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.

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.

VP165 Landscape Assessment: Patient Engagement In Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 224-225
Author(s):  
Elisabeth Oehrlein ◽  
Jason Harris ◽  
Nicole Labkoff ◽  
Eleanor Perfetto ◽  
Manal Ziadeh ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Patient Engagement ◽  
Public Involvement ◽  
Web Search ◽  
Health Technology ◽  
Public Consultation ◽  
Patient Questionnaire ◽  
Draft Guidance ◽  
Stakeholder Consultation

INTRODUCTION:Understanding the current landscape of patient engagement across value decision-making bodies internationally is a critical first step toward improving the patient centricity of Health Technology Assessment (HTA). This study assessed: (i) Terms and definitions used; (ii) Patient engagement opportunities; (iii) Evidence of patient engagement.METHODS:A sample of country-specific HTA's (HTA; n = 6), professional organizations (PO; n = 4), and collaborations/independent organizations (CO; n = 3) was selected for representativeness. Information was gathered through: (i) targeted web search and (ii) emailing organizations directly. Definitions, HTA methods documents, and the three most recent evaluations were identified, abstracted, and compared. Data were collected between September-October 2016.RESULTS:Numerous terms are used to describe patient engagement: patient input (HTA = 1, PO = 1), patient-group submitted information (HTA = 1), cooperation with patients/users (HTA = 1), public consultation (HTA = 1), patient perspectives (HTA = 1, PO = 1), involvement of people affected (HTA = 1), patient involvement (HTA = 2), patient and public involvement (HTA = 1), lay involvement (HTA = 1), inclusion of patient representative (PO = 3), patient reports (PO = 1), patient preference (PO = 2), public consultation (CO = 1), stakeholder consultation (CO = 1), open input (CO = 1), stakeholder engagement (CO = 1), and patient participation (CO = 1). Opportunities for patient engagement were described as: patient questionnaire (HTA = 2); comment period (HTA = 1; CO = 1); committee participation (HTA = 3; PO = 3); propose topics (HTA = 1); draft guidance (HTA = 1); general stakeholder forum (CO = 1). While organizations outline opportunities for patient engagement, not all organizations have clear evidence the practices are used or have impact. Recent evaluations demonstrate clear evidence of engagement (HTA = 2); Unclear or mixed evidence (HTA = 1; PO = 1; CO = 2); No evidence (HTA = 3; PO = 3; CO = 1).CONCLUSIONS:There is substantial heterogeneity in the terms used to describe patient engagement activities across organizations. While a variety of opportunities for patient engagement are described, lack of clear evidence to how patient engagement practices are consistently used may contribute to the perception that engagement by HTAs.

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

Code of Good Practices on Fiscal Transparency, revised April 2007

Policy Papers ◽  
2007 ◽  
Vol 2007 (15) ◽  
Author(s):  
Keyword(s):  
Public Consultation ◽  
Consultation Process ◽  
Good Practices ◽  
Roles And Responsibilities ◽  
Fiscal Transparency ◽  
Public Availability ◽  
The Imf

The IMF has revised its Code of Good Practices on Fiscal Transparency, following a public consultation process. Nine new practices have been added to the Code and many existing practices have been broadened in scope. The four pillars of the original Code remain unchanged: clarity of roles and responsibilities, open budget processes, public availability of information and assurances of integrity. The revised Code will be used in IMF surveillance and in voluntary assessments of fiscal transparency in member countries under the standards and codes initiative. Two associated documents - the Manual on Fiscal Transparency (2007) and the Guide on Resource Revenue Transparency (2007) - provide supporting in-depth coverage of good practices.

scholarly journals Adecuación de la Norma ISO/IEC 29110 e IEEE 829 para la gestión de proyectos de desarrollo con metodología Iconix.

2020 ◽  
Vol 12 (24) ◽  
pp. 6-15
Author(s):  
Beatriz Eugenia Marín Ospina
Keyword(s):  
Quality Criteria ◽  
Good Practices ◽  
Software Products ◽  
Long Time ◽  
The Subject ◽  
Minimum Quality ◽  
Buenas Prácticas

Los productos de software deben garantizar el cumplimiento de criterios mínimos de calidad aplicando métodos y buenas prácticas propuestas a partir de las experiencias de autores y organizaciones que han trabajado en el tema por mucho tiempo. Estas experiencias brindan lineamientos que se pueden ajustar a diversos contextos. En este proyecto se presenta la adecuación de las prácticas propuestas por la norma ISO/IEC 29110 para gestión de proyectos de desarrollo en pequeñas empresas, integrando la metodología Iconix para guiar los procesos de desarrollo de software y la IEEE 829 para documentar las pruebas en el marco del desarrollo del módulo de transferencia y comunicación de datos de las estaciones ambientales de la empresa San Ambiente de Cali. Este trabajo corresponde a la fase 1 del macroproyecto “Desarrollo de un aplicativo de gestión de datos ambientales para la empresa San Ambiente de Cali”, perteneciente al semillero ITMedia de la Facultad de Ingenierías de la Institución Universitaria Antonio José Camacho. Software products must ensure compliance with minimum quality criteria by applying methods and good practices that have been proposed based on the experiences of authors and organizations that have worked on the subject for a long time. These experiences provide guidelines that can be adjusted to different contexts.

Architecture-Driven Service Discovery for Service Centric Systems

2011 ◽  
pp. 811-842 ◽  
Author(s):  
A. Kozlenkov ◽  
G. Spanoudakis ◽  
A. Zisman ◽  
V. Fasoulas ◽  
F. Sanchez
Keyword(s):  
Service Discovery ◽  
Graph Matching ◽  
Quality Criteria ◽  
Software Systems ◽  
Design Phase ◽  
Design Models ◽  
Prototype Tool ◽  
Development Lifecycle ◽  
Execution Engine ◽  
Matching Techniques

Service discovery has been recognized as an important aspect in the development of service-centric systems, i.e., software systems which deploy Web services. To develop such systems, it is necessary to identify services that can be combined in order to fulfill the functionality and achieve quality criteria of the system being developed. In this paper, we present a framework supporting architecture-driven service discovery (ASD)—that is the discovery of services that can provide functionalities and satisfy properties and constraints of systems as specified during the design phase of the development lifecycle based on detailed system design models. Our framework assumes an iterative design process and allows for the (re-)formulation of design models of service-centric systems based on the discovered services. The framework is composed of a query extractor, which derives queries from behavioral and structural UML design models of service-centric systems, and a query execution engine that executes these queries against service registries based on graph matching techniques. The article describes a prototype tool that we have developed to demonstrate and evaluate our framework and the results of a set of preliminary experiments that we have conducted to evaluate it.

scholarly journals PP037 Quality Criteria And Good Practices In The Health Technology Assessment Spanish Network

2017 ◽  
Vol 33 (S1) ◽  
pp. 86-87
Author(s):  
Sergio Márquez-Peláez ◽  
Carmen Navarro-Palenzuela ◽  
Teresa Molina-Lopez ◽  
María del Mar Castellano-Zurera ◽  
José Luis Castro-Campos
Keyword(s):  
Quality Management ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Management System ◽  
Quality Management System ◽  
Quality Criteria ◽  
Quality Standards ◽  
Health Technology ◽  
Good Practices ◽  
Quality Aspects

INTRODUCTION:The Spanish Network of Agencies for Health Technology Assessment (REDETS) is a group of eight agencies, units and services, depending on National and Regional Governments that coordinate their work within a common methodological framework, guided by the principles of mutual recognition and cooperation. In this work, guided by the necessity of implementing a Quality Management System, we present the process to achieve this objective.METHODS:As an initial step, a review was carried out based on a structured search strategy in the main electronic databases Medline and EMBASE, and a manual search in websites of national and international agencies (March 2016) in order to collate previous knowledge and experiences. Through the information included in this review, a proposal to create a quality, self-evaluating tool is necessary.RESULTS:In total, 800 references were found and finally 6 studies were included in the review (1-3). All had a similar structure. Some lists of good practices, classified in dimensions related to different quality aspects in Health Technology Assessment (HTA) organizations, were found. Also some information about questions for evaluating quality standards was indicated. Taking all this information, a proposal of sixty-six standard titles was put forward. These standards were then grouped into twelve quality criteria structured in four dimensions: I Responsibility, II Clients and Stakeholders, III Production Process and IV Resources.CONCLUSIONS:Based on the systematic review, we developed a proposal for a self-evaluating tool and this is the baseline for a common Quality Management System for the Spanish Network of HTA Agencies. The quality management process will require the development of a handbook by each member of REDETS that will be based on agreed quality standards.

A Decade of Veteran Voices: Examining Patient Portal Enhancements Through the Lens of User-Centered Design (Preprint)

2018 ◽  
Author(s):  
Kim M Nazi ◽  
Carolyn L Turvey ◽  
Dawn M Klein ◽  
Timothy P Hogan
Keyword(s):  
Health Care ◽  
Patient Engagement ◽  
User Feedback ◽  
Fiscal Year ◽  
Patient Portal ◽  
User Centered Design ◽  
User Characteristics ◽  
Web Based ◽  
User Centered

BACKGROUND Health care systems have entered a new era focused on patient engagement. Patient portals linked to electronic health records are recognized as a promising multifaceted tool to help achieve patient engagement goals. Achieving significant growth in adoption and use requires agile evaluation methods to complement periodic formal research efforts. OBJECTIVE This paper describes one of the implementation strategies that the Department of Veterans Affairs (VA) has used to foster the adoption and sustained use of its patient portal, My HealtheVet, over the last decade: an ongoing focus on user-centered design (UCD). This strategy entails understanding the users and their tasks and goals and optimizing portal design and functionality accordingly. Using a case study approach, we present a comparison of early user demographics and preferences with more recent data and several examples to illustrate how a UCD can serve as an effective implementation strategy for a patient portal within a large integrated health care system. METHODS VA has employed a customer experience analytics (CXA) survey on its patient portal since 2007 to enable ongoing direct user feedback. In a continuous cycle, a random sample of site visitors is invited to participate in the Web-based survey. CXA model questions are used to track and trend satisfaction, while custom questions collect data about users’ characteristics, needs, and preferences. In this case study, we performed analyses of descriptive statistics comparing user characteristics and preferences from FY2008 (wherein “FY” means “fiscal year”) to FY2017 and user trends regarding satisfaction with and utilization of specific portal functions over the last decade, as well as qualitative content analysis of user’s open-ended survey comments. RESULTS User feedback has guided the development of enhancements to core components of the My HealtheVet portal including available features, content, interface design, prospective functional design, and related policies. Ten-year data regarding user characteristics and portal utilization demonstrate trends toward greater patient engagement and satisfaction. Administration of a continuous voluntary Web-based survey is an efficient and effective way to capture veterans’ voices about who they are, how they use the patient portal, needed system improvements, and desired additional services. CONCLUSIONS Leveraging “voice-of-the-customer” techniques as part of patient portal implementation can ensure that such systems meet users’ needs in ways that are agile and most effective. Through this strategy, VA has fostered significant adoption and use of My HealtheVet to engage patients in managing their health.

Youth Inclusion and Cultural Diversity

2020 ◽  
pp. 217-232
Author(s):  
Jordi Pàmies ◽  
Alessio D’Angelo
Keyword(s):  
At Risk ◽  
Young People ◽  
Cultural Diversity ◽  
Social Cohesion ◽  
European Level ◽  
Good Practices ◽  
Social Pedagogy ◽  
Diverse Backgrounds ◽  
Policy Frameworks ◽  
Selection Of

This chapter discusses a range of theoretical and practical issues concerning processes of inclusion of young people from “culturally diverse” backgrounds. It first presents some of the main available indicators of young people’s exclusion and reviews policy frameworks and interventions at the European level. Next, it problematizes the current conceptualization of youth inclusion, highlighting the importance of adopting an intersectional perspective and arguing that any meaningful approach to inclusion must be accompanied by the promotion of social cohesion and anti-discrimination. On this basis, the chapter discusses how social pedagogy can be used to celebrate cultural diversity, enhancing the opportunities of those otherwise at risk of marginalization, promoting their empowerment, and combating deficit models. Finally, the chapter presents an overall framework to identify good practices of inclusion, which informed the selection of a range of experiences and practices on the ground throughout Europe.

Health Communication: Implications for Diverse Populations

2011 ◽  
Vol 18 (1) ◽  
pp. 12-19
Author(s):  
Amy Hasselkus
Keyword(s):  
Health Care ◽  
Health Communication ◽  
Negative Impact ◽  
Linguistically Diverse ◽  
Good Health ◽  
The United States ◽  
Poor Health ◽  
Health Care Decisions ◽  
Diverse Backgrounds ◽  
Health Related

The need for improved communication about health-related topics is evident in statistics about the health literacy of adults living in the United States. The negative impact of poor health communication is huge, resulting in poor health outcomes, health disparities, and high health care costs. The importance of good health communication is relevant to all patient populations, including those from culturally and linguistically diverse backgrounds. Efforts are underway at all levels, from individual professionals to the federal government, to improve the information patients receive so that they can make appropriate health care decisions. This article describes these efforts and discusses how speech-language pathologists and audiologists may be impacted.

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