Dissemination and Implementation Science

  • Elaine H. MorratoEmail author
  • Meredith Y. Smith


The dissemination and implementation of health interventions is the active and targeted distribution of information and intervention materials to a specific public health, healthcare professional or patient audience with the goal of transferring knowledge and/or promoting changes in health attitudes and behaviours. In this chapter, we present key tenets of effective health dissemination and implementation in the context of medicinal product risk minimisation and communication. We review best practices and recommendations from dissemination and implementation (D&I) science and discuss their application to risk minimisation programme design, implementation and evaluation stages. To illustrate these concepts, we examine the evolution of the valproate risk minimisation programme in Europe.


  1. Agency for Healthcare Research and Quality. Health Literacy Measurement Tools (Revised) [updated February 2016]. Available from:
  2. Albright K, Gechter K, Kempe A (2013) Importance of mixed methods in pragmatic trials and dissemination and implementation research. Acad Pediatr 13(5):400–407PubMedCrossRefGoogle Scholar
  3. Alrwisan AA, Wei YJ, Brumback BA, Antonelli PJ, Winterstein AG (2019) Concomitant use of quinolones and stimulants and the risk of adverse cardiovascular symptoms: a retrospective cohort study. PharmacotherapyGoogle Scholar
  4. Ancker JS, Senathirajah Y, Kukafka R, Starren JB (2006) Design features of graphs in health risk communication: a systematic review. J Am Med Inform Assoc 13(6):608–618PubMedPubMedCentralCrossRefGoogle Scholar
  5. ASQ (2015) ASQ/ANSI/ISO 9000:2015: quality management systems - fundamentals and vocabulary. American Society for Quality, MilwaukeeGoogle Scholar
  6. BBC News (2017) New evidence in France of harm from epilepsy drug valproate. April 20, 2017Google Scholar
  7. Bian J, Chen B, Hershman DL, Marks N, Norris L, Schulz R et al (2017) Effects of the US food and drug administration boxed warning of erythropoietin-stimulating agents on utilization and adverse outcome. J Clin Oncol 35(17):1945–1951PubMedPubMedCentralCrossRefGoogle Scholar
  8. Birken SA, Powell BJ, Presseau J, Kirk MA, Lorencatto F, Gould NJ et al (2017) Combined use of the Consolidated Framework for Implementation Research (CFIR) and the Theoretical Domains Framework (TDF): a systematic review. Implement Sci 12(1):2PubMedPubMedCentralCrossRefGoogle Scholar
  9. Brewer NT (2011) Goals. In: Fischoff B, Brewer NT, Downs JS (eds) Communicating risks and benefits: an evidence-based user’s guide. Food and Drug Administration, U.S. Department of Health and Human Services, Silver Spring, pp 3–10Google Scholar
  10. Brewer SE, Campagna EJ, Morrato EH (2019) Advancing regulatory science and assessment of FDA REMS programs: a mixed-methods evaluation examining physician survey response. J Clin Transl Sci 3(4):199–209PubMedPubMedCentralCrossRefGoogle Scholar
  11. Brown P, Bahri P (2019) ‘Engagement’ of patients and healthcare professionals in regulatory pharmacovigilance: establishing a conceptual and methodological framework. Eur J Clin Pharmacol 75(9):1181–1192PubMedCrossRefGoogle Scholar
  12. Brownson RC, Jacobs JA, Tabak RG, Hoehner CM, Stamatakis KA (2013) Designing for dissemination among public health researchers: findings from a national survey in the United States. Am J Public Health 103(9):1693–1699PubMedPubMedCentralCrossRefGoogle Scholar
  13. Brownson RC, Colditz GA, Proctor EK (eds) (2017) Dissemination and implementation research in health: translating science to practice, 2nd edn. Oxford University Press, New YorkGoogle Scholar
  14. Brownson RC, Fielding JE, Green LW (2018) Building capacity for evidence-based public health: reconciling the pulls of practice and the push of research. Annu Rev Public Health 39:27–53PubMedCrossRefGoogle Scholar
  15. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research (2011) In: US Department of Health and Human Services (ed) Guidance medication guides -- distribution requirements and inclusion in Risk Evaluation and Mitigation Strategies (REMS)Google Scholar
  16. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research (2019a) In: US Department of Health and Human Services (ed) REMS assessment: planning and reporting. Guidance for industry (draft guidance). Food and Drug Administration, Silver SpringGoogle Scholar
  17. Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research (2019b) In: US Department of Health and Human Services (ed) Survey methodologies to assess REMS goals that relate to knowledge. Guidance to industry (draft guidance)Google Scholar
  18. Centers for Disease Control and Prevention (2018) Writing smart objectives. Available from:
  19. Chambers DA (2019) Sharpening our focus on designing for dissemination: lessons from the SPRINT program and potential next steps for the field. Transl Behav MedGoogle Scholar
  20. Chambers DA, Norton WE (2016) The adaptome: advancing the science of intervention adaptation. Am J Prev Med 51(4 Suppl 2):S124–S131PubMedPubMedCentralCrossRefGoogle Scholar
  21. Chan HW, Russell AM, Smith MY (2018) What is the quality of drug safety information for patients: an analysis of REMS educational materials. Pharmacoepidemiol Drug Saf 27(9):969–978PubMedPubMedCentralCrossRefGoogle Scholar
  22. Committee on Risk Perception and Communication (1989) Improving risk communication. The National Academies Press, Washington, D.C.Google Scholar
  23. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC (2009) Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science. Implement Sci 4:50PubMedPubMedCentralCrossRefGoogle Scholar
  24. Dearing JW, Cox JG (2018) Diffusion of innovations theory, principles, and practice. Health Aff (Millwood) 37(2):183–190CrossRefGoogle Scholar
  25. Dearing JW, Smith DK, Larson RS, Estabrooks CA (2013) Designing for diffusion of a biomedical intervention. Am J Prev Med 44(1 Suppl 2):S70–S76PubMedCrossRefGoogle Scholar
  26. European Medicines Agency. PRAC recommends strengthening the restrictions on the use of valproate in women and girls [press release]. October 10, 2014Google Scholar
  27. European Medicines Agency and Heads of Medicines Agencies (2015a) Guideline on Good Pharmacovigilance Practices (GVP) Module XVI Addendum I - educational materialsGoogle Scholar
  28. European Medicines Agency and Heads of Medicines Agencies (2015b) Guideline on Good Pharmacovigilance Practices (GVP) Module XVI - risk minimisation measures: selection of tools and effectiveness indicators (Rev 2)Google Scholar
  29. European Medicines Agency and Heads of Medicines Agencies (2017a) Guideline on Good Pharmacovigilance Practices (GVP) Module V - risk management systems (Rev 2)Google Scholar
  30. European Medicines Agency and Heads of Medicines Agencies (2017b) Guideline on Good Pharmacovigilance Practices (GVP) Module XV - safety communication (Rev 1)Google Scholar
  31. European Medicines Agency and Heads of Medicines Agencies (2017c) Guideline on Good Pharmacovigilance Practices (GVP) Annex I - definitions (Rev 4)Google Scholar
  32. European Medicines Agency and Heads of Medicines Agencies (2017d) Summary of the EMA public hearing on valproate in pregnancyGoogle Scholar
  33. European Medicines Agency and Heads of Medicines Agencies (2018a) New measures to avoid valproate exposure in pregnancy endorsed. Member State representatives agree new restrictions and pregnancy prevention programmeGoogle Scholar
  34. European Medicines Agency and Heads of Medicines Agencies (2018b) Public hearing on valproate: written interventionsGoogle Scholar
  35. Field TS, Cadoret CA, Brown ML, Ford M, Greene SM, Hill D et al (2002) Surveying physicians: do components of the “Total Design Approach” to optimizing survey response rates apply to physicians? Med Care 40(7):596–605PubMedCrossRefGoogle Scholar
  36. Fischoff B, Brewer NT, Downs JS (eds) (2011) Communicating risks and benefits: an evidence-based user’s guide. Food and Drug Administration, U.S. Department of Health and Human Services, Silver SpringGoogle Scholar
  37. Gellad ZF, Day TE (2016) What is value stream mapping, and how can it help my practice? Am J Gastroenterol 111(4):447–448PubMedPubMedCentralCrossRefGoogle Scholar
  38. Glasgow RE, Chambers D (2012) Developing robust, sustainable, implementation systems using rigorous, rapid and relevant science. Clin Transl Sci 5(1):48–55PubMedPubMedCentralCrossRefGoogle Scholar
  39. Glasgow RE, Vinson C, Chambers D, Khoury MJ, Kaplan RM, Hunter C (2012) National Institutes of Health approaches to dissemination and implementation science: current and future directions. Am J Public Health 102(7):1274–1281PubMedPubMedCentralCrossRefGoogle Scholar
  40. Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC et al (2019) RE-AIM planning and evaluation framework: adapting to new science and practice with a 20-year review. Front Public Health 7:64PubMedPubMedCentralCrossRefGoogle Scholar
  41. Glasziou P, Haynes B (2005) The paths from research to improved health outcomes. ACP J Club 142(2):A8–A10PubMedGoogle Scholar
  42. Green L, Kreuter M (2005) Health program planning: an educational and ecological approach, 4th edn. McGraw Hill, New YorkGoogle Scholar
  43. Green LW, Ottoson JM, Garcia C, Hiatt RA (2009) Diffusion theory and knowledge dissemination, utilization, and integration in public health. Annu Rev Public Health 30:151–174PubMedCrossRefGoogle Scholar
  44. Green CA, Duan N, Gibbons RD, Hoagwood KE, Palinkas LA, Wisdom JP (2015) Approaches to mixed methods dissemination and implementation research: methods, strengths, caveats, and opportunities. Adm Policy Ment Health 42(5):508–523PubMedPubMedCentralCrossRefGoogle Scholar
  45. Handley MA, Lyles CR, McCulloch C, Cattamanchi A (2018) Selecting and improving quasi-experimental designs in effectiveness and implementation research. Annu Rev Public Health 39:5–25PubMedCrossRefGoogle Scholar
  46. Harel Z, Silver SA, McQuillan RF, Weizman AV, Thomas A, Chertow GM et al (2016) How to diagnose solutions to a quality of care problem. Clin J Am Soc Nephrol 11(5):901–907PubMedPubMedCentralCrossRefGoogle Scholar
  47. Harris JR, Cheadle A, Hannon PA, Forehand M, Lichiello P, Mahoney E et al (2012) A framework for disseminating evidence-based health promotion practices. Prev Chronic Dis 9:E22PubMedCrossRefGoogle Scholar
  48. Ho K, Peter Wall Workshop P (2014) Harnessing the social web for health and wellness: issues for research and knowledge translation. J Med Internet Res 16(2):e34PubMedPubMedCentralCrossRefGoogle Scholar
  49. Huebschmann AG, Leavitt IM, Glasgow RE (2019) Making health research matter: a call to increase attention to external validity. Annu Rev Public Health 40:45–63PubMedCrossRefGoogle Scholar
  50. Institute of Medicine Committee on Quality of Health Care in America (2001) Crossing the quality chasm: a new health system for the 21st century. National Academies Press (US), Washington (DC)Google Scholar
  51. Issen L, Woodcock T, McNicholas C, Lennox L, Reed JE (2018) Criteria for evaluating programme theory diagrams in quality improvement initiatives: a structured method for appraisal. Int J Qual Health Care 30(7):508–513PubMedPubMedCentralCrossRefGoogle Scholar
  52. Keith RE, Crosson JC, O’Malley AS, Cromp D, Taylor EF (2017) Using the Consolidated Framework for Implementation Research (CFIR) to produce actionable findings: a rapid-cycle evaluation approach to improving implementation. Implement Sci 12(1):15PubMedPubMedCentralCrossRefGoogle Scholar
  53. Knox C, Hampp C, Willy M, Winterstein AG, Dal Pan G (2015) Patient understanding of drug risks: an evaluation of medication guide assessments. Pharmacoepidemiol Drug Saf 24(5):518–525PubMedPubMedCentralCrossRefGoogle Scholar
  54. Kreuter MW, Wang ML (2015) From evidence to impact: recommendations for a dissemination support system. New Dir Child Adolesc Dev 2015(149):11–23PubMedPubMedCentralCrossRefGoogle Scholar
  55. Leong Wai Yeen J, Salek S, Walker S (2014) Strategy for communicating benefit-risk decisions: a comparison of regulatory agencies’ publicly available documents. Front Pharmacol 5:269PubMedPubMedCentralCrossRefGoogle Scholar
  56. McGettigan P, Alonso Olmo C, Plueschke K, Castillon M, Nogueras Zondag D, Bahri P et al (2019) Patient registries: an underused resource for medicines evaluation: operational proposals for increasing the use of patient registries in regulatory assessments. Drug SafGoogle Scholar
  57. Morrato EH (2018) Social science theory as a framework for designing and evaluating pharmaceutical risk mitigation dissemination and implementation strategies. In: Sietsema WK, Sprafka JM (eds) Risk management principles for devices and pharmaceuticals: global perspectives on the benefit: risk assessment of medicinal products, 2nd edn. Regulatory Affairs Professional Society, RockvilleGoogle Scholar
  58. Morrato EH, Libby AM, Orton HD, Degruy FV 3rd, Brent DA, Allen R et al (2008) Frequency of provider contact after FDA advisory on risk of pediatric suicidality with SSRIs. Am J Psychiatry 165(1):42–50PubMedCrossRefGoogle Scholar
  59. Morrato EH, Brewer SE, Campagna EJ, Dickinson LM, Thomas DS, Druss BG et al (2016) Glucose testing for adults receiving Medicaid and antipsychotics: a population-based prescriber survey on behaviors, attitudes, and barriers. Psychiatr Serv 67(7):798–802PubMedPubMedCentralCrossRefGoogle Scholar
  60. Morris JK, Garne E, Loane M, Addor MC, Barisic I, Bianchi F et al (2018) Prevalence of valproate syndrome in Europe from 2005 to 2014: a registry based multi-centre study. Eur J Med Genet 61(9):479–482PubMedCrossRefGoogle Scholar
  61. Muhlbacher AC, Juhnke C, Beyer AR, Garner S (2016) Patient-focused benefit-risk analysis to inform regulatory decisions: the European Union perspective. Value Health 19(6):734–740PubMedCrossRefGoogle Scholar
  62. Nilsen P (2015) Making sense of implementation theories, models and frameworks. Implement Sci 10(1)Google Scholar
  63. Nilsen P, Bernhardsson S (2019) Context matters in implementation science: a scoping review of determinant frameworks that describe contextual determinants for implementation outcomes. BMC Health Serv Res 19(1):189PubMedPubMedCentralCrossRefGoogle Scholar
  64. Office of the Associate Director for Communications (2016) In: U.S. Department of Health and Human Services (ed) Everyday words for public health communicationGoogle Scholar
  65. Prieto L, Spooner A, Hidalgo-Simon A, Rubino A, Kurz X, Arlett P (2012) Evaluation of the effectiveness of risk minimization measures. Pharmacoepidemiol Drug Saf 21(8):896–899PubMedCrossRefGoogle Scholar
  66. Proctor EK, Powell BJ, Baumann AA, Hamilton AM, Santens RL (2012) Writing implementation research grant proposals: ten key ingredients. Implement Sci 7(1):96PubMedPubMedCentralCrossRefGoogle Scholar
  67. Rabin BA, Brownson RC (2017) Terminology for dissemination and implementation research. In: Brownson RC, Colditz GA, Proctor EK (eds) Dissemination and implementation research in health: translating science to practice, 2nd edn. Oxford University Press, New York, pp 19–45Google Scholar
  68. Radawski C, Morrato E, Hornbuckle K, Bahri P, Smith M, Juhaeri J et al (2015) Benefit-Risk Assessment, Communication, and Evaluation (BRACE) throughout the life cycle of therapeutic products: overall perspective and role of the pharmacoepidemiologist. Pharmacoepidemiol Drug Saf 24(12):1233–1240PubMedPubMedCentralCrossRefGoogle Scholar
  69. Ramsey AT, Proctor EK, Chambers DA, Garbutt JM, Malone S, Powderly WG et al (2019) Designing for Accelerated Translation (DART) of emerging innovations in health. J Clin Transl Sci 3(2–3):53–58PubMedPubMedCentralCrossRefGoogle Scholar
  70. Reed JE, McNicholas C, Woodcock T, Issen L, Bell D (2014) Designing quality improvement initiatives: the action effect method, a structured approach to identifying and articulating programme theory. BMJ Qual Saf 23(12):1040–1048PubMedCrossRefGoogle Scholar
  71. Ritzwoller DP, Sukhanova A, Gaglio B, Glasgow RE (2009) Costing behavioral interventions: a practical guide to enhance translation. Ann Behav Med 37(2):218–227PubMedCrossRefGoogle Scholar
  72. Rosstad T, Garasen H, Steinsbekk A, Haland E, Kristoffersen L, Grimsmo A (2015) Implementing a care pathway for elderly patients, a comparative qualitative process evaluation in primary care. BMC Health Serv Res 15:86PubMedPubMedCentralCrossRefGoogle Scholar
  73. Shelton RC, Cooper BR, Stirman SW (2018) The sustainability of evidence-based interventions and practices in public health and health care. Annu Rev Public Health 39:55–76PubMedCrossRefGoogle Scholar
  74. Smith MY, Raynor DKT. Improving the effectiveness of drug safety measures in the EU: the public hearing on valproate. BMC Health Serv Res (in press)Google Scholar
  75. Smith MY, Morrato EH (2014) Advancing the field of pharmaceutical risk minimization through application of implementation science best practices. Drug Saf 37(8):569–580PubMedPubMedCentralCrossRefGoogle Scholar
  76. Smith ZR, Makowski CT, MacDonald NC (2017) Inpatient pharmacy experience with an audit for a risk evaluation and mitigation strategy for riociguat. Am J Health Syst Pharm 74(21):1762–1763PubMedCrossRefGoogle Scholar
  77. Smith MY, Russell A, Bahri P, Mol PGM, Frise S, Freeman E et al (2018) The RIMES Statement: a checklist to assess the quality of studies evaluating risk minimization programs for medicinal products. Drug Saf 41(4):389–401PubMedCrossRefGoogle Scholar
  78. Tabak RG, Khoong EC, Chambers DA, Brownson RC (2012) Bridging research and practice: models for dissemination and implementation research. Am J Prev Med 43(3):337–350PubMedPubMedCentralCrossRefGoogle Scholar
  79. Tkachenko E, Singer S, Sharma P, Barbieri J, Mostaghimi A (2019) US food and drug administration reports of pregnancy and pregnancy-related adverse events associated with isotretinoin. JAMA DermatolGoogle Scholar
  80. Trevena LJ, Zikmund-Fisher BJ, Edwards A, Gaissmaier W, Galesic M, Han PKJ et al (2013) Presenting quantitative information about decision outcomes: a risk communication primer for patient decision aid developers. BMC Med Inform Decis Mak 13(S2)Google Scholar
  81. Westfall JM, Zittleman L, Felzien M, Norman N, Tamez M, Backlund-Jarquin P et al (2016) Reinventing the wheel of medical evidence: how the boot camp translation process is making gains. Health Aff (Millwood) 35(4):613–618CrossRefGoogle Scholar
  82. Willy ME, Graham DJ, Racoosin JA, Gill R, Kropp GF, Young J et al (2014) Candidate metrics for evaluating the impact of prescriber education on the safe use of extended-release/long-acting (ER/LA) opioid analgesics. Pain Med 15(9):1558–1568PubMedCrossRefGoogle Scholar
  83. Wiltsey Stirman S, Baumann AA, Miller CJ (2019) The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions. Implement Sci 14(1):58PubMedPubMedCentralCrossRefGoogle Scholar

Copyright information

© Springer Nature Singapore Pte Ltd. 2020

Authors and Affiliations

  1. 1.Parkinson School of Health Sciences and Public Health, Loyola University ChicagoChicagoUSA
  2. 2.Colorado School of Public Health, University of Colorado Anschutz Medical CampusAuroraUSA
  3. 3.Alexion Pharmaceuticals, Inc.BostonUSA
  4. 4.School of Pharmacy, University of Southern CaliforniaLos AngelesUSA

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