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Co-creation of practical “how-to guides” for patient engagement in key phases of medicines development—from theory to implementation

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Názov: Co-creation of practical “how-to guides” for patient engagement in key phases of medicines development—from theory to implementation
Autori: Feldman, David, Kruger, Paola, Delbecque, Laure, Duenas, Ashley, Bernard-Poenaru, Oana, Wollenschneider, Séverine, Hicks, Nick, Reed, Janine Ann, Sargeant, Ify, Pakarinen, Chi, Hamoir, Anne-Marie, Deane, Katherine, Fox, Grace, Oleksandr, Gorbenko, Hartke, Jim, Larsen, Vivian, Missbach, Benjamin, Nolan, Claire, Ratcliffe, Natasha, Scrafton, Carole, Williams, Merlin, Kaschinski, Dagmar, Hamerlijnck, Dominique, Goins, Janelle, Peterson, Janet, Scott, Jessica, Bassi, Adit, Gillen, Angi, Sunwold, Duane, Ryan, Jeanette, Preston, Jennifer, Garcia, Marta, Zvonareva, Olga, Camp, Rob, Grootens, Ronella, Wollenschneider, Severine, Escudier, Thierry
Informácie o vydavateľovi: Springer Science and Business Media LLC
Rok vydania: 2021
Zbierka: The University of Liverpool Repository
Popis: Abstract Background The effective impact of patient engagement (PE) across the medicines development continuum is widely acknowledged across diverse health stakeholder groups, including health authorities; however, the practical applications of how to implement meaningful and consistent PE are not always addressed. Guidance for the practical implementation of PE requires granularity, and the need for such guidance has been identified as a priority. We describe the co-production and summarize the content of how-to guides that focus on PE in the early stages of medicines development. Methods Multi-stakeholder working groups (WGs) were established by Patient Focused Medicines Development (PFMD) for how-to guide development. How-to guides were co-produced with patients for PE activities identified as priorities through public consultation and by WGs. Guides were developed by applying PE quality guidance and associated quality criteria in an iterative process. How-to guides underwent internal review and validation by experts (ie, those with relevant experience in the particular PE activity or focus area) in specific focus groups and external review and validation through appropriate events and public consultation. Results Overall, 103 individual contributors from 38 organizations (representing eight stakeholder groups, including patients/patient organizations) and from 14 countries were organized into WGs and workstreams. Each WG comprised 15–30 contributors with PE experience relevant to the specific how-to guide. How-to guides were developed for PE in the early discovery and preclinical phases; PE in the development of a clinical outcomes assessment strategy; and PE in clinical trial protocol design. The how-to ...
Druh dokumentu: article in journal/newspaper
Jazyk: English
Relation: Collapse authors list. Feldman, David, Kruger, Paola, Delbecque, Laure, Duenas, Ashley, Bernard-Poenaru, Oana, Wollenschneider, Séverine, Hicks, Nick, Reed, Janine Ann, Sargeant, Ify, Pakarinen, Chi et al (show 34 more authors) , Hamoir, Anne-Marie, Bernard-Poenaru, Oana, Deane, Katherine, Feldman, David, Fox, Grace, Oleksandr, Gorbenko, Hartke, Jim, Hicks, Nick, Larsen, Vivian, Missbach, Benjamin, Nolan, Claire, Ratcliffe, Natasha, Scrafton, Carole, Williams, Merlin, Duenas, Ashley, Kaschinski, Dagmar, Hamerlijnck, Dominique, Goins, Janelle, Peterson, Janet, Scott, Jessica, Delbecque, Laure, Kruger, Paola, Bassi, Adit, Gillen, Angi, Sunwold, Duane, Reed, Janine Ann, Ryan, Jeanette, Preston, Jennifer orcid:0000-0003-4800-234X , Garcia, Marta, Zvonareva, Olga, Camp, Rob, Grootens, Ronella, Wollenschneider, Severine and Escudier, Thierry (2021) Co-creation of practical “how-to guides” for patient engagement in key phases of medicines development—from theory to implementation. Research Involvement and Engagement, 7 (1). 57-. ISSN 2056-7529, 2056-7529
DOI: 10.1186/s40900-021-00294-x
Dostupnosť: https://livrepository.liverpool.ac.uk/3144855/
https://doi.org/10.1186/s40900-021-00294-x
Prístupové číslo: edsbas.EF08033B
Databáza: BASE
Popis
Abstrakt:<jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>The effective impact of patient engagement (PE) across the medicines development continuum is widely acknowledged across diverse health stakeholder groups, including health authorities; however, the practical applications of how to implement meaningful and consistent PE are not always addressed. Guidance for the practical implementation of PE requires granularity, and the need for such guidance has been identified as a priority. We describe the co-production and summarize the content of how-to guides that focus on PE in the early stages of medicines development.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>Multi-stakeholder working groups (WGs) were established by Patient Focused Medicines Development (PFMD) for how-to guide development. How-to guides were co-produced with patients for PE activities identified as priorities through public consultation and by WGs. Guides were developed by applying PE quality guidance and associated quality criteria in an iterative process. How-to guides underwent internal review and validation by experts (ie, those with relevant experience in the particular PE activity or focus area) in specific focus groups and external review and validation through appropriate events and public consultation.</jats:p> </jats:sec><jats:sec> <jats:title>Results</jats:title> <jats:p>Overall, 103 individual contributors from 38 organizations (representing eight stakeholder groups, including patients/patient organizations) and from 14 countries were organized into WGs and workstreams. Each WG comprised 15–30 contributors with PE experience relevant to the specific how-to guide. How-to guides were developed for PE in the early discovery and preclinical phases; PE in the development of a clinical outcomes assessment strategy; and PE in clinical trial protocol design. The how-to ...
DOI:10.1186/s40900-021-00294-x