Tag: patient involvement

  • Four reasons for involving patients in improving research (plus the one that matters most)

    Four reasons for involving patients in improving research (plus the one that matters most)

    There has been a lot of research on why patients should be involved in improving research. The arguments usually sound convincing — but they often miss the real point. Here are the four most common reasons, and the reason that I think should always be mentioned first. I have also added some scientific references at the end in case you want to dive deeper.

    Reason 1: It’s the morally and ethically right thing to do

    The literature repeatedly frames patient involvement as an ethical obligation. It respects autonomy, promotes justice, values lived experience, and strengthens accountability. Instead of treating patients as passive subjects, involvement recognises them as partners with a legitimate claim to influence research that affects their lives. It also fits democratic ideals: publicly funded research should be transparent, fair, and responsive to those it serves.

    All true.
    But ethics alone rarely changes research practice.

    Reason 2: It improves research design

    When patients help shape questions and protocols, studies tend to become more relevant and feasible. Patient input can sharpen outcome selection, clarify consent materials, refine inclusion criteria, and reveal practical burdens researchers miss. Involving patients early makes studies look less elegant on paper — but more workable in reality.

    Good design is a strong argument.
    Still, it doesn’t explain why patient input makes design better in the first place.

    Reason 3: It improves participant recruitment and retention

    Patient involvement can make studies clearer, more acceptable, and more trustworthy. When study materials reflect patient perspectives, people are more willing to enrol and stay engaged. Collaboration also signals partnership rather than extraction, which strengthens trust — and trust drives participation.

    Useful, yes.
    But recruitment is a downstream effect, not the core reason.

    Reason 4: It improves value for money

    Studies that ignore patient realities are more likely to struggle with recruitment, require redesign, or produce findings that never get implemented. Involving patients early can reduce waste, improve efficiency, and increase the chance that research investments actually lead to change.

    This argument resonates with funders.
    But it still treats involvement as a tool for optimisation, not as a core part of knowledge production.

    Reason 5: Patients have knowledge researchers don’t

    Here’s the real reason.

    Patients and researchers don’t just have different views — they have different epistemic positions. Researchers are trained to generate analytic, comparative, and generalisable knowledge from the outside. Patients develop situated, embodied, and longitudinal expertise from the inside. They know how illness unfolds over time, how treatments collide with everyday life, how systems behave in practice, and how decisions are made under real constraints.

    This isn’t anecdotal input. It’s operational knowledge of how health and care actually work.

    When that knowledge is missing, research often rests on assumptions that seem reasonable to professionals but fail in real life. When it’s present, studies are more realistic, interpretations make more sense, and implementation becomes possible.

    The reason patient involvement improves research is not primarily ethical, financial, or procedural.
    It’s epistemic.

    Conclusion

    Ethics, design quality, recruitment, and efficiency are all good reasons to involve patients. But they are secondary. The fundamental reason is that research improves when it integrates both outside analytic expertise and inside lived expertise. Without that combination, we risk producing studies that are methodologically sound — and practically wrong.

    (Secondary) patient involvement isn’t mainly about being nice, fair, or efficient — it’s about fixing a knowledge gap in research that only patients can fill.

    References

    • Beresford, P., & Russo, J. (2020). Patient and public involvement in research. In Achieving Person-Centred Health Systems.
    • Boivin, A., Richards, T., Forsythe, L., Grégoire, A., L’Espérance, A., Abelson, J., & Carman, K. (2018). Evaluating patient and public involvement in research. BMJ, 363. 
    • Domecq JP, Prutsky G, Elraiyah T, Wang Z, Nabhan M, Shippee N. Patient engagement in research: a systematic review. BMC Health ServRes. 2014;14.14
    • Dumez, V. and A. L’Espérance, “Beyond experiential knowledge: a classification of patient knowledge,” Soc Theory Health, Jun. 2024,
    • Frank L, Basch E, Selby JV, Patient-Centered Outcomes Research I. The PCORI perspective on patient-centered outcomes research. JAMA. 2014;312:1513-1514.13. 
    • Hoos A, Anderson J, Boutin M, et al. Partnering with patients in the development and lifecycle of medicines: a call for action. TherapeuticInnovation & Regulatory Science. 2015;49:929-939.
    • Levitan B, Getz K, Eisenstein EL, et al. Assessing the Financial Value of Patient Engagement: A Quantitative Approach from CTTI’s Patient Groups and Clinical Trials Project. Ther Innov Regul Sci. 2017.
    • Røssvoll, T. B., Rosenvinge, J., Liabo, K., Hanssen, T. A., & Pettersen, G. (2023). Patient and public involvement in health research from researchers’ perspective. Health Expectations, 26, 2525–2531.
    • Sacristán, J. A., Aguaron, A., Avendaño-Solá, C., Garrido, P., Carrión, J., Gutiérrez, A., Kroes, R., & Flores, A. (2016). Patient involvement in clinical research: why, when, and how. Patient Preference and Adherence, 10, 631–640.
    • Smith MY, Hammad TA, Metcalf M, et al. Patient engagement at a tipping point—the need for cultural change across patient, sponsor, and regulator stakeholders: insights from the DIA Conference, “Patient Engagement in Benefit Risk Assessment Throughout the Life Cycle ofMedical Products.” Therapeutic Innovation & Regulatory Science. 2016;50:546-553
    • Staley K, Minogue V. User involvement leads to more ethically sound research. Clin Ethics. 2006;1:95-100.12. 
  • Checklist and resources for meaningful engagement of patients

    Checklist and resources for meaningful engagement of patients

    This post is a followup of my recent post Why are patients the only ones around the table expected to work for free? In this new post, I have made a checklist and compiled some resources that may be useful for for patients when invited to contribute to for example research, care improvement, conferences, products, etc.

    The term “meaningful engagement” that I have used in the title comes from a WHO report that was published in 2023, and can be found under Resources further down.

    I see meaningful engagement as engagement that leads to meaningful change.

    Checklist

    First the checklist, let me set the scene:

    You have received an invitation of some sort to contribute in some way… In my experience, often the person inviting you is not entirely sure what they want your help with. They have heard, maybe from their boss, their colleagues or someone else, that it is very important to involve patients. Maybe they don’t fully understand why, and that’s OK. For me, many great collaborations have started with a very unclear beginning. The key factor is if the person contacting you have the right mindset and the only way to establish that is by interacting with them. It can take some time but my experience is that it is worth investing that time early on instead of encountering difficult issues later in the process.

    I hope the checklist below can help you. Use it to quickly assess whether the invitation treats you as a knowledge contributor or as free labor.

    1) Clarify the role

    2) Clarify the expectations

    • How many meetings? How long?
    • What preparation is expected?
    • Will I be asked to read materials in advance?
    • Are follow-ups or written feedback expected?

    If preparation is required → this is work.

    3) Ask directly about compensation

    • Is there an honorarium or hourly compensation?
    • Are preparation time and meeting time both compensated?
    • Are travel time and expenses covered?

    If the answers are vague, that’s a signal.

    4) Watch for “replacement compensations”

    Be alert if you hear:

    • “You’ll get visibility / contacts”
    • “You can use our system/app for free”
    • “Others do this voluntarily”
    • “There is no budget”
    • “It’s complicated administratively”

    These are red flags, not benefits. For common arguments and counterarguments, see this post.

    5) Check how professionals are treated

    • Are the researchers/organizers/project team members doing this during paid work hours?
    • Are speakers, consultants, or moderators paid?

    If yes → the principle should apply to you.

    6) Ask how your input will be used

    • How will my contribution be documented?
    • Will I receive feedback on how it influenced the project?
    • Is this advisory or actually consequential?

    Vague answers often mean symbolic involvement.

    7) Consider accessibility and fairness

    • Would someone without financial flexibility be able to say yes to this?
    • If not, the setup is structurally excluding many patients.

    8) Ask for it in writing

    • Role description
    • Time expectations
    • Compensation terms
    • Reimbursement of expenses

    If it feels uncomfortable for them to write it down, that’s informative.

    9) Decide your boundary

    You can say:

    “I’m happy to contribute, but I don’t do this type of work without compensation.”

    This is not rude. It is professional.

    10) Remember

    You were invited because of what you know.
    That knowledge has value.

    Resources

    Below, I have listed some resources that support meaningful engagement.

    WHO framework for meaningful engagement of people living with noncommunicable diseases, and mental health and neurological conditions

    Link to document

    Highlights:

    • Target audience: Member States and other stakeholders
    • “The overall objective of the framework is to support WHO and Members States in meaningful engagement of people living with NCDs, and mental health and neurological conditions to co-create and enhance related policies, programmes and services.”
    • Practical advice and recommendations
      • 4. Principles of meaningful engagement
      • 5.1 Sustainable financing. Meaningful engagement should be supported by sustainable financing for all engagements with individuals with lived experience remunerated at a rate equivalent to that for technical experts.
    • Conclusions:
      • A lot of work still remains
      • The way forward lies in collaboration

    WHO Guidance for best practices for clinical trials

    Link to document

    Highlights:

    • Target audience: Everybody working on clinical trials
    • “strengthening clinical trials to provide high-quality evidence on health interventions and to improve research quality and coordination to identify and propose best practices and other measures to strengthen the global clinical trial ecosystem and to review existing guidance and develop new guidance as needed on best practices for clinical trials.”
    • Main focus is RCTs
    • Emphasizes meaningful engagement:
      • 2.2 Good clinical trials respect the rights and well-being of participants
      • 2.3.1 Working in partnership with people and communities
      • 3.2.1 Patient and community engagement

    Update to the Declaration of Helsinki

    I have also written a blog post on the update to the Declaration of Helsinki, the post is in Swedish, use your favorite translator to read it: Link to post

  • Why are patients the only ones around the table expected to work for free?

    Why are patients the only ones around the table expected to work for free?

    (Detta inlägg finns även på svenska: LÄNK)

    (This post is complemented with a checklist: LINK)

    I have been part of literally hundreds of conversations and meetings with researchers, healthcare professionals, companies, agencies, conference organizers and others wanting to involve patients. Here, I have listed 12 arguments that I have heard when asking if the offer comes with some form of payment (plus one bonus argument, which I think is the true reason that patients are often expected to work for free)

    First, let’s make sure that we’re talking about the same thing:

    Primary or secondary patient involvement?

    When I teach or present on patient involvement, I always spend some time at the start to ensure that we all agree on what we’re talking about. If the topic is how to engage patients in participating in research studies or clinical trials, I refer to it as primary patient engagement. For conversations on getting patient input on the structure and/or process of studies or trials to improve them for upcoming participants, I use the term secondary patient engagement. I have written about this before => link to post.

    Many regulatory bodies, research funders, governmental authorities and others all around the world are increasingly promoting, encouraging, and even demanding secondary patient engagement for applications and projects. And that is what this post is about: secondary patient engagement.

    I want to point out that the same principles apply to engaging patients to help improving healthcare processes or facilities, medtech products, evaluating research applications, speaking at conferences etc.

    Here we go, 12 arguments I’ve heard on why not to pay patients:

    (edit: now with five additional arguments, based on comments and feedback, between reasons 12 and 13)

    Reason 1: “This is voluntary engagement, not work”

    Imagine a project meeting where a researcher, a clinician, a project manager—and a patient—are all invited to help improve a study design. The meeting has an agenda, background material is sent out in advance, and everyone is expected to read it, think it through, and contribute informed input.

    The researcher, clinician, and project manager are all attending as part of their paid workday. The patient is described as “volunteering.”

    Yet the expectations are the same: show up on time, be prepared, share expertise, and help shape decisions the project depends on. The only real difference is how the contribution is labeled—and whether it is compensated.

    How can this argument be met?

    Counterarguments

    • The tasks are defined, scheduled, and requested by the organization → this is work.
    • Volunteering is initiated by the individual. Here, the system initiates.
    • This is organized knowledge work, not volunteering.

    Reason 2: “Compensation threatens independence”

    Imagine the same meeting where everyone is paid for their time—except the patient, who is told that payment might make their input less independent. The implication is that being unpaid makes their perspective more trustworthy. Strangely enough though, the paid professionals’ independence is never questioned.

    Counterarguments

    • Everyone else in the room is paid without their independence being questioned.
    • Transparency about compensation increases credibility.
    • Independence is secured by transparency, not by lack of payment.

    Reason 3: “But researchers (doctors, nurses, etc) do this (review funding applications, sit on advisory boards, present at conferences, etc) without payment”

    No, they don’t. This argument overlooks that these activities usually take place within paid employment, during salaried work hours, and contribute to professional merit, networks, and career progression. What appears as “unpaid” is in fact embedded in a system where time, status, and long-term benefit are already compensated. Patients, in contrast, are expected to contribute outside any such structure.

    Counterarguments

    • For professionals, this work happens within paid roles and paid time; for patients, it does not.
    • These activities build careers and merit for professionals—patients receive no equivalent benefit.
    • What looks unpaid for staff is still supported by salary, status, and infrastructure; patients stand outside all three.

    Reason 4: “There’s no budget for paying patients”

    Another type of argument relates to financial aspects. It is often said that compensation simply wasn’t planned for, as if budgets were fixed facts rather than reflections of priorities. Yet the same project easily finds funds for venues, catering, consultants, and staff time—which simply means that the real issue is not lack of money. It’s about what the organization sees as important.

    Counterarguments

    • Budget reflects priorities, not constraints of nature.
    • The same budgets accommodate consultants and communication activities.
    • If it is not in the budget, it is because it was deprioritized.

    Reason 5: “It’s so administratively complicated”

    This argument points to practical hurdles—tax forms, payment systems, insurance, procurement rules—as if these were insurmountable barriers. But the very same administrative machinery routinely handles fees for consultants, speakers, and external experts. What it reveals is not true complexity, but that the system was never designed with patients in mind as formal contributors.

    Counterarguments

    • The system already manages consultant fees and honoraria.
    • “Complicated” means the organization has not adapted to patients as contributors.
    • Administrative systems should adapt to reality, not the other way around.

    Reason 6: “We don’t want to create ‘professional patients’”

    This argument reflects a concern that some patients might become too experienced, too familiar with research and healthcare processes, and therefore somehow less “authentic.” The strange thing is that in every other context, growing competence and repeated involvement are seen as assets that improve quality. What is framed as a risk here is, in practice, the very process by which expertise is developed.

    Counterarguments

    • What is being described is competence development.
    • We do not question “professional researchers”.
    • Competent patients are an asset, not a threat.

    Reason 7: “We are giving patients a chance to contribute to research / future patients / their own community”

    This frames participation as a gift to the patient rather than a contribution to the project. It suggests that the opportunity to be involved is itself a form of compensation, shifting attention away from the value the patient adds. In doing so, requested work is seen as a favor granted, rather than expertise sought.

    Counterarguments

    • Being invited is not compensation when real work and expertise are requested.
    • Calling it a “chance to contribute” reframes sought-after expertise as a favor instead of a contribution.
    • It is frankly unethical to try to shame patients, who often are struggling with illness, worry and financial hardship, into contributing for free.

    Reason 8: “Patients benefit from participating”

    This is an especially infuriating argument, that patients should not be paid because they get benefit from their contributions in the form of strengthening of health and motivation. This argument suggests that any personal health gains a patient might experience from being involved somehow replace the need for compensation. It implies that improved understanding, empowerment, or a sense of purpose is “payment enough.” By that logic, however, no one whose work is meaningful, educational, or professionally rewarding would ever need a salary.

    Counterarguments

    • Researchers also benefit personally from salary and career advancement. So, by the same logic, they should also not get paid.
    • Personal benefit does not negate that something is work.
    • Self-interest does not disqualify work—otherwise no one would be paid.

    Reason 9: “Compensation could attract the ‘wrong kind of patients’”

    This argument assumes that financial motivation makes participation less genuine, as if only those who can afford to contribute for free are the “right” voices. In practice, it means that unpaid involvement filters out anyone without spare time or financial flexibility. Rather than protecting quality, it quietly ensures that only the most privileged patients are able to take part.

    Counterarguments

    • This argument is never applied to professionals.
    • Compensation enables participation from those who otherwise cannot afford it.
    • Without compensation, you only recruit the economically privileged.

    Reason 10: “Patients don’t know enough about what we do for us to pay them”

    This argument suggests that patients lack the technical understanding required to warrant compensation, as if payment were reserved only for formal expertise. Yet patients are invited precisely because they bring a different kind of knowledge—about living with a condition, navigating care, and seeing gaps professionals may overlook. Dismissing this as insufficient knowledge overlooks the very reason they were asked to contribute in the first place.

    Counterarguments

    • Patients are invited for what they know that professionals don’t—not for what they lack.
    • You’re compensating contribution and time, not academic credentials.
    • If their knowledge isn’t valuable, they shouldn’t be in the room in the first place.

    Reason 11: “We’ve never paid patients before”

    This argument rests on tradition: it has always been done this way, so it feels natural to keep doing it. But history mostly tells us how things used to work—not whether they still make sense. Many of the improvements in patient involvement have come from challenging exactly these old routines.

    Counterarguments

    • Tradition is not an argument in knowledge development.
    • Patient involvement as a field exists precisely to change past practice.
    • Historical practice is the reason patient knowledge has been underused.

    Reason 12: “Not all patients want to get paid” or “Not all patients are able to accept payment”

    This argument points out that some patients prefer to contribute without compensation, or may be restricted by benefit rules or employment status. While this may certainly be true for some individuals, it turns a personal choice into a general rule for everyone. The fact that a few people are willing—or forced—to work for free does not mean that unpaid work should be the norm.

    Counterarguments

    • Individual preference should not define the norm for everyone else.
    • The option to decline payment is fair; the absence of payment is not.
    • Basing the system on who can afford to work for free excludes those who can’t.

    These additional reasons have been added as a result of comments and feedback:

    Additional reason 1: “We can’t pay you, but you’ll get great connections by speaking at our conference”

    This frames visibility and networking as a substitute for compensation. It assumes that exposure, contacts, or prestige are adequate payment for preparation time, travel, and sharing expertise. In practice, it mirrors a pattern where patients are expected to trade real work for intangible benefits that primarily serve the organizer.

    Counterarguments

    • Exposure and networking do not replace compensation for time and expertise.
    • Professionals invited to speak are rarely asked to accept “connections” instead of payment.
    • If the talk creates value for the conference, it deserves proper compensation

    Additional reason 2: “We can’t pay you, but you can use our app/AI bot/system for free”

    This argument reframes access to a product or service as a form of compensation. It treats the patient’s time and expertise as something that can be exchanged for exposure, testing access, or early use of a tool. In reality, this shifts the relationship from collaboration to unpaid product testing, where the patient’s contribution creates value for the company or project without any financial recognition.

    Counterarguments

    • Access to a product is not compensation for professional input and time.
    • This turns patient involvement into unpaid user testing.
    • If the tool has real value, it should be offered in addition to fair compensation—not instead of it.

    Additional reason 3: “We can’t pay you, but why don’t you fundraise to cover your own costs and then contribute for free?”

    This argument asks the patient to take on the financial responsibility for enabling their own participation, while everyone else is paid from the project’s budget. It turns involvement into a personal funding problem and shifts the burden of resourcing the project onto the very person whose knowledge is being requested.

    Counterarguments

    • Asking someone to fundraise to work for free reverses who is responsible for resourcing the project.
    • No other contributor is expected to secure their own funding to be allowed to participate.
    • If the contribution is important enough to ask for, it is important enough to budget for.

    Additional reason 4: “We’d love to pay you – but how?” (followed by silence)

    This starts as apparent goodwill: praise for your contribution and an expressed intention to compensate you. You provide the requested invoice or details—and then nothing happens. Months pass. A year later, you’re warmly invited back because your previous input was “so valuable,” while the earlier payment is still unresolved.

    Counterarguments

    • Good intentions without follow-through are functionally the same as not paying.
    • If an organization can manage contracts and payments for others, it can do the same for patients.
    • Unpaid past work should be resolved before new involvement is requested.

    Additional reason 5: “If you won’t do it, we will find someone else who will”

    This argument relies on the fact that some patients, out of goodwill, passion, or necessity, are still willing to contribute for free. It shifts the focus from fairness to replaceability, implying that the issue is not the value of the contribution but the willingness of someone to accept unpaid work.

    Counterarguments

    • The availability of unpaid contributors does not make unpaid work ethical.
    • Replaceability does not reduce the value of the contribution.
    • This approach selects for who can afford to work for free, not for who is best suited to contribute.

    Reason 13: The unspoken underlying argument

    The real, unspoken argument is probably:

    “If we start paying patients, we acknowledge that their knowledge is work. And that challenges the existing knowledge hierarchy”

    This is not about money. It is about epistemic status.

    Counterarguments

    • Yes — that is the point.
    • If patients contribute to knowledge production, they are knowledge actors.
    • Compensation is an organizational recognition of this.

    This is about how we view knowledge, not about money.

    Here is an argument that can be used to close:

    Either this is a real contribution to research and healthcare improvement — and should be compensated.
    Or it is symbolic participation — and we should be honest about that.

    Which ones have you heard? Have you heard any other arguments for not paying patients? Let me know in the comments.

  • This is why patient involvement is important for improving healthcare or “It seems inconvenient, but if you really want to, you can try”

    This is why patient involvement is important for improving healthcare or “It seems inconvenient, but if you really want to, you can try”

    (This blog post is also available in Swedish =>> here)

    Most people living with Parkinson’s disease take a lot of pills, multiple times a day. After having Parkinson’s for a while, it’s not uncommon to be prescribed 3-4 different types of medications to be taken in various combinations 4-6 times each day. One of my medications is an extended-release type, which means that the pill slowly dissolves in the body, and therefore, at least in theory, it’s sufficient to take it only once a day. When I started taking that medication, I did exactly that, took it once every day, in the morning. After the usual “adjustment problems” such as a bit of nausea and similar issues for a few weeks, I felt confident that the addition of this medication did indeed make it a bit easier for me to move around.

    After some time however, I noticed that the positive effect was noticeable in the morning but the pill didn’t give me as much of an effect later in the afternoon. During my next neurologist visit, I mentioned this to him. I knew that the same medication was available also in other dosage strengths so I asked him if maybe he could prescribe it to me in a lower strength so that I could spread out my intakes of the extended-release formulation over the day. In this way, I could take lower doses at several different times instead of taking only one higher dose tablet in the morning. He considered this for a few seconds and said: “According to the information from the pharmaceutical company, it really should be enough to take this medication only once a day, and it does seems inconvenient to take it at multiple times. But if you really want to, you can try.” I left the clinic with a new prescription and was curious to see how this new dosing would work out.

    Classification of patient knowledge by source of learning. (From: Dumez, V., & L’Espérance, A. (2024). Beyond experiential knowledge: A classification of patient knowledge. Social Theory & Health.)

    It should come as no surprise that I strongly believe that the improvement of healthcare should be done together with patients, and I recently came across a scientific article that made me see patient involvement in a completely new light: “Beyond experiential knowledge: a classification of patient knowledge” written by Vincent Dumez and Audrey L’Espérance. They identify six types of patient knowledge from three main sources of patient learning, see the Figure. You can read a separate post about that article here, and most important is that Dumez and L’Espérance made me aware of the concept of patients’ experiential knowledge. I also went through that article’s reference list (a good way to find other relevant scientific articles in a particular field) and found a very interesting article published back in 1976: “Experiential Knowledge: A New Concept for the Analysis of Self-Help Groups” written by Thomasina Borkman. There, experiential knowledge is described as “first-hand knowledge,” meaning knowledge obtained from personal experience with a phenomenon, as opposed to knowledge that comes from reasoning, observation, or reflection based on information provided by someone else. I have written a separate post also for this article (link here).

    So what? Why is this important?

    What does this mean then? In what way do these two scientific articles relate to patient involvement? This is my take: Through their education and professional work, healthcare professionals have acquired theoretical knowledge. They have also gained experiential knowledge through their professional practice. Of course, both of these aspects are very important when you want to improve and further develop healthcare. And if you live 24/7 with illness, disabilities, and the need for help and support from healthcare and society, AKA patients, you gain experiential knowledge. That kind of knowledge cannot be gained theoretically. You cannot get experiential knowledge from reading a textbook or a scientific article, it can only be acquired through living it.

    This means that without also having direct access to patients’ experiential knowledge, healthcare professionals do not have the full picture and therefore cannot solve the problem at hand: to optimize individual health, in the best way.

    Finally

    You might wonder what happened when I started taking the extended-release medication several times a day instead of just once every day. Well, as usual when making medication changes, there were some initial adjustment issues when I went from a higher dose once a day to several lower doses. After that, it became very clear to me that this way of using the medication gave me a noticeably more consistent effect. I shared this with my neurologist, and later I heard from other people with Parkinson’s who also go to him that he started prescribing this extended-release tablet in the same way to other patients as well.

    In conclusion: involving patients in improving and further developing healthcare is important because it ensures that healthcare is based on the actual priorities that patients have, rather than the priorities that healthcare professionals think that patients have.