, based on their recovery time and ecological role. We parameterized the models for a wide variety of potential research activities that regularly occur in the study area using a combination of literature review and expert judgment with a precautionary approach to uncertainty. We also conducted sensitivity analyses to examine the relationships between model input parameters and estimated impacts to understand the dominant drivers of the ecological impact estimates. Although the decision-support framework was designed for and adopted by the California Department of Fish and Wildlife for permitting scientific studies in the state-wide network of marine protected areas (MPAs), the framework can readily be adapted for terrestrial and freshwater protected areas.
| S-EPMC6007909 | biostudies-literature
Project description:The Social Cash Transfer Programme (SCTP) in Malawi is a cross-sectoral policy with impacts on health, education, nutrition, agriculture and welfare. Implementation of the SCTP requires collaboration across sectors and across national and international stakeholders. Economic evaluation can inform investment by indicating whether benefits exceed costs, but economic evaluations that provide an overall benefit-cost ratio typically assume a common agreed objective and agreed set of value judgements. In reality, the various stakeholders involved in the delivery of the SCTP may have different remits and objectives and may differ in how they value the impacts of the programme. We use the SCTP as a case study to illustrate a cross-sectoral analytical framework that accounts for these differences. The stakeholders that contribute to the SCTP include the Ministry of Gender, Ministry of Finance, Ministry of Economic Planning and Development and Global Fund. We estimate how the SCTP changes outcomes in education, health, net production and poverty, and distinguish outcomes in three groups: SCTP recipients; population in Malawi not eligible for the SCTP and population in other countries. After estimating the direct effects and opportunity costs from investing in the SCTP, we summarize the results according to different perspectives. The SCTP is estimated to provide benefits in excess of costs from the perspective of national stakeholders. From the perspective of an international donor interested in health outcomes, its health benefits do not outweigh the opportunity costs unless health improvement in SCTP recipients is valued at 18 times that of other potential spending beneficiaries or the donor values broader outcomes than health alone. This work illustrates the potential of a cross-sectoral economic evaluation to guide debate about stakeholder contributions to the SCTP, and the value judgements required to favour the SCTP above other policy options.
| S-EPMC8757493 | biostudies-literature