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Co-creation of patient engagement quality guidance for medicines development: an international multistakeholder initiative
  1. Katherine Deane1,
  2. Laure Delbecque2,
  3. Oleksandr Gorbenko3,
  4. Anne Marie Hamoir4,
  5. Anton Hoos4,
  6. Begonya Nafria5,
  7. Chi Pakarinen4,
  8. Ify Sargeant4,
  9. Dawn P Richards6,
  10. Soren Eik Skovlund7,
  11. Nicholas Brooke4
  12. on behalf of the PFMD Patient Engagement Meta-framework Co-creation Team
    1. 1 School of Health Sciences, University of East Anglia, Norwich, UK
    2. 2 Patient Reported Outcomes, Pharmerit International, Rotterdam, Belgium
    3. 3 Chief Scientific and Medical Office – Patient Affairs, ViiV Healthcare, London, UK
    4. 4 Patient Focused Medicines Development, Brussels, Belgium
    5. 5 Patient Engagement in Research, Institut de Recerca Sant Joan de Déu- Hospital Sant Joan de Déu, Esplugues de Llobregat, Spain
    6. 6 Clinical Trials Ontario, Toronto, Ontario, Canada
    7. 7 Steno Diabetes Centre North Denmark, Aalborg University Hospital, Aalborg, Denmark
    1. Correspondence to Anne Marie Hamoir, Patient Focused Medicines Development, Brussels 1050, Belgium; am.hamoir{at}


    Introduction Meaningful patient engagement (PE) can enhance medicines’ development. However, the current PE landscape is fragmentary and lacking comprehensive guidance.

    Methods We systematically searched for PE initiatives (SYNaPsE database/publications). Multistakeholder groups integrated these with their own PE expertise to co-create draft PE Quality Guidance which was evaluated by public consultation. Projects exemplifying good PE practice were identified and assessed against PE Quality Criteria to create a Book of Good Practices (BOGP).

    Results Seventy-six participants from 51 organisations participated in nine multistakeholder meetings (2016–2018). A shortlist of 20relevant PE initiatives (from 170 screened) were identified. The co-created INVOLVE guidelines provided the main framework for PE Quality Guidance and was enriched with the analysis of the PE initiatives and the PE expertise of stakeholders. Seven key PE Quality Criteria were identified. Public consultation yielded 67 responses from diverse backgrounds. The PE Quality Guidance was agreed to be useful for achieving quality PE in practice, understandable, easy to use, and comprehensive. Overall, eight initiatives from the shortlist and from meeting participants were selected for inclusion in the BOGP based on demonstration of PE Quality Criteria and willingness of initiative owners to collaborate.

    Discussion The PE Quality Guidance and BOGP are practical resources which will be continually updated in response to user feedback. They are not prescriptive, but rather based on core principles, which can be applied according to the unique needs of each interaction and initiative. Implementation of the guidance will facilitate improved and systematic PE across the medicines’ development lifecycle.

    • patient engagement
    • quality guidance
    • multi-stakeholder initiative
    • patient engagement medicines

    This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

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    • Contributors AMH, CP and NB identified participants, planned and organised multistakeholder working group workshops to co-create the PE Quality Guidance. KHOD, LD, OG, AMH, BNE, CP, DP, SES and NB participated in PE Quality Guidance co-creation workshops, tested and reviewed iterative drafts of the PE Quality Guidance; KHOD, SES, OG DR, LD, BNE, AMH, CP were part of the Core Team that reviewed and evaluated the example cases/projects for the Book of Good Practices; KHOD, LD, OG, AMH, BNE, CP, IS, DP, SES, NB jointly (and as part of a larger contributor group) reviewed the final versions of the PE Quality Guidance, scenarios and Book of Good Practices before release; KHOD, LD, OG, AMH, AH, BNE, CP, IS, DP, SES, NB jointly planned the manuscript and agreed the outline (with each author having responsibility for writing a specific section of the paper); IS coordinated writing efforts and developed each draft by collating and editing sections written by authors; circulated drafts for author review; collated and implemented author comments at each draft stage. KHOD, LD, OG, AMH, AH, BNE, CP, IS, DP, SES, NB reviewed and approved the final manuscript for submission.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests DR: personal fees from various pharmaceutical companies, outside the submitted work; NB: grants from various pharmaceutical companies and personal fees from Innovative Medicine Initiative outside the submitted work.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.