Behavioral Science: Enhancing Our Approach to the Development of Effective Additional Risk Minimization Strategies.
Journal
Drug safety
ISSN: 1179-1942
Titre abrégé: Drug Saf
Pays: New Zealand
ID NLM: 9002928
Informations de publication
Date de publication:
09 Apr 2024
09 Apr 2024
Historique:
accepted:
07
03
2024
medline:
10
4
2024
pubmed:
10
4
2024
entrez:
9
4
2024
Statut:
aheadofprint
Résumé
Additional risk minimization strategies may be required to assure a positive benefit-risk balance for some therapeutic products associated with serious adverse drug reactions/risks of use, without which these products may be otherwise unavailable to patients. The goals of risk minimization strategies are often fundamentally to influence the behavior of healthcare professionals (HCPs) and/or patients and can include appropriate patient selection, provision of education and counselling, appropriate medication use, adverse drug reaction monitoring, and adoption of other elements to assure safe use, such as pregnancy prevention. Current approaches to additional risk minimization strategy development rely heavily on information provision, without full consideration of the contextual factors and multi-level influences on patient and HCP behaviors that impact adoption and long-term adherence to these interventions. Application of evidence-based behavioral science methods are urgently needed to improve the quality and effectiveness of these strategies. Evidence from the fields of adherence, health promotion, and drug utilization research underscores the value and necessity for using established behavioral science frameworks and methods if we are to achieve clinical safety goals for patients. The current paper aims to enhance additional risk minimization strategy development and effectiveness by considering how a behavioral science approach can be applied, drawing from evidence in understanding of engagement with pharmaceutical medicines as well as wider public health interventions for patients and HCPs.
Identifiants
pubmed: 38594553
doi: 10.1007/s40264-024-01420-w
pii: 10.1007/s40264-024-01420-w
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
Références
EMA. Guideline on good pharmacovigilance practices (GVP): Module V—risk management systems (Rev 2). EMA/838713/2011 Rev 2*. 2017.
EMA. Guideline on good pharmacovigilance practices (GVP): Module XVI Addendum I—educational materials. EMA/61341/2015. 2015.
Slatko GH. Risk evaluation and mitigation strategy (REMS): FDA perspective on what physicians need to know. Am Fam Physician. 2015;92(9):771–2.
pubmed: 26554468
Mouchantaf R, Auth D, Moride Y, Raine J, Han SY, Smith MY. Risk management for the 21st century: current status and future needs. Drug Saf. 2021;44(4):409–19. https://doi.org/10.1007/s40264-020-01033-z .
doi: 10.1007/s40264-020-01033-z
pubmed: 33565024
pmcid: 7994212
Russell A, Morrato EH, Lovett RM, Smith MY. Quality of reporting on the evaluation of risk minimization programs: a systematic review. Drug Saf. 2020;43(5):427–46. https://doi.org/10.1007/s40264-020-00905-8 .
doi: 10.1007/s40264-020-00905-8
pubmed: 32020558
Artime E, Qizilbash N, Herruzo R, Garrido-Estepa M. Risk minimisation evaluation with process indicators and behavioural or health outcomes in Europe: systematic review. Pharm Med. 2020;34(6):387–400. https://doi.org/10.1007/s40290-020-00361-w .
doi: 10.1007/s40290-020-00361-w
Vora P, Artime E, Soriano-Gabarró M, Qizilbash N, Singh V, Asiimwe A. A review of studies evaluating the effectiveness of risk minimisation measures in Europe using the European Union electronic Register of post-authorization studies. Pharmacoepidemiol Drug Saf. 2018;27(7):695–706. https://doi.org/10.1002/pds.4434 .
doi: 10.1002/pds.4434
pubmed: 29663572
pmcid: 6055865
Smith MY, Morrato E. Advancing the field of pharmaceutical risk minimization through application of implementation science best practices. Drug Saf. 2014;37(8):569–80. https://doi.org/10.1007/s40264-014-0197-0 .
doi: 10.1007/s40264-014-0197-0
pubmed: 25005707
pmcid: 4134476
Smith MY, Frise S, Feron J, Marshall R. Improving the safety of medicines via digital technology: an assessment of the scope and quality of risk minimization websites in the United States and United Kingdom. Drug Saf. 2022;45(3):259–74. https://doi.org/10.1007/s40264-022-01165-4 .
doi: 10.1007/s40264-022-01165-4
pubmed: 35247194
pmcid: 8933380
Jacquot E, Collin E, Ladner A, Tormos A, Hamm L, Perez-Gutthann S, et al. Agomelatine drug utilisation study in selected European countries: a multinational, observational study to assess effectiveness of risk-minimisation measures. Pharm Med. 2019;33(4):311–9.
doi: 10.1007/s40290-019-00291-2
Levinson DR. FDA lacks comprehensive data to determine whether risk evaluation and mitigation strategies improve drug safety: services DoHaH; 2013. Contract No.: OEI-04-11-00510.
Mazzaglia G, Straus SM, Arlett P, da Silva D, Janssen H, Raine J, et al. Study design and evaluation of risk minimization measures: a review of studies submitted to the European medicines agency for cardiovascular, endocrinology, and metabolic drugs. Drug Saf. 2018;41(2):191–202. https://doi.org/10.1007/s40264-017-0604-4 .
doi: 10.1007/s40264-017-0604-4
pubmed: 29124666
Gridchyna I, Cloutier AM, Nkeng L, Craig C, Frise S, Moride Y. Methodological gaps in the assessment of risk minimization interventions: a systematic review. Pharmacoepidemiol Drug Saf. 2014;23(6):572–9. https://doi.org/10.1002/pds.3596 . (Epub 2014 Feb 24).
doi: 10.1002/pds.3596
pubmed: 24616240
Agyemang E, Bailey L, Talbot J. Additional risk minimisation measures for medicinal products in the European Union: a review of the implementation and effectiveness of measures in the United Kingdom by one marketing authorisation holder. Pharmaceut Med. 2017;31(2):101–12. https://doi.org/10.1007/s40290-017-0184-8 . (Epub 2017 Mar 29).
doi: 10.1007/s40290-017-0184-8
pubmed: 28413313
pmcid: 5376384
Grupstra RJ, Goedecke T, Scheffers J, Strassmann V, Gardarsdottir H. Review of studies evaluating effectiveness of risk minimization measures assessed by the European Medicines Agency between 2016 and 2021. Clin Pharmacol Ther. 2023;114(6):1285–92. https://doi.org/10.1002/cpt.3034 . (Epub 2023 Oct 16).
doi: 10.1002/cpt.3034
pubmed: 37634124
Artime E, Qizilbash N, Garrido-Estepa M, Vora P, Soriano-Gabarró M, Asiimwe A, Pocock S. Are risk minimization measures for approved drugs in Europe effective? A systematic review. Expert Opin Drug Saf. 2019;18(5):443–54. https://doi.org/10.1080/14740338.2019.1612875 .
doi: 10.1080/14740338.2019.1612875
pubmed: 31032651
Da Silva-Tillmann B, Wilson MC, Doshi H, Lievano F, Perrott M, Renz C. Digital additional risk minimization measures: an exploratory study using qualitative feedback from healthcare professionals and patients across six countries. Pharm Med. 2022;36(1):21–32.
doi: 10.1007/s40290-021-00415-7
Horne R, Weinman, J, Barber N, Elliott R, Morgan M, Cribb A, et al. Concordance, adherence, and compliance in medicine taking. National Co-ordinating Centre for NHS Service Delivery and Organisation R & D (NCCSDO). December 2005.
Morrato EH. Social science theory as a framework for designing and evaluating pharmaceutical risk management dissemination and implementation strategies. In: Sprafka JM, editor. Risk management principles for devices and pharmaceuticals. 3rd ed. Rockville: Regulatory Affairs Professionals Society; 2023. (ISBN: 978-1-947493-84-1).
Bronfenbrenner U. Toward an experimental ecology of human development. Am Psychol. 1977;32(7):513–31.
doi: 10.1037/0003-066X.32.7.513
McLeroy KR, Bibeau D, Steckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Q. 1988;15(4):351–77.
doi: 10.1177/109019818801500401
pubmed: 3068205
Bahri P, Morales DR, Inoubli A, Dogné J-M, Straus SMJM. Proposals for engaging patients and healthcare professionals in risk minimisation from an analysis of stakeholder input to the EU valproate assessment using the novel analysing stakeholder safety engagement tool (ASSET). Drug Saf. 2021;44(2):193–209. https://doi.org/10.1007/s40264-020-01005-3 .
doi: 10.1007/s40264-020-01005-3
pubmed: 33125664
Smith MY, Morrato EH. Dissemination and implementation science. In: Bahri P, editor. Communicating about risks and safe use of medicines: real life and applied research. Singapore: Springer Nature Singapore Pte Ltd; 2020. p. 385–413.
Huynh L, Toyserkani GA, Morrato EH. Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA risk evaluation and mitigation strategies (REMS) (2014–2018). BMC Health Serv Res. 2021;21(1):779. https://doi.org/10.1186/s12913-021-06808-3 .
doi: 10.1186/s12913-021-06808-3
pubmed: 34362367
pmcid: 8348874
Smith MY, Russell A, Bahri P, Mol P, Frise S, Freeman E, et al. The RIMES statement: a checklist to assess the quality of studies evaluating risk minimization programs for medicinal products. Drug Saf. 2018;41(4):389–401. https://doi.org/10.1007/s40264-017-0619-x .
doi: 10.1007/s40264-017-0619-x
pubmed: 29218682
EMA. Guideline on good pharmacovigilance practices (GVP): Module XVI—risk minimisation measures: selection of tools and effectiveness indicators (Rev 3). EMA/204715/2012 Rev 3*. 2021.
Glanz K, Bishop DB. The role of behavioral science theory in development and implementation of public health interventions. Annu Rev Public Health. 2010;31:399–418.
doi: 10.1146/annurev.publhealth.012809.103604
pubmed: 20070207
Horne R, Cooper V, Wileman V, Chan A. Supporting adherence to medicines for long-term conditions: a perceptions and practicalities approach based on an extended common-sense model. Eur Psychol. 2019;24:82–96. https://doi.org/10.1027/1016-9040/a000353 .
doi: 10.1027/1016-9040/a000353
Morgan M, Horne R. Explaining patients' behaviour. In: Horne R, Weinman J, Barber N, Elliott RA, Morgan M, editors. Concordance, adherence and compliance in medicine taking: a conceptual map and research priorities. London: National Institute for Health Research (NIHR) Service Delivery and Organisation (SDO) Programme. https://www.ahpo.net/assets/NCCSDO%20Compliance%202005.pdf . Accessed 30 June 2023.
Kahneman D. Thinking, fast and slow. New York: Farrar, Straus and Giroux; 2011.
Piette JD, Heisler M, Horne R, Caleb AG. A conceptually based approach to understanding chronically ill patients’ responses to medication cost pressures. Soc Sci Med. 2006;62(4):846–57. https://doi.org/10.1016/j.socscimed.2005.06.045 .
doi: 10.1016/j.socscimed.2005.06.045
pubmed: 16095789
Horne R. Decisions about medicines: scientific evidence in contest. Academy of Medical Sciences Invited paper, 2017. https://acmedsci.ac.uk/file-download/26991434 . Accessed 30 June 2023.
Horne R, Chapman SC, Parham R, Freemantle N, Forbes A, Cooper V. Understanding patients’ adherence-related beliefs about medicines prescribed for long-term conditions: a meta-analytic review of the Necessity-Concerns Framework. PLoS ONE. 2013;8(12): e80633. https://doi.org/10.1371/journal.pone.0080633 .
doi: 10.1371/journal.pone.0080633
pubmed: 24312488
pmcid: 3846635
Foot H, La Caze A, Gujral G, Cottrell N. The necessity-concerns framework predicts adherence to medication in multiple illness conditions: a meta-analysis. Patient Educ Couns. 2016;99(5):706–17. https://doi.org/10.1016/j.pec.2015.11.004 .
doi: 10.1016/j.pec.2015.11.004
pubmed: 26613666
Horne R, Coombes I, Davies G, Hankins M, Vincent R. Barriers to optimum management of heart failure by general practitioners. Br J Gen Pract. 1999;49(442):353–7.
pubmed: 10736884
pmcid: 1313419
Cabana MD, Rand CS, Powe NR, Wu AW, Wilson MH, Abboud PA, et al. Why don’t physicians follow clinical practice guidelines? A framework for improvement. JAMA. 1999;282(15):1458–65. https://doi.org/10.1001/jama.282.15.1458 .
doi: 10.1001/jama.282.15.1458
pubmed: 10535437
Casey DE Jr. Why don’t physicians (and patients) consistently follow clinical practice guidelines? JAMA Intern Med. 2013;173(17):1581–3. https://doi.org/10.1001/jamainternmed.2013.7672 .
doi: 10.1001/jamainternmed.2013.7672
pubmed: 23897435
Desveaux L, Saragosa M, Kithulegoda N, Ivers NM. Understanding the behavioural determinants of opioid prescribing among family physicians: a qualitative study. BMC Fam Pract. 2019;20(1):59. https://doi.org/10.1186/s12875-019-0947-2 .
doi: 10.1186/s12875-019-0947-2
pubmed: 31077137
pmcid: 6511163
Guastella V, Delorme J, Chenaf C, Authier N. The prevalence of off-label prescribing of transmucosal immediate-release fentanyl in France. J Pain Symptom Manag. 2022;63(6):980–7. https://doi.org/10.1016/j.jpainsymman.2022.02.016 .
doi: 10.1016/j.jpainsymman.2022.02.016
Horne R, Weinman J, Hankins M. The Beliefs about Medicines Questionnaire: the development and evaluation of a new method for assessing the cognitive representation of medication. Psychol Health. 1999;14:1–24. https://doi.org/10.1080/08870449908407311 .
doi: 10.1080/08870449908407311
Collins M-K, Moreau JF, Opel D, Swan J, Prevost N, Hastings M, et al. Compliance with pregnancy prevention measures during isotretinoin therapy. J Am Acad Dermatol. 2014;70(1):55–9. https://doi.org/10.1016/j.jaad.2013.08.034 .
doi: 10.1016/j.jaad.2013.08.034
pubmed: 24157382
Molloy GJ, Graham H, McGuinness H. Adherence to the oral contraceptive pill: a cross-sectional survey of modifiable behavioural determinants. BMC Public Health. 2012;12:838. https://doi.org/10.1186/1471-2458-12-838 .
doi: 10.1186/1471-2458-12-838
pubmed: 23031437
pmcid: 3491039
Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci. 2015;10:53. https://doi.org/10.1186/s13012-015-0242-0 .
doi: 10.1186/s13012-015-0242-0
pubmed: 25895742
pmcid: 4406164
Francis JJ, O’Connor D, Curran J. Theories of behaviour change synthesised into a set of theoretical groupings: introducing a thematic series on the theoretical domains framework. Implement Sci. 2012;7:35. https://doi.org/10.1186/1748-5908-7-35 .
doi: 10.1186/1748-5908-7-35
pubmed: 22531601
pmcid: 3444902
Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6:42. https://doi.org/10.1186/1748-5908-6-42 .
doi: 10.1186/1748-5908-6-42
pubmed: 21513547
pmcid: 3096582
Yardley L, Morrison L, Bradbury K, Muller I. The person-based approach to intervention development: application to digital health-related behavior change interventions. J Med Internet Res. 2015;17(1):e30. https://doi.org/10.2196/jmir.4055 .
doi: 10.2196/jmir.4055
pubmed: 25639757
pmcid: 4327440
Green L, Kreuter M. Health promotion planning: an educational and environmental approach. 2nd ed. Mountain View: Mayfield Publishing Company; 1991.
Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, et al. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021;374: n2061. https://doi.org/10.1136/bmj.n2061 .
doi: 10.1136/bmj.n2061
pubmed: 34593508
pmcid: 8482308
Fishbein M, Triandis HC, Kanfer FH, Becker M, Middlestadt SE, Eichler A. Factors influencing behaviour and behaviour change. In: Baum A, Revenson TA, Singer JE, editors. Handbook of health psychology. Mahwah: Lawrence Erlbaum Associates; 2001. p. 3–17.
Horne R, Weinman J. Patients’ beliefs about prescribed medicines and their role in adherence to treatment in chronic physical illness. J Psychosom Res. 1999;47(6):555–67.
doi: 10.1016/S0022-3999(99)00057-4
pubmed: 10661603
Aujla N, Walker MF, Sprigg N, Abrams KR, Massey A, Vedhara K. Can illness beliefs, from the common-sense model, prospectively predict adherence to self-management behaviours? A systematic review and meta-analysis. Psychol Health. 2016;31:931–58.
doi: 10.1080/08870446.2016.1153640
pubmed: 26911306
Davis R, Campbell R, Hildon Z, Hobbs L, Michie S. Theories of behaviour and behaviour change across the social and behavioural sciences: a scoping review. Health Psychol Rev. 2015;9(3):323–44. https://doi.org/10.1080/17437199.2014.941722 . (Epub 2014 Aug 8).
doi: 10.1080/17437199.2014.941722
pubmed: 25104107
Michie S, West R, Sheals K, Godinho CA. Evaluating the effectiveness of behavior change techniques in health-related behavior: a scoping review of methods used. Transl Behav Med. 2018;8(2):212–24.
doi: 10.1093/tbm/ibx019
pubmed: 29381786
pmcid: 6062857
French SD, Green SE, O’Connor DA, McKenzie JE, Francis JJ, Michie S, Buchbinder R, Schattner P, Spike N, Grimshaw JM. Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework. Implement Sci. 2012;24(7):38. https://doi.org/10.1186/1748-5908-7-38.PMID:22531013;PMCID:PMC3443064 .
doi: 10.1186/1748-5908-7-38.PMID:22531013;PMCID:PMC3443064
Sinnott C, Mercer SW, Payne RA, Duerden M, Bradley CP, Byrne M. Improving medication management in multimorbidity: development of the MultimorbiditY COllaborative Medication Review And DEcision Making (MY COMRADE) intervention using the behaviour change wheel. Implement Sci. 2015;10:132.
doi: 10.1186/s13012-015-0322-1
pubmed: 26404642
pmcid: 4582886
Public Health England. Research and analysis: Chapter 6: social determinants of health. 13 Jul 2017. https://www.gov.uk/government/publications/health-profile-for-england/chapter-6-social-determinants-of-health . Accessed 30 June 2023.
Bailey SC, Opsasnick LA, Curtis LM, Federman AD, Benavente JY, O’Conor R, et al. Longitudinal investigation of older adults’ ability to self-manage complex drug regimens. J Am Geriatr Soc. 2020;68(3):569–75. https://doi.org/10.1111/jgs.16255 .
doi: 10.1111/jgs.16255
pubmed: 31765007
Perry JE, Cox D, Cox AD. Trust and transparency: patient perceptions of physicians’ financial relationships with pharmaceutical companies. J Law Med Ethics. 2014;42(4):475–91. https://doi.org/10.1111/jlme.12169 .
doi: 10.1111/jlme.12169
pubmed: 25565614
Murphy J, Vallières F, Bentall R, Shevlin M, McBride O, Hartman T, et al. Psychological characteristics associated with COVID-19 vaccine hesitancy and resistance in Ireland and the United Kingdom. Nat Commun. 2021. https://doi.org/10.1038/s41467-020-20226-9 .
doi: 10.1038/s41467-020-20226-9
pubmed: 34916495
pmcid: 8677800
Jaiswal J. Whose responsibility is it to dismantle medical mistrust? Future directions for researchers and health care providers. Behave Med. 2019;45(2):188–96. https://doi.org/10.1080/08964289.2019.1630357 .
doi: 10.1080/08964289.2019.1630357
O’Carroll RE, Chambers JA, Dennis M, Sudlow C, Johnston M. Improving adherence to medication in stroke survivors: a pilot randomised controlled trial. Ann Behav Med. 2013;46(3):358–68.
doi: 10.1007/s12160-013-9515-5
pubmed: 23670112
Clifford S, Barber N, Elliott RA, Hartley E, Horne R. Patient-centred advice is effective in improving adherence to medicines. Pharm World Sci. 2006;28(3):165–70. https://doi.org/10.1007/s11096-006-9026-6 .
doi: 10.1007/s11096-006-9026-6
pubmed: 17004019
Odeh M, Scullin C, Fleming G, Scott MG, Horne R, McElnay JC. Ensuring continuity of patient care across the healthcare interface: telephone follow-up post-hospitalization. Br J Clin Pharmacol. 2019;85(3):616–25. https://doi.org/10.1111/bcp.13839 .
doi: 10.1111/bcp.13839
pubmed: 30675742
pmcid: 6379220
Michie S, Richardson M, Johnston M, Abraham C, Francis J, Hardeman W, et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: building an international consensus for the reporting of behavior change interventions. Ann Behav Med. 2013;46(1):81–95. https://doi.org/10.1007/s12160-013-9486-6 .
doi: 10.1007/s12160-013-9486-6
pubmed: 23512568
Gallagher KM, Updegraff JA. Health message framing effects on attitudes, intentions, and behavior: a meta-analytic review. Ann Behav Med. 2012;43(1):101–16. https://doi.org/10.1007/s12160-011-9308-7 .
doi: 10.1007/s12160-011-9308-7
pubmed: 21993844
Zeng Y, Shi L, Liu C, Li W, Li J, Yang S, et al. Effects of social norm feedback on antibiotic prescribing and its characteristics in behaviour change techniques: a mixed-methods systematic review. Lancet Infect Dis. 2022;S1473–3099(22):00720–4. https://doi.org/10.1016/S1473-3099(22)00720-4 .
doi: 10.1016/S1473-3099(22)00720-4
Gollwitzer PM, Sheeran P. Implementation intentions and goal achievement: a meta-analysis of effects and processes. Adv Exp Soc Psychol. 2006;38:69–119. https://doi.org/10.1016/S0065-2601(06)38002-1 .
doi: 10.1016/S0065-2601(06)38002-1
Hobbs N, Sniehotta FF. Two-year findings of an implementation intention intervention for teenage women show reduced consultations for emergency contraception or pregnancy testing and a trend towards reduced pregnancy rates. Evid-Based Nurs. 2012;15(2):44–5. https://doi.org/10.1136/ebnurs.2011.100192 .
doi: 10.1136/ebnurs.2011.100192
pubmed: 22187499
Martin J, Sheeran P, Slade P, Wright A, Dibble T. Implementation intention formation reduces consultations for emergency contraception and pregnancy testing among teenage women. Health Psychol. 2009;28:762–9. https://doi.org/10.1037/a0016200 .
doi: 10.1037/a0016200
pubmed: 19916645
Sabesan S, Allen D, Caldwell P, Loh PK, Mozer R, Komesaroff PA, et al. Practical aspects of telehealth: doctor–patient relationship and communication. Intern Med J. 2014;44:101–3. https://doi.org/10.1111/imj.12323 .
doi: 10.1111/imj.12323
pubmed: 24450527
Rotenstein LS, Friedman LS. The pitfalls of telehealth—and how to avoid them. Harvard Bus Rev. 2020. https://hbr.org/2020/11/the-pitfalls-of-telehealth-and-how-to-avoid-them . Accessed 10 Mar 2023.
Mohammad I, Korkis B, Garwood CL. Incorporating comprehensive management of direct oral anticoagulants into anticoagulation clinics. Pharmacotherapy. 2017;37(10):1284–97. https://doi.org/10.1002/phar.1991 .
doi: 10.1002/phar.1991
pubmed: 28730690
Conway SE, Hwang AY, Ponte CD, Gums JG. Laboratory and clinical monitoring of direct acting oral anticoagulants: what clinicians need to know. Pharmacotherapy. 2017;37(2):236–48. https://doi.org/10.1002/phar.1884 .
doi: 10.1002/phar.1884
pubmed: 27983747
Chapman S, Sibelli A, St-Clair Jones A, Forbes A, Chater A, Horne R. Personalised adherence support for maintenance treatment of inflammatory bowel disease: a tailored digital intervention to change adherence-related beliefs and barriers. J Crohns Colitis. 2020;14(10):1394–404. https://doi.org/10.1093/ecco-jcc/jjz034 .
doi: 10.1093/ecco-jcc/jjz034
pubmed: 32379303
Nguyen MH, van Weert JCM, Bol N, Loos EF, Tytgat KMAJ, van de Ven AWH, et al. Tailoring the mode of information presentation: effects on younger and older adults’ attention and recall of online information. Hum Commun Res. 2017;43(1):102–26. https://doi.org/10.1111/hcre.12097 .
doi: 10.1111/hcre.12097
Nguyen MH, Bol N, King AJ. Customization versus personalisation of digital health information: effects of mode tailoring on information processing outcomes. Eur J Health Commun. 2020;1(1):30–54. https://doi.org/10.47368/ejhc.2020.003 .
doi: 10.47368/ejhc.2020.003
Carlisle S, Ayling K, Jia R, Buchanan H, Vedhara K. The effect of choice interventions on retention-related, behavioural and mood outcomes: a systematic review with meta-analysis. Health Psychol Rev. 2022;16(2):220–56. https://doi.org/10.1080/17437199.2021.1962386 .
doi: 10.1080/17437199.2021.1962386
pubmed: 34423744
National Institute for Health and Care Excellence. Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence. Clinical guideline [CG76] 2009. https://www.nice.org.uk/guidance/cg76 . Accessed 30 June 2023.
Morrato EH, Smith MY. Integrating risk minimization planning throughout the clinical development and commercialization lifecycle: an opinion on how drug development could be improved. Ther Clin Risk Manag. 2015;11:339–48. https://doi.org/10.2147/TCRM.S78202 .
doi: 10.2147/TCRM.S78202
pubmed: 25750537
pmcid: 4348129
Brown P, Bahri P. ‘Engagement’ of patients and healthcare professionals in regulatory pharmacovigilance: establishing a conceptual and methodological framework. Eur J Clin Pharmacol. 2019;75(9):1181–92.
doi: 10.1007/s00228-019-02705-1
pubmed: 31240364
Morrato EH. Implementation science: ensuring the return on our research investment. Neurorehabil Neural Repair. 2018;32(9):762–4. https://doi.org/10.1177/1545968318794904 . (Epub 2018 Aug 21).
doi: 10.1177/1545968318794904
pubmed: 30129390
pmcid: 6404530
Smith MY, Morrato EH. Dissemination and implementation science. In: Bahri P, editor. Communicating about risks and safe use of medicines: real life and applied research. Berlin: Springer; 2020.
Sacristán JA, Artime E, Díaz-Cerezo S, Comellas M, Pérez-Carbonell L, Lizán L. The impact of patient support programs in Europe: a systematic literature review. Patient. 2022;15(6):641–54. https://doi.org/10.1007/s40271-022-00582-y .
doi: 10.1007/s40271-022-00582-y
pubmed: 35725866
pmcid: 9584873