Clinical research in dementia: A perspective on implementing innovation.
Alzheimer's disease
clinical innovation
dementia
implementation
methodology
neurocognitive disorders
translational research
Journal
Alzheimer's & dementia : the journal of the Alzheimer's Association
ISSN: 1552-5279
Titre abrégé: Alzheimers Dement
Pays: United States
ID NLM: 101231978
Informations de publication
Date de publication:
11 2022
11 2022
Historique:
revised:
13
01
2022
received:
24
11
2021
accepted:
21
01
2022
pubmed:
25
3
2022
medline:
19
11
2022
entrez:
24
3
2022
Statut:
ppublish
Résumé
The increasing global prevalence of dementia demands concrete actions that are aimed strategically at optimizing processes that drive clinical innovation. The first step in this direction requires outlining hurdles in the transition from research to practice. The different parties needed to support translational processes have communication mismatches; methodological gaps hamper evidence-based decision-making; and data are insufficient to provide reliable estimates of long-term health benefits and costs in decisional models. Pilot projects are tackling some of these gaps, but appropriate methods often still need to be devised or adapted to the dementia field. A consistent implementation perspective along the whole translational continuum, explicitly defined and shared among the relevant stakeholders, should overcome the "research-versus-adoption" dichotomy, and tackle the implementation cliff early on. Concrete next steps may consist of providing tools that support the effective participation of heterogeneous stakeholders and agreeing on a definition of clinical significance that facilitates the selection of proper outcome measures.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2352-2367Informations de copyright
© 2022 The Authors. Alzheimer's & Dementia published by Wiley Periodicals LLC on behalf of Alzheimer's Association.
Références
Gauthier S, Rosa-Neto P, Morais JA & Webster C World Alzheimer Report 2021 World Alzheimer Report 2021 - Journey Through the Diagnosis of Dementia.
Estimation of the global prevalence of dementia in 2019 and forecasted prevalence in 2050: an analysis for the Global Burden of Disease Study 2019. Lancet Public Health. 2022. https://doi.org/10.1016/S2468-2667(21)00249-8
Europe Alzheimer. Comparing and Benchmarking European Dementia Monitor 2020: comparing and Benchmarking National Dementia Strategies and Policies. [European dementia monitor report 2020]. 2021. https://www.alzheimer-europe.org/sites/default/files/2021-11/European%20Dementia%20Monitor%202020%20%20Comparing%20and%20benchmarking%20national%20dementiastrategies%20and%20policies.pdf. Accessed Feb 7, 2022.
Lang L, Clifford A, Wei L, et al. Prevalence and determinants of undetected dementia in the community: a systematic literature review and a meta-analysis. BMJ Open. 2017;7(2):e011146. https://doi.org/10.1136/bmjopen-2016-011146.
Waldman SA, Terzic A. Clinical and translational science: from bench-bedside to global village. Clin Transl Sci. 2010;3(5):254-257. https://doi.org/10.1111/j.1752-8062.2010.00227.x.
Weisz JohnR, Ng MeiYi, Bearman SarahKate. Odd Couple? Reenvisioning the Relation Between Science and Practice in the Dissemination-Implementation Era. Clin Psychol Sci. 2014;2(1):58-74. https://doi.org/10.1177/2167702613501307.
WHO. Global action plan on the public health response to dementia 2017 - 2025. Accessed November 9, 2021. h ttps://www.who.int/publications/i/item/global-action-plan-on-the-public-health-response-to-dementia-2017-2025
Alzheimer's Disease International. Dementia Plans. Accessed January 5, 2022. https://www.alzint.org/what-we-do/policy/dementia-plans/
World Health Organization. The Global Dementia Observatory - Indicator Dictionary. [pdf]. Accessed April 1, 2021. https://extranet.who.int/dataform/upload/surveys/892154/images/gdo_data_dictionary.pdf
Grover SM. Shaping effective communication skills and therapeutic relationships at work: the foundation of collaboration. AAOHN J. 2005;53(4):177-182. quiz 186-7.
NIH. Programs for Physician-Scientists and Other Clinician-Scientists. https://www.nimh.nih.gov/funding/training/programs-for-physician-scientists-and-other-clinician-scientists
Cohrs RJ, Martin T, Ghahramani P, Bidaut L, Higgins PJ, Shahzad A (2014) Translational Medicine definition by the European Society for Translational Medicine. European Journal of Molecular & Clinical Medicine, 2(3), 86. https://doi.org/10.1016/j.nhtm.2014.12.002
Zimmern RL, Kroese M. The evaluation of genetic tests. J Public Health (Oxford, England). 2007;29(3):246-250. https://doi.org/10.1093/pubmed/fdm028.
Onken LS, Carroll KM, Shoham V, Cuthbert BN, Riddle M. Reenvisioning Clinical Science: unifying the Discipline to Improve the Public Health. Clin Psychol Sci. 2014;2(1):22-34. https://doi.org/10.1177/2167702613497932.
Manca A, Martinez G, Cugusi L, Dragone D, Dvir Z, Deriu F. The surge of predatory open-access in neurosciences and neurology. Neuroscience. 2017;353:166-173. https://doi.org/10.1016/j.neuroscience.2017.04.014.
Woods B, Aguirre E, Spector AE, Orrell M. Cognitive stimulation to improve cognitive functioning in people with dementia. Cochrane Database Syst Rev. 2012(2):CD005562. https://doi.org/10.1002/14651858.CD005562.pub2.
Bahar-Fuchs A, Martyr A, Goh AM, Sabates J, Clare L. Cognitive training for people with mild to moderate dementia. Cochrane Database Syst Rev. 2019;3(3):CD013069. https://doi.org/10.1002/14651858.CD013069.pub2.
Salzman C, Jeste DV, Meyer RE, et al. Elderly patients with dementia-related symptoms of severe agitation and aggression: consensus statement on treatment options, clinical trials methodology, and policy. J Clin Psychiatry. 2008;69(6):889-898. https://doi.org/10.4088/jcp.v69n0602.
Gove D, Diaz-Ponce A, Georges J, et al. Alzheimer Europe's position on involving people with dementia in research through PPI (patient and public involvement). Aging Mental Health. 2018;22(6):723-729. https://doi.org/10.1080/13607863.2017.1317334.
Rodríguez-Gómez O, Rodrigo A, Iradier F, et al. The MOPEAD project: advancing patient engagement for the detection of “hidden” undiagnosed cases of Alzheimer's disease in the community. Alzheimers Dement. 2019;15(6):828-839. https://doi.org/10.1016/j.jalz.2019.02.003.
Wolverson E, Dunn R, Moniz-Cook E, Gove D, Diaz-Ponce A. The language of behaviour changes in dementia: a mixed methods survey exploring the perspectives of people with dementia. J Adv Nurs. 2021;77(4):1992-2001. https://doi.org/10.1111/jan.14787.
Cotta Ramusino M, Perini G, Altomare D, et al. Outcomes of clinical utility in amyloid-PET studies: state of art and future perspectives. Eur J Nucl Med Mol Imaging. 2021;48(7):2157-2168. https://doi.org/10.1007/s00259-020-05187-x.
Frisoni GB, Boccardi M, Barkhof F, et al. Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers. Lancet Neurol. 2017;16(8):661-676. https://doi.org/10.1016/s1474-4422(17)30159-x.
EMA. Guideline on the Clinical Investigation of Medicines for the Treatment of Alzheimer's Disease; 2018. Accessed November 9, 2021. https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-investigation-medicines-treatment-alzheimers-disease-revision-2_en.pdf
Frisoni GB, Bocchetta M, Chetelat G, et al. Imaging markers for Alzheimer disease: which vs how. Neurology. 2013;81(5):487-500. https://doi.org/10.1212/WNL.0b013e31829d86e8.
Boccardi M, Gallo V, Yasui Y, et al. The biomarker-based diagnosis of Alzheimer's disease. 2-lessons from oncology. Neurobiol Aging. 2017;52:141-152. https://doi.org/10.1016/j.neurobiolaging.2017.01.021.
Isaacs J, Boenink M. Biomarkers for dementia: too soon for routine clinical use. Lancet Neurol. 2020;19:884-885. https://doi.org/10.1016/S1474-4422(20)30365-3.
Patnode CD, Perdue LA, Rossom RC, et al. Screening for Cognitive Impairment in Older Adults: updated Evidence Report and Systematic Review for the US Preventive Services Task Force. Jama. 2020;323(8):764-785. https://doi.org/10.1001/jama.2019.22258.
Whiting P, Rutjes AWS, Reitsma JB, Glas AS, Bossuyt PMM, Kleijnen J. Sources of variation and bias in studies of diagnostic accuracy: a systematic review. Ann Intern Med. 2004;140(3):189-202. https://doi.org/10.7326/0003-4819-140-3-200402030-00010.
Smailagic N, Vacante M, Hyde C, Martin S, Ukoumunne O, Sachpekidis C. (1)(8)F-FDG PET for the early diagnosis of Alzheimer's disease dementia and other dementias in people with mild cognitive impairment (MCI). Cochrane Database Syst Rev. 2015;1:Cd010632. https://doi.org/10.1002/14651858.CD010632.pub2.
Boccardi M, Festari C, Altomare D, et al. Assessing FDG-PET diagnostic accuracy studies to develop recommendations for clinical use in dementia. Eur J Nucl Med Mol Imaging. 2018;45(9):1470-1486. https://doi.org/10.1007/s00259-018-4024-1.
Boccardi M, Dodich A, Albanese E, et al. The strategic biomarker roadmap for the validation of Alzheimer's diagnostic biomarkers: methodological update. Eur J Nucl Med Mol Imaging. 2021;48(7):2070-2085. https://doi.org/10.1007/s00259-020-05120-2.
Goossens N, Nakagawa S, Sun X, Hoshida Y. Cancer biomarker discovery and validation. Transl Cancer Res. 2015;4(3):256-269. https://doi.org/10.3978/j.issn.2218-676X.2015.06.04.
Nelson M, Smith M & Ly A et al. ROADMAP D2.3 Stakeholder Generated Lists of Priority RWE Relevant Outcomes and D2.4 Disease Progression and Outcomes Classification Matrix. 2018. Published June 29, 2018. https://roadmap-alzheimer.org/wp-content/uploads/2018/07/ROADMAP_D2.3D2.4.pdf. Accessed Feb 7, 2022.
Oliver K, Innvar S, Lorenc T, Woodman J, Thomas J. A systematic review of barriers to and facilitators of the use of evidence by policymakers. BMC Health Serv Res. 2014;14:2. https://doi.org/10.1186/1472-6963-14-2.
Nguyen K-H, Comans TA, Green C. Where are we at with model-based economic evaluations of interventions for dementia? a systematic review and quality assessment. Int Psychogeriatr. 2018;30(11):1593-1605. https://doi.org/10.1017/S1041610218001291.
Sopina E, Sorensen J. Decision modelling of non-pharmacological interventions for individuals with dementia: a systematic review of methodologies. Health Econ Rev. 2018;8(1):8. https://doi.org/10.1186/s13561-018-0192-8.
Green C. Modelling disease progression in Alzheimer's disease: a review of modelling methods used for cost-effectiveness analysis. Pharmacoeconomics. 2007;25(9):735-750. https://doi.org/10.2165/00019053-200725090-00003.
Cohen JT, Neumann PJ. Decision analytic models for Alzheimer's disease: state of the art and future directions. Alzheimers Dement. 2008;4(3):212-222. https://doi.org/10.1016/j.jalz.2008.02.003.
Handels R, Wimo A. Challenges and recommendations for the health-economic evaluation of primary prevention programmes for dementia. Aging Mental Health. 2019;23(1):53-59. https://doi.org/10.1080/13607863.2017.1390730.
Gustavsson A, Green C, Jones RW, et al. Current issues and future research priorities for health economic modelling across the full continuum of Alzheimer's disease. Alzheimers Dement. 2017;13(3):312-321. https://doi.org/10.1016/j.jalz.2016.12.005.
de SilvaMJ, E Breuer, Lee L, et al. Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions. Trials. 2014;15:267. https://doi.org/10.1186/1745-6215-15-267.
Dementia Australia. Dementia language guidelines. Accessed December 30, 2020. https://www.dementia.org.au/sites/default/files/resources/dementia-language-guidelines.pdf
Gilmore-Bykovskyi A, Croff R, Glover CM, et al. Traversing the Aging Research and Health Equity Divide: toward Intersectional Frameworks of Research Justice and Participation. Gerontologist. 2021. https://doi.org/10.1093/geront/gnab107.
Hotopf M. The pragmatic randomised controlled trial. Advances in Psychiatric Treatment. 2002;8:326-333.
Equator Network. Enhancing the QUAlity and Transparency Of health Research. Accessed January 5, 2022. https://www.equator-network.org/
Jull J, Giles A, Graham ID. Community-based participatory research and integrated knowledge translation: advancing the co-creation of knowledge. Implement Sci. 2017;12(1):150. https://doi.org/10.1186/s13012-017-0696-3.
Israel BA, Schulz AJ, Parker EA, Becker AB. Review of community-based research: assessing partnership approaches to improve public health. Annu Rev Public Health. 1998;19:173-202. https://doi.org/10.1146/annurev.publhealth.19.1.173.
Carayannis E, Campbell D. ’Mode 3’ and ’Quadruple Helix’: toward a 21st century fractal innovation ecosystem. International Journal of Technology ‘Mode 3’ and ‘Quadruple Helix’: toward a 21st century fractal innovation ecosystem. Int J Technol. 2009;46(3-4):201-234.
Institutional Repository for Information Sharing. Community participation in local health and sustainable development: approaches and techniques. Accessed January 5, 2022. https://apps.who.int/iris/handle/10665/107341
Green C, Handels R, Gustavsson A, et al. Assessing cost-effectiveness of early intervention in Alzheimer's disease: an open-source modeling framework. Alzheimers Dement. 2019;15(10):1309-1321. https://doi.org/10.1016/j.jalz.2019.05.004.
Kansal AR, Tafazzoli A, Ishak KJ, Krotneva S. Alzheimer's disease Archimedes condition-event simulator: development and validation. Alzheimers Dement (New York, N Y). 2018;4:76-88. https://doi.org/10.1016/j.trci.2018.01.001.
Jutkowitz E, MacLehose RF, Gaugler JE, Dowd B, Kuntz KM, Kane RL. Risk Factors Associated With Cognitive, Functional, and Behavioral Trajectories of Newly Diagnosed Dementia Patients. J Gerontol A Biol Sci Med Sci. 2017;72(2):251-258. https://doi.org/10.1093/gerona/glw079.
Handels R, Jönsson L, Garcia-Ptacek S, Eriksdotter M, Wimo A. Controlling for selective dropout in longitudinal dementia data: application to the SveDem registry. Alzheimers Dement. 2020;16(5):789-796. https://doi.org/10.1002/alz.12050.
Mank A, Maurik IS, Bakker ED, et al. Identifying relevant outcomes in the progression of Alzheimer's disease; what do patients and care partners want to know about prognosis? Alzheimer's Dement.: Transl. Res. Clin. Interv. 2021;7(1). https://doi.org/10.1002/trc2.12189
Dunlop WCN, Mason N, Kenworthy J, Akehurst RL. Benefits, Challenges and Potential Strategies of Open Source Health Economic Models. Pharmacoeconomics. 2017;35(1):125-128. https://doi.org/10.1007/s40273-016-0479-8.
IPECAD. International Pharmaco-Economic Collaboration on Alzheimer's Disease. Accessed January 5, 2022. https://ipecadgroup.wordpress.com/
Wilde A de van Maurik IS, Kunneman M, et al. Alzheimer's biomarkers in daily practice (ABIDE) project: rationale and design. Alzheimers Dement (Amst). 2017;6:143-151.
Kunneman M, Pel-Littel R, Bouwman FH, et al. Patients' and caregivers' views on conversations and shared decision making in diagnostic testing for Alzheimer's disease: the ABIDE project. Alzheimers Dement (New York, N Y). 2017;3:314-322.
Poole M, Wilcock J, Rait G, Brodaty H, Robinson L. COGNISANCE Programme Team. Policy, practice, and public awareness: a review of national and international approaches to improve diagnosis and post-diagnostic support for people living with dementia: dementia care research: dementia care-models of care. Alzheimers Dement. 2020;16:e040918.
Caro JJ, Briggs AH, Siebert U, Kuntz KM. Modeling good research practices-overview. Med Decis Making. (2012);32(5):667-677. https://doi.org/10.1177/0272989x12454577
GRADE Handbook for Grading Quality of Evidence and Strength of Recommendations. 2013.
Higgins J, Thomas J, Chandler J, et al. Cochrane Handbook for Systematic Reviews of Interventions Version 6.2 (February 2021 update. Cochrane. 2021. https://training.cochrane.org/handbook/current
Ferguson JH. The NIH consensus development program. Joint Commission J Quality Improvement. 1995;21:332-336.
Herholz K, Westwood S, Haense C, Dunn G. Evaluation of a calibrated (18)F-FDG PET score as a biomarker for progression in Alzheimer disease and mild cognitive impairment. J Nucl Med. 2011;52:1218-1226.
Mitchell JD, Callagher P, Gardham J, et al. Timelines in the diagnostic evaluation of people with suspected amyotrophic lateral sclerosis (ALS)/motor neuron disease (MND)-a 20-year review: can we do better? Amyotroph Lateral Scler. 2010;11:537-541.
Mitchell SL, Mor V, Harrison J, McCarthy EP. Embedded Pragmatic Trials in Dementia Care: realizing the Vision of the NIA IMPACT Collaboratory. J Am Geriatr Soc. 2020;68(2):S1-S7.
Rodríguez-Gómez O, Rodrigo A, Iradier F, et al. The MOPEAD project: advancing patient engagement for the detection of “hidden” undiagnosed cases of Alzheimer's disease in the community. Alzheimers Dement. 2019;15:828-839.
Boccardi M, Gallo V, Yasui Y, et al. The biomarker-based diagnosis of Alzheimer's disease. 2-lessons from oncology. Neurobiol Aging. 2017;52:141-152.
Frisoni GB, Boccardi M, Barkhof F, et al. Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers. Lancet Neurol. 2017;16:661-676.
Pepe MS, Etzioni R, Feng Z, et al. Phases of biomarker development for early detection of cancer. J Natl Cancer Inst. 2001;93:1054-1061.
Zimmern RL, Kroese M. The evaluation of genetic tests. J Public Health (Oxford, England). 2007;29:246-250.
Woods B, Aguirre E, Spector AE, Orrell M. Cognitive stimulation to improve cognitive functioning in people with dementia. Cochrane Database Syst Rev. 2012(2):CD005562.
Bahar-Fuchs A, Martyr A, Goh AM, Sabates J, Clare L. Cognitive training for people with mild to moderate dementia. Cochrane Database Syst Rev. 2019;3:CD013069.
Bennett S, Laver K, Voigt-Radloff S, et al. Occupational therapy for people with dementia and their family carers provided at home: a systematic review and meta-analysis. BMJ Open. 2019;9(11):e026308.
Salzman C, Jeste DV, Meyer RE, et al. Elderly patients with dementia-related symptoms of severe agitation and aggression: consensus statement on treatment options, clinical trials methodology, and policy. J Clin Psychiatry. 2008;69:889-898.
Cohen-Mansfield J, Thein K, Marx MS. Dakheel-Ali M. What are the barriers to performing nonpharmacological interventions for behavioral symptoms in the nursing home? J Am Med Direct Assoc. 2012;13:400-405.
Liperoti R, Landi F. The management of behavioral and psychological symptoms of dementia: the need for tailored interventions. J Am Med Direct Assoc. 2013;14:306-307.
Na R, Yang J-H, Yeom Y, et al. A Systematic Review and Meta-Analysis of Nonpharmacological Interventions for Moderate to Severe Dementia. Psychiatry Invest. 2019;16:325-335.
Bocchetta M, Galluzzi S, Kehoe PG, et al. The use of biomarkers for the etiologic diagnosis of MCI in Europe: an EADC survey. Alzheimers Dement. 2015;11:195-206.
Porteri C, Albanese E, Scerri C, et al. The biomarker-based diagnosis of Alzheimer's disease. 1-ethical and societal issues. Neurobiol Aging. 2017;52:132-140.
Kunneman M, Pel-Littel R, Bouwman FH, et al. Patients' and caregivers' views on conversations and shared decision making in diagnostic testing for Alzheimer's disease: the ABIDE project. Alzheimers Dement (New York, N Y). 2017;3(3):314-322.
Frisoni GB, Boccardi M, Barkhof F, et al. Strategic roadmap for an early diagnosis of Alzheimer's disease based on biomarkers. Lancet Neurol. 2017;16(8):661-676.
Bossuyt PMM, McCaffery K. Additional Patient Outcomes and Pathways in Evaluations of Testing. AHRQ Methods for Effective Health Care: Medical Tests-White Paper Series. 2009.
Boccardi M, Festari C, Altomare D, et al. Assessing FDG-PET diagnostic accuracy studies to develop recommendations for clinical use in dementia. Eur J Nucl Med Mol Imaging. 2018;45(9):1470-1486.
Smailagic N, Vacante M, Hyde C, Martin S, Ukoumunne O, Sachpekidis C. (1)(8)F-FDG PET for the early diagnosis of Alzheimer's disease dementia and other dementias in people with mild cognitive impairment (MCI). Cochrane Database Syst Rev. 2015;1:Cd010632.
Smailagic N, Lafortune L, Kelly S, Hyde C, Brayne C. 18F-FDG PET for Prediction of Conversion to Alzheimer's Disease Dementia in People with Mild Cognitive Impairment: an Updated Systematic Review of Test Accuracy. J Alzheimers Dis. 2018;64(4):1175-1194.
Pepe MS, Etzioni R, Feng Z, et al. Phases of biomarker development for early detection of cancer. J Natl Cancer Inst. 2001;93(14):1054-1061.
DiSantostefano RL, Lavelle JP. The economic impact of prostate cancer screening and treatment. N C Med J. 2006;67(2):158-160.