Patient & Citizen Involvement

To support good practice, PCIG develops resources based on published literature and consultation with our members and stakeholders. Here you’ll find our resources to support patient participation and patient-based evidence. There’s also a tab for of our partners and friends and our which contains older resources that are less often used or not updated.

GETTING STARTED:
HTA and patient involvement presentation: Slides
HTAi Values and Quality Standards for Patient and Citizen Involvement in HTA:

• Poster (English)
• PDF (English)
• PDF (French)

HTA terms in plain language.
English | Greek

PATIENT PARTICIPATION:
Plain language summaries of applications to HTA bodies for patient groups:

• Template | Overview
• Guidance for industry | HTA bodies | Patient groups

Written submission templates for adaptation (word docs)

• Medicines HTA
  • English
  • French
  • Spanish
  • Cover Note
• Non-medicines HTA
  • English
  • French
  • Spanish – modified
  • Cover Note
• Diagnostics HTA
  • English
  • Spanish – modified version
  • Guide
  • Info for Patients
  • Cover Note for Agencies
• Re-appraisal of rare disease treatment
  • IMPACT HTA

Guidance for patient groups collecting and reporting information for input:
PDF | Word.
Ethics for patient group collecting and reporting information for HTA input
Short (2 pages) | Long (7 pages)
Engaging patients in Early Dialogue: Tools and resources for HTA bodies (PCIG for IMI PARADIGM)
Patient and Citizen Involvement Resource Directory: Collection of government and organization resources to assist patient and citizen involvement in HTA

PATIENT BASED EVIDENCE
Conducting primary and secondary research to determine patients’ perspectives – Guides from other HTA Agencies: Denmark | Scotland | Sweden
Rapid Qualitative Evidence Synthesis: Methodology | Coding Template | Guide

IMPACT
Perspectives of impact: share your experience of a time when patient involvement had an impact in HTA
Impact template

OTHER USEFUL RESOURCES
INAHTA Position Statement on Patient Involvement in HTA (the who, what, when, how and why)
Guidelines International National Public Toolkit: Patient and public involvement in guidelines. Including consultation, participation, communication and a chapter on HTA tools
Patient Involvement in HTA in Europe: A 360° Review of Stakeholder Experiences with Patient Involvement in HTA in Europe
Health Equality Europe: A Guide to Understanding HTA for Patients and the Public: English | Spanish | Mandarin | Italian | Polish | Greek
The European Patients’ Academy (EUPATI) – Short guides and videos about HTA (Weblink) Patient Expert Training Course, including module on HTA
CADTH pan-Canadian Oncology Drug Review (pCODR) Guide for Patient Advocacy Groups (PDF) to provide submissions for oncology drugs undergoing HTA review
Scottish Health Council (SHC) Participation Toolkit: How to Conduct Surveys
Scottish Medicines Consortium (SMC) Review of Patient Involvement

ARCHIVES
Granados A, Mullin T, Moseley J, Meyer F, Avetisyan R, Wong-Rieger D, Kaatee M, Skinner M, Leyden S.
Multistakeholder Approaches to Improve Evidence-Based Decisions in Rare Diseases: Engagement of Patients and Patient Organizations. Report of HTAi 2016 Panel Session. Health Technology Assessment International – Canada. 2016
HTAi PCIG (Feb 2015) Good Practice Examples of Patient and Public Involvement in Health Technology Assessment.
FAQs could be one document for all three.
Citizen and Patient Involvement Library: HTAi Vortal – A searchable collection of peer reviewed papers on patient and public involvement in HTA. This resource was developed in collaboration with the Information Retrieval IG.

RELEVANCE
Patients have knowledge, perspectives and experiences that are unique and contribute to essential evidence for HTA.

FAIRNESS
Patients have the same rights to contribute to the HTA process as other stakeholders and have access to processes that enable effective engagement.

EQUITY
Patient involvement in HTA contributes to equity by seeking to understand the diverse needs of patients with a particular health issue, balanced against the requirements of a health system that seeks to distribute resources fairly among all users.

LEGITIMACY
Patient involvement facilitates those affected by the HTA recommendations/decision to participate in the HTA; contributing to the transparency, accountability and credibility of the decision-making process.

CAPACITY BUILDING
Patient involvement processes address barriers to involving patients in HTA and build capacity for patients and HTA organizations to work together.

QUALITY STANDARDS FOR PATIENT INVOLVEMENT IN HTA
GENERAL HTA PROCESS
1. HTA organizations have a strategy that outlines the processes and responsibilities for those working in HTA and serving on HTA committees to effectively involve patients.
2. HTA organizations designate appropriate resources to ensure and support effective patient involvement in HTA.
3. HTA participants (including researchers, staff, HTA reviewers and committee members) receive training about appropriate involvement of patients and consideration of patients’ perspectives throughout the HTA process.
4. Patients and patient organizations are given the opportunity to participate in training to empower them so that they can best contribute to HTA.
5. Patient involvement processes in HTA are regularly reflected on and reviewed, taking account of the experiences of all those involved, with the intent to continuously improve them.

FOR INDIVIDUAL HTAS
1. Proactive communication strategies are used to effectively reach, inform and enable a wide range of patients to participate fully in each HTA.
2. Clear timelines are established for each HTA with advance notice of deadlines to ensure that appropriate input from a wide range of patients can be obtained.
3. For each HTA, HTA organizations identify a staff member whose role is to support patients to contribute effectively to HTA.
4. In each HTA, patients’ perspectives and experiences are documented and the influence of patient contributions on conclusions and decisions is reported.
5. Feedback is given to patient organizations who have contributed to an HTA, to share what contributions were most helpful and provide suggestions to assist their future involvement.

Supported by an unrestricted grant from Eli Lilly (June 2014)
Also available as a poster or two-page PDF in English and French.

WHAT CAN YOU DO TO SUPPORT THESE VALUES AND STANDARDS?
Endorse them Nominate an organization for ‘excellent effort’ to attain them

CONTACT US TO GET INVOLVED
Twitter @pcisg
Email pat.standards@btinternet.comht

The International Alliance of Patient Organizations (IAPO)
IAPO is a global alliance representing patients of many different nationalities across disease areas and promotes patient-centered healthcare around the world.

Guideline International Network (GIN) Patient and Public Involvement Working Group
GIN PUBLIC Toolkit about Patient and Public Involvement in Guidelines: experiences of the organizations involved in guideline development.

INAHTA
INAHTA is a network that connects HTA agencies to each other to support knowledge sharing and the exchange of information, and also to serve as a forum for the identification and promotion of other interests of HTA agencies. INAHTA Survey on the Involvement of Patients in HTA Activities Download survey report This report compares survey data from 2005 and 2010 of INAHTA members. The objective was to obtain information on what INAHTA member organizations did and what they avoided in involving consumers in the HTA process.

World Health Organization (WHO): Universal health coverage

European Patients’ Forum
European Patients’ Forum: Patient Involvement in HTA in Europe – an interim report on EPF’s survey with HTA agencies.
The European Patients Forum (EPF) completed three phases of research to understand the involvement of lay patients, informal careers and patient organizations EU member states HTA and decision making processes. The reports cover three areas of patient involvement:
* HTA agencies
* HTA appraisal committees and decision makers
* Patient organizations

European Academy of Patients (EUPATI)
The European Academy of Patients is an initiative of IMI (Innovative Medicines Initiative) whose goal is to offer patients and their families opportunities for training in research and development of medicines and therapies, with an emphasis on scientifically valid information. Launched in 2012 with joint funding from the European Community and EFPIA (European Federation of Pharmaceutical Industries and Associations), it involves a consortium of 30 organizations and extends, for the moment, throughout 12 countries of the European Community.

EUnetHTA
To create an effective and sustainable network for HTA across Europe – by working together to help developing reliable, timely, transparent and transferable information to contribute to HTAs in European countries.

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
Promotes the science of pharmacoeconomics (health economics) and outcomes research (the scientific discipline that evaluates the effect of health care interventions on patient well-being including clinical, economic, and patient-centered outcomes) and facilitates the translation of this research into useful information for health care decision makers to increase the efficiency, effectiveness, and fairness of health care to improve health.

Patients Active in Research and Dialogues for an Improved Generation of Medicines (PARADIGM)
This is a public-private partnership, co-led by the European Patients’ Forum and EFPIA, to advance meaningful patient engagement in the life cycle of medicines for better health outcomes. The PCIG is a member of this partnership.

Patient Focused Medicines Development (PFMD)
PFMD aims to transform the way in which we understand, engage, and partner with patients globally in the design and development of research and medicines by focusing on unmet patient needs. It brings together and synergizes disparate but complementary efforts that integrate the voice of the PATIENT across the lifecycle of medicine.

Project #001
Aim: Better understanding of patient participation in organizational domain; identifying how/what topics dialogue between patients/patient groups/citizens & HTA bodies is occurring, what facilitates it.

Leads: Hervé Nabarette (AFM-Téléthon, France)

Team Members: PCIG: Ann Single (Patient Voice Initiative, Australia), Isabelle Ganache (INESSS, Quebec), Jean-Claude K Dupont (APHP hospital, France)

• Project Description
  • Project Proposal
• Current Status Reports
  • January 2022 Update
  • March 2022 Update
• Other Material
  • NIL

Project #002
Aim: Aid reflection on the impact and mechanisms of patient and citizen involvement in HTA by trialing the use of a template to capture different stakeholders’ perspectives and stories.

Leads: Aline Silveira Silva (Researcher/Patient Voices Network, Brazil/Canada) & Veronica Lopez Gousset (VLG Consulting, France)

Team Members: Ann Single (Patient Voice Initiative, Australia), Anke Peggy Holtorf (Consultant, Switzerland), Marcus Simon (Shockwave Medical, Belgium), Ana Toledo Chavarri (SESCS, Spain), Valentina Strammiello (European Patients’ Forum, Europe), Elitsa Ivanova (Servier, Pharma)

• Project Description
  • Project Proposal
• Current Status Reports
  • January 2022 Update
  • March 2022 Update
• Other Material
  • Project Summary Presentation
  • Open Access Paper: Holtorf, A., Mueller, D., Sousa, M., Pretorius, L., Wijaya, K., Adeyemi, S., & Ankleshwaria, D. (2021). Pilot approach to analyzing patient and citizen involvement in health technology assessment in four diverse low- and middle-income countries. International Journal of Technology Assessment in Health Care, 37(1), E1. doi:10.1017/S0266462320002263

Project #011
Aim: To collaborate with key stakeholders to provide HTAs with actionable resources to increase implementation and adoption of patient preferences in decision-making.

Leads: Simon Fifer (CaPPRe, Australia) & Barry Liden (Edwards Lifesciences, USA))

Team Members: Eric Low (Eric Low Consulting, UK), Deborah Marshall (University of Calgary, Canada), Adrian Skelly (Novartis, Ireland), Barry Stein (Colorectal Cancer Canada), Alissa Hanna (Edwards Lifesciences, USA)

Further Information:

• Project Proposal
  • Project Description
• Current Status Report
  • 011 November Update
  • March 2022 Update
  • Case study planning commenced
• Other Interim Material
  • HTA Surveys and Analysis
  • ‘Do Patients Preferences Influence HTA Decisions‘ – webinar broadcast on Nov 18, 2021
  • 4-Part Webinar Series
  • See PAST PROJECTS for Patient Preferences project #008

Aim: A whitepaper detailing pre-requisites & stakeholder expectations of a structured, observatory platform to collect & analyse social media content to inform HTA bodies of patient needs & experiences. Leads: Anke-Peggy Holtorf & Andrii Danyliv (Novartis).

Team Members: Jennifer Dickson/Lindsey Lockhart (SMC, Scotland), Jane Tsai (Formosa Cancer Foundation, Taiwan) Alissa Hanna (Edwards Life Sciences, USA), Li-Ying Huang (CDE/HTA, Taiwan), Annekatrin Krause (Patient Advocacy Novartis, Switzerland), Joey Mattingly (University of Maryland, USA), Yvette Venable (ICER, USA), Donna Walsh (EFNA).

Further information:

• Project Description
  • Project Proposal
• Current Status Report
  • January 2022 Update
  • March 2022 Update
• Other Material
  • PIRP Summary
  • PCIG-Bulletin

Project #011

Aim: Encourage implementation & adoption of template worldwide by raising awareness & developing training & communication resources, pilots & by obtaining stakeholder feedback

Leads: Martin Coombes (BMS) & Kate Morgan (Myeloma Europe)

Team Members: Dr Sally Wortley (PBAC), Clarice Moreira Portugal (CONITEC Brazil), Dr Grace Li-Ying Huang (HTA Center for Drug Evaluation, Taiwan), Elisabeth Oehrlein (National Health Council), Marjo Forsblum (Lung Cancer Europe), Zorana Maravic (Digestive Cancers Europe), Lise-Lott Eriksson (Blood Cancer Org Swe), Barry Liden (Edwards Lifesciences), Stephanie Manson/Pete Murphy (Novartis), Hayley Andersen (BMS), Franz Waibel (Consultant)

Further Information:

• Project Description
  • Project Proposal
• Current Status Report
  • 010 November Update
  • March 2022 Update
• Other Material
  • Plain language summaries of applications to HTA bodies for patient groups: Template | Overview
  • Guidance for industry | HTA bodies | Patient groups
  • Open Access Paper: Cook, N., Livingstone, H., Dickson, J., Taylor, L., Morgan, K., Coombes, M., . . . Liden, B. (2021). Development of an international template to support patient submissions in Health Technology Assessments. International Journal of Technology Assessment in Health Care, 37(1), E50. doi:10.1017/S0266462321000167
  • See PAST PROJECTS for Summary of Information for Patients project #003

Project #012

Aim: Build on pass work to generate HTAi guidance to ensure meaningful, welcoming and well-supported patient and public involvement at HTAi Annual Meetings.

Team Members: Sarah Berglas (CADTH, Canada) David Chandler (lay member UK), Paula Orecklin (patient member, Canada), Ann Single (Patient Voice Initiative, Australia), Valentina Strammiello (European Patients Forum, Belgium), Dorota Zgodka (independent consultant.)

Further Information:

• Project Description
  • Project Proposal
• Current Status Report
  • January 2022 Update
  • March 2022 Update
• Other Material
  • NIL

Project support

• Lessons from past projects.
• Project Sub-COmmittee Proposal
• Project Update template
• PCIG Terms of Reference
• Project Proposal Guidance

Since it began in 2005, PCIG has developed a reputation for providing practical products to meet the needs of those working in patient involvement in HTA. These projects haves been characterised by an inclusive approach which recognises the value of robust evidence, multi-stakeholder expertise and wide consultation.

There are no set criteria for project proposals. The key requirement is to identify a need related to patient involvement in HTA and then put together a sub-committee to scope and complete the project with appropriate oversight from the Steering Committee and consultation with the wider Interest Group. The projects can be short or long and with large or small goals. Typically, PCIG projects address areas such as developing involvement and educational materials and processes, exploring methodological issues, developing resources and tools which can be used or adapted by others.

The PCIG Steering Committee will approve up to eight projects at any one time. Each Project Sub-Committee shall have a lead and up to 12 members. Members of Project Sub-Committees must be members of PCIG and Project Sub-Committees must provide quarterly reports to the Steering Committee for publication on the website.

For more information, contact the PCIG Project Coordinator, Anke-Peggy Holtorf, email: PCIG_Proj@health-os.com