scholarly journals PHP14 - CO-CREATION OF PATIENT ENGAGEMENT QUALITY GUIDANCE AND QUALITY CRITERIA FOR MEDICINES DEVELOPMENT: AN INTERNATIONAL MULTI-STAKEHOLDER INITIATIVE

2018 ◽  
Vol 21 ◽  
pp. S153
Author(s):  
K. Deane ◽  
S.E. Skovlund ◽  
B. Nafria ◽  
L. Delbecque ◽  
O.V. Gorbenko ◽  
...  
Keyword(s):  
Patient Engagement ◽  
Quality Criteria ◽  
Multi Stakeholder

scholarly journals Evaluation of patient engagement in medicine development: A multi‐stakeholder framework with metrics

2021 ◽  
Vol 24 (2) ◽  
pp. 491-506
Author(s):  
Lidewij Eva Vat ◽  
Teresa Finlay ◽  
Paul Robinson ◽  
Giorgio Barbareschi ◽  
Mathieu Boudes ◽  
...  
Keyword(s):  
Patient Engagement ◽  
Medicine Development ◽  
Multi Stakeholder

scholarly journals Co-creation of patient engagement quality guidance for medicines development: an international multistakeholder initiative

2019 ◽  
Vol 5 (1) ◽  
pp. 43-55 ◽  
Author(s):  
Katherine Deane ◽  
Laure Delbecque ◽  
Oleksandr Gorbenko ◽  
Anne Marie Hamoir ◽  
Anton Hoos ◽  
...  
Keyword(s):  
Patient Engagement ◽  
Quality Criteria ◽  
User Feedback ◽  
Public Consultation ◽  
Good Practices ◽  
Comprehensive Guidance ◽  
Development Lifecycle ◽  
Diverse Backgrounds

IntroductionMeaningful patient engagement (PE) can enhance medicines’ development. However, the current PE landscape is fragmentary and lacking comprehensive guidance.MethodsWe 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).ResultsSeventy-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.DiscussionThe 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.

Workshop 5 (synthesis): water pollution abatement as related to ecosystem protection

2004 ◽  
Vol 49 (7) ◽  
pp. 165-168
Author(s):  
C. Hagebro ◽  
T. Chiuta ◽  
T. Belgrove
Keyword(s):  
Water Pollution ◽  
Pollution Abatement ◽  
Ecological Status ◽  
Quality Criteria ◽  
Protection Measures ◽  
Stakeholder Collaboration ◽  
Ecosystem Indicators ◽  
Multi Stakeholder ◽  
Good Ecological Status ◽  
The Eu

Water pollution exerts major stress on water systems and the challenge is to ensure security in river basins for both water-dependent activities and for the aquatic ecosystems. The workshop focused on protection of good ecological status, quality criteria, priorities for action, and on achievement of sustainable improvements. The three keynote speakers presented the concept applied in the EU Water Framework Directive, the need for a multi-stakeholder collaboration in order to reach a good ecological status of waters and a concrete example of interactive planning of water protection measures in a transboundary lake. The additional paper presentations addressed specific pollution problems in catchments, the effect of environmental user fees and ecosystem indicators.

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

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
David Feldman ◽  
Paola Kruger ◽  
Laure Delbecque ◽  
Ashley Duenas ◽  
Oana Bernard-Poenaru ◽  
...  
Keyword(s):  
Patient Engagement ◽  
Quality Criteria ◽  
English Summary ◽  
Public Consultation ◽  
Practical Implementation ◽  
Real Patient ◽  
Practical Applications ◽  
Stakeholder Groups ◽  
Patient Organizations ◽  
The Individual

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 guides have a standardized format and structure to promote user familiarity. They provide detailed guidance and examples that are relevant to the individual PE activity and aim to facilitate the practical implementation of PE. Conclusions The how-to guides form a comprehensive series of actionable and stepwise resources that build from and integrate the PE quality criteria across the medicines continuum. They will be made freely available through PFMD’s Patient Engagement Management Suite (pemsuite.org) and shared widely to a variety of audiences in different settings, ensuring access to diverse patient populations. Implementation of these guides should advance the field of PE in bringing new medicines to the market and ultimately will benefit patients. Plain English summary Medicines are developed to help patients improve their health and lives. Many organizations and individuals want to ensure that medicines are developed to meet real patient needs and to address what is most important to patients. Finding out what patients need and what patients want requires good patient engagement, but knowing how to do patient engagement is not always clear. This is because medicines development is complicated, and a lot of different steps, people, and organizations are involved. Patient Focused Medicines Development (PFMD) was established in 2015 to connect individuals and organizations that are committed to making medicines not just for patients but with patients. To do this, PFMD brought together patients and other groups of people with relevant experience and good ideas on how to achieve patient engagement in the real-world setting. Together, PFMD has developed “how-to guides” for patient engagement that cover the main activities along the medicines development process. The guides are free to use and provide practical advice and examples that anyone can use in their patient engagement activities. The how-to guides will also help patients to understand medicines development and how best they can participate in this process to address their needs.

scholarly journals The global impact of the International Federation of Clinical Chemistry and Laboratory Medicine, Education and Management Division: engaging stakeholders and assessing HbA1c quality in a multicentre study across China

2018 ◽  
Vol 57 (2) ◽  
pp. 288-295
Author(s):  
Emma English ◽  
Cas Weykamp ◽  
Linong Ji ◽  
Carla Siebelder ◽  
Zhongyan Shan ◽  
...  
Keyword(s):  
Multicentre Study ◽  
Clinical Chemistry ◽  
Quality Criteria ◽  
Policy Makers ◽  
Global Impact ◽  
Global Issue ◽  
Fresh Frozen ◽  
Allowable Error ◽  
Multi Stakeholder

Abstract Background Diabetes mellitus is a major global issue and high quality testing is essential for the diagnosis and treatment of the disease. The IFCC Committee for the Education in the Utility of Biomarkers in Diabetes (C-EUBD) plays a global role in improving knowledge and understanding around diabetes testing. This paper describes a multi-stakeholder approach, to improving diagnostic and therapeutic testing for diabetes, using a multicentre study in China as an example of the global impact of the group. Methods Educational workshops were developed to support the scientific aims of the study in which 30 centres around China received identical, fresh frozen whole blood samples with values assigned using IFCC secondary reference methods and undertook precision (EP-5) and trueness studies. Performance was assessed using sigma metrics. Results A successful multi-stakeholder group was developed and sustained throughout the study through several educational workshops, which enabled the formation of a long-term collaboration with key opinion leaders and policy makers in China. All 30 centres showed good performance with within and between laboratory coefficient of variations (CVs) below 3% in SI units at both low and high haemoglobin A1c (HbA1c) levels. All individual laboratories met the criteria of a sigma of two or more at a total allowable error (TAE) of 5 mmol/mol (0.46% NGSP). Conclusions The study led to a successful multi-partner approach to improving diabetes testing in China. All centres involved in the study meeting the published IFCC quality criteria, paving the way for future clinical trials and an expanded role for HbA1c testing across the country.

scholarly journals PNS249 WHAT ARE THE PRIORITY PATIENT ENGAGEMENT ACTIVITIES IN MEDICINES DEVELOPMENT? RESULTS OF A GLOBAL MULTI-STAKEHOLDER CONSULTATION

2019 ◽  
Vol 22 ◽  
pp. S328
Author(s):  
S. Skovlund ◽  
O.V. Gorbenko ◽  
D.P. Richards ◽  
B. Nafria ◽  
L. Delbecque ◽  
...  
Keyword(s):  
Patient Engagement ◽  
Stakeholder Consultation ◽  
Multi Stakeholder

scholarly journals Bratislava Statement: consensus recommendations for improving pancreatic cancer care

ESMO Open ◽  
2020 ◽  
Vol 5 (6) ◽  
pp. e001051
Author(s):  
Joan Prades ◽  
Dirk Arnold ◽  
Thomas Brunner ◽  
Antonella Cardone ◽  
Alfredo Carrato ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Cancer Care ◽  
Quality Care ◽  
Quality Criteria ◽  
Health Impact ◽  
Multidisciplinary Teams ◽  
Consensus Recommendations ◽  
Specific Care ◽  
Multi Stakeholder ◽  
The Impact

Pancreatic cancer is one of the most lethal tumours, and it is the fourth cause of cancer death in Europe. Despite its important public health impact, no effective treatments exist, nor are there high-visibility research efforts to improve care. This alarming situation is emblematic of a larger group of cancer diseases, known as neglected cancers. To address the impact of these diseases, the European Commission-supported Innovative Partnership for Action Against Cancer launched a multi-stakeholder initiative to determine key steps that healthcare systems can rapidly implement to improve their response. A working group comprising 20 representatives from European medical societies, patient associations, cancer plan organisations and other relevant European healthcare stakeholders was organised. A consensus process based on the results of different studies, discussion of research outcomes, and development and endorsement of draft statements resulted in 22 consensus recommendations (the Bratislava Statement). The statement argues that substantial improvements can be achieved in patient outcomes by centralising pancreatic cancer care around state-of-the-art reference centres, staffed by expert multidisciplinary teams capable of providing high-quality care. This organisational model requires a specific care framework encompassing primary, palliative and survivorship care, and a policy environment prioritising the use of quality criteria and performance assessments as well as research investments dedicated to prevention, risk prediction, early detection and diagnosis. In order to address the challenges posed by neglected cancers in general and pancreatic cancer in particular, a specific control strategy tailored to this reality is required.

scholarly journals Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action

2021 ◽  
Author(s):  
Maria Cavaller-Bellaubi ◽  
Stuart D. Faulkner ◽  
Bryan Teixeira ◽  
Mathieu Boudes ◽  
Eva Molero ◽  
...  
Keyword(s):  
Patient Engagement ◽  
Success Factors ◽  
Theory Of Change ◽  
Systematic Change ◽  
Policy Makers ◽  
Patient Organisations ◽  
Strategic Goals ◽  
Multi Stakeholder ◽  
Consultative Body ◽  
Change Concept

Abstract Background There is increased recognition that incorporating patients’ perspectives and insights into the medicines development process results in better health outcomes and benefits for all involved stakeholders. Despite the increased interest and the existence of frameworks and practical recommendations, patient engagement (PE) is not yet considered standard practice. The objective of this work was to provide a roadmap to support systematic change in all stakeholder organisations involved in medicines development across Europe, patients and patient organisations, medicines developers, academia, regulatory authorities, Health Technology Assessment bodies, payers, policy-makers and public research funders, to sustain PE practices. Methods A mixed-methods approach was used by the EU-funded Innovative Medicines Initiative PARADIGM Consortium to co-develop the sustainability roadmap including background work to identify success factors and scenarios for sustainable PE. The roadmap development was based on the Theory of Change concept and populated with findings from (1) interviews with national/ and international institutions with the potential to increase PE uptake by other stakeholders; (2) multi-stakeholder workshops and webinars; and (3) consultations with specific stakeholder groups, Consortium members and a consultative body formed by international PE initiatives. Results This roadmap sets strategic goals for the PE community to achieve meaningful and systematic PE through changes in the culture, processes and resources of stakeholder organisations. It brings in key PARADIGM outputs to work in a coordinated fashion with existing frameworks and mechanisms to achieve system-wide sustained PE. Conclusions The roadmap provides a framework for all stakeholders to take collective action within their organisations and across Europe to implement PE in a sustainable manner.

scholarly journals Optimising Multi-stakeholder Practices in Patient Engagement: A Gap Analysis to Enable Focused Evolution of Patient Engagement in the Development and Lifecycle Management of Medicines

2021 ◽  
Author(s):  
S. D. Faulkner ◽  
C. A. C. M. Pittens ◽  
N. S. Goedhart ◽  
E. H. Davies ◽  
E. Manning ◽  
...  
Keyword(s):  
Patient Engagement ◽  
Gap Analysis ◽  
Contextual Information ◽  
Large Set ◽  
Training Material ◽  
Global Databases ◽  
Roles And Responsibilities ◽  
Multi Stakeholder ◽  
Context Element ◽  
Lifecycle Management

Abstract Background The PARADIGM consortium aimed to make patient engagement in the development and lifecycle management of medicines easier and more effective for all, with the development of new tools that fulfil robustly defined gaps where engagement is suboptimal. Aims To generate an inventory of gaps in patient engagement practices and process from existing global examples. Methods A large set of criteria for effective patient engagement previously defined via a multi-stakeholder Delphi method, were mapped under fourteen overarching themes. A gap analysis was then performed by twenty-seven reviewers against the resulting forty-six mapped criteria, on a sample of seventy initiatives from global databases. Results An inventory of gaps was identified including contextual information as to why the gaps exist. Our work identified general patterns where patient engagement was suboptimal—defined as; fragmented reporting and dissemination of patient engagement activities, and the fundamental principles defined in frameworks or guidance being poorly adhered to in actual practice. Specific gaps were identified for sixteen criteria. Additionally, it was also common to observe primary aspects of a process were addressed for a given criteria (i.e. training for roles and responsibilities) but a secondary context element was lacking (i.e. making training material accessible/understandable/meaningful to all participants). Conclusion The results show that the evolution towards meaningful and systematic patient engagement is occurring, yet more importantly they provide clear directional insights to help enhance collaborative practices and co-design solutions. This targeted impact to catalyse a needs-oriented health system that integrates patient engagement at its core is essential.

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