Not Just Patients

On this episode, Dr. Anke-Peggy Holtorf joins us to help demystify the complex processes of regulatory affairs and health technology assessment (HTA) and explain the crucial role of patients in these processes.
Anke acts as Secretary of the Board at Health Technology Assessment international and is a Steering Committee member and project coordinator for the Patient and Citizen Involvement in HTA Interest Group. She is co-editor of the 2nd edition of the book on Patient Involvement in HTA, which will be published in 2025. Anke has also taught graduate courses in International Health Policy, HTA, and the role of patient involvement.
Anke's global experience and depth of knowledge spanning decades shine through as she simplifies some highly technical and complex concepts for our listeners.
Chapters:
0:00 - Introductions
1:34 - Overview of regulatory affairs and HTA
6:48 - The regulatory approval process
12:09 - Patient involvement in regulatory affairs
22:19 - Overcoming barriers to patient involvement
27:32 - Regulatory success rates
30:30 - The HTA process
32:32 - Differences in healthcare models
36:46 - Factors evaluated in HTA
43:45 - Patient involvement in HTA
54:32 - Advice for patients and stakeholders
59:08 - Reflections with Caitlin and Clarinda
Resources and definitions:

• HTA - Health Technology Assessment
• Reimbursement: the process by which healthcare providers are compensated/paid back for the medical services they provide, either by the government or through insurance
• Out-of-pocket costs: when patients pay for their own medical costs
• FDA - US Food and Drug Administration
• EMA - European Medicines Agency
• Chinese FDA
• QALY - Quality adjusted life years
• WHO - World Health Organization
• NICE - National Institute for Health and Care Excellence, UK
• CF Trust - Cystic Fibrosis Trust
• EUPATI - European Patients' Academy on Therapeutic Innovation
• EUCAPA - European Capacity Building for Patients
• Anke's report on Patient Involvement in HTA in Europe - full report and short version

Have feedback or suggestions for us? We'd love to hear from you!
Website: notjustpatients.com
LinkedIn: Not Just Patients
Email: [email protected]

In this episode, we speak to Dr. Victor Montori about the importance of shared decision-making in healthcare.
Dr. Montori is the Robert H. and Susan M. Rewoldt Professor of Medicine at Mayo Clinic. An endocrinologist, health services researcher, and care activist, he is the author of more than 750 peer-reviewed publications and is among the most cited researchers in clinical medicine and in social science. He is a recognized expert in evidence-based medicine, shared decision making, and minimally disruptive medicine. He is also the author of the book Why We Revolt, and is leading a movement, a Patient Revolution, for Careful and Kind Care for all.
In our conversation, we discuss the need for patient-centred care that involves and respects individuals as holistic beings, the challenges that inhibit shared decision-making in practice, and the broader societal need to foster self-care and community support.
Chapters
0:00 - Introductions
1:40 - What is shared decision-making?
5:30 - Careful and kind care
9:24 - Forms of shared decision-making
14:58 - Victor's motivation
18:50 - How much time should doctors spend?
23:20 - Is shared decision-making for all patients?
27:15 - Who is responsible for shared decision-making?
31:28 - Where can clinicians learn shared decision-making?
35:46 - A Patient Revolution
44:25 - Barriers to overcome
50:08 - Tackling an insurmountable challenge
55:43 - Reflections with Caitlin & Clarinda

Have feedback or suggestions for us? We'd love to hear from you!
Website: notjustpatients.com
LinkedIn: Not Just Patients
Email: [email protected]

On this episode, we talk to Robert Joyce about the critical role of patient involvement in clinical research and the various ways in which patients can bring rich perspectives to the research and development process.
Robert has lived with chronic illness all his life, but following a traffic accident in 2014, he was left with debilitating symptoms. No longer able to work, Robert started his blog, a 30 minute life, to share his experiences, and also has a podcast of the same name.
In 2019, Robert also became involved in clinical research, eventually earning the title of Embedded Patient Researcher and becoming a co-applicant on the trial of a therapy for Multiple Sclerosis. Unfortunately he was not permitted to continue in this role, but is now an advocate for more patients to be involved in research.
Chapters:

0:00 - Introductions

1:25 - Role of an embedded patient researcher

8:10 - Benefits of patient involvement in research

15:56 - Different ways patients can be involved in research

23:08 - Role of country/disease-specific patient organisations

25:08 - Challenges and initiatives for rare diseases

27:37 - Initiatives to bring patients closer to research

29:10 - Robert's story and personal challenges

33:55 - Challenges to patient involvement

35:44 - What needs to be done to overcome barriers

44:22 - Engaging funders in patient involvement

51:30 - Advice for patients looking to get involved

53:01 - Advice for stakeholders looking to involve patients

55:38 - Reflections with Caitlin and Clarinda

Have feedback or suggestions for us? We'd love to hear from you!
Website: notjustpatients.com
LinkedIn: Not Just Patients
Email: [email protected]

On this episode, we speak to Avishek Pal about how patients can better access and contribute to medical publications.
In parallel to his day job as Global Medical Director of Cell & Gene Therapy at Novartis, Avishek is affiliated with the Institute for Biomedical Ethics at University of Basel, investigating how medical research information in plain language may improve health literacy and autonomy in patients with chronic diseases.
Join us as we discuss how patients seek medical information, the role of generative AI, and initiatives fostering better patient access and involvement in medical literature.
Chapters:

• 0:00 - Introductions
• 1:48 - Patients' information-seeking patterns
• 4:38 - Role of health literacy
• 6:21 - Importance of accessing medical literature
• 8:44 - Information overload & reliability
• 15:24 - Plain-language summaries
• 26:43 - Publication bias in medical research
• 30:54 - AI for medical information
• 39:25 - Patients as authors
• 49:53 - Future of medical publications
• 53:15 - Advice for different stakeholders
• 56:44 - Reflections with Caitlin & Clarinda
  

Resources and abbreviations:

• Cochrane Library
• Pubmed
• Google Scholar
• CF - cystic fibrosis
• Avishek’s landscape analysis paper on plain-language resources
• Future Science Group, now a part of Taylor & Francis
• Becaris Publishing
• Envision Group
• A&E - accident and emergency
• CF Trust - Cystic Fibrosis Trust
• NHS - National Health Service, UK
• CDC - US Centres for Disease Control and Prevention
• NIH - National Institutes of Health, US
• FDA - US Food & Drug Administration
• EMA - European Medicines Agency
• Chat-GPT
• Avishek's paper on ethical considerations for plain-language materials
• EUPATI - European Patients’ Academy on Therapeutic Innovation
• PIF TICK
• Discern
• ICMJE (International Committee of Medical Journal Editors) authorship criteria
• Clarinda’s Patient Perspective paper
• Coalition S

Have feedback or suggestions for us? We'd love to hear from you!
Website: notjustpatients.com
LinkedIn: Not Just Patients
Email: [email protected]

On this episode, we speak to Mark Duman, Chief Patient Officer at MD Healthcare, about digital health and health data, how digital therapeutics get developed and approved, and how challenges around access and equity can be navigated.
Mark is a clinician, management consultant, and patient advocate who works with several healthcare organisations to harness digital health, improve market access, and embed patient engagement in healthcare products and services.
Join us for this insightful conversation on a hot and rapidly evolving topic.
Chapters
0:00 - Introductions
1:47 - Mark's story
3:46 - Scope of digital health and health data
6:11 - Enhancing patient care
12:15 - Patient engagement
14:44 - Regulations and reimbursement
21:59 - Challenges around access and equity
28:55 - Development process and patient inclusion
37:35 - Data privacy and ethics
47:18 - Future of digital health
52:57 - Advice for patients/stakeholders
56:39 - Reflections with Caitlin and Clarinda

Resources/abbreviations

• Cerner system for electronic health records
• QALY – quality-adjusted life years
• WALY – wellbeing-adjusted life years
• Salford Lung Study
• PREMS – patient-reported experience measures
• PROMS – patient-reported outcomes measures
• ABPI - Association of the British Pharmaceutical Industry
• ABHI - Association of British HealthTech Industries
• EUPATI Patient Engagement Roadmap
• DTA - Digital Therapeutics Alliance
• DIME – Digital Medicine Society
• NICE – National Institute for Health and Care Excellence, UK
• Sleepio
• Nesta report
• CE Mark
• DTAC – Digital Technology Assessment Criteria
• DTS (data security and protection) toolkit
• Scotland’s Patient Experience Programme
• Flatiron Health Patient Voices Panel
• GDPR - General Data Protection Regulation
• Information Governance Toolkits
• HMO - health maintenance organization
• ZOE Study
• Lloyd’s Bank Consumer Digital Index
• Patient Innovation

Have feedback or suggestions for us? We'd love to hear from you!
Website: notjustpatients.com
LinkedIn: Not Just Patients
Email: [email protected]