Clarifying the roles of patients in research
BMJ 2018; 361 doi: https://doi.org/10.1136/bmj.k1463 (Published 10 April 2018) Cite this as: BMJ 2018;361:k1463
All rapid responses
A comprehensive case study of how patients were first included as partners in an international Rheumatology research group, and how this has evolved and developed over 14 years helps to demonstrate the difference between partnership and the more general phrase of 'participation'. This is provided in a series of papers referenced in this open access review:
de Wit M, Kirwan JR, Tugwell P, et al. Successful stepwise development of patient research partnership: 14 years’ experience of actions and consequences in outcome measures in rheumatology (OMERACT). The Patient, 2017; 10: 141–152. DOI 10.1007/s40271-016-0198-4
Competing interests: No competing interests
Thank you for your engaging responses to our editorial. We are particularly encouraged that a BMJ editorial now engages patient advocates as well as researchers. We thank Mr deBronkart for his observation that the patient community is also not one homogenous group, yet the role has changed for all patients.
Reading two of these comments we realise that for those who work with patients as active and equal research partners, our views on role descriptions and conflation might seem rather archaic. The text for this editorial was informed by our experiences of running involvement advice clinics, in addition to individual experiences of working with research colleagues on grant applications, across the UK. One of us has experience of also being involved in research as a patient expert. Our experiences do not only draw from participatory research designs, but from a whole range of designs not usually associated with involving patients as partners, for example: randomised controlled trials, systematic reviews and diagnostic studies.
We do not suggest that ethical research is difficult to do in partnership situations. On the contrary we agree with Professor Shanahan that true partnership with patients can contribute to ethical research. The problem arises when patient partnership is conflated with pilot studies, qualitative research, focus groups and other data collection methods. This can result in shoddy ethical practices, poor quality research and patients who are not partners but merely respondents to questions set by researchers.
We agree with Professors Shanahan and Checkland that there are several research designs in which participants also hold partner roles and we cite a paper by Morgan et al (2016) as a good example. As Professor Checkland suggests, health researchers in the UK and beyond have much to learn from community-based participatory research and similar designs. We hope this is conveyed in our editorial, and wish there had been space to elaborate on this point. One of us has published elsewhere about the need to go beyond ‘consent’ in ethical research conduct (Liabo, Ingold and Roberts 2017).
Professor Shanahan states that clarification of roles is important in all partnership collaborations and we couldn’t agree more. However, our experiences tell us that while clinicians and managers are usually invited to the research partnership as equal partners, this does not always happen for patients and public contributors. We have found that some researchers believe running a ‘focus group’ with patients equates to patient involvement in research, and that such a focus group can double up as qualitative research. This is the scenario which we propose constitutes ethical misconduct. Patient partners may well choose to be participants in the research study as well as members of the study team. But taking part in a focus group is not the same as influencing the decisions made on that research. We maintain that there can be ethical challenges to research where these roles overlap. Research is a human activity and its ethics are therefore always challenging, rarely clear cut and “accepting ambiguity and uncertainty is not a mistake, but an unavoidable result of the human condition” (de Melo-Martin 2009: 1245).
Competing interests: none
Liabo K, Ingold A, Roberts H. Co-production with “vulnerable” groups: balancing protection and participation. Health Science Reports, 2017: e19, Online version 6th December, DOI: 10.1002/hsr2.19
de Melo-Martín, I. The art of medicine. Vulnerability and ethics: considering our Cartesian hangover. The Lancet 2009:373(9671); 1244-5, DOI: https://doi.org/10.1016/S0140-6736(09)60715-7
Morgan H, Thomson G, Crossland N, Dykes F, Hoddinott P, BIBS study team. Combining PPI with qualitative research to engage “harder-to-reach” populations: service user groups as co-applicants on a platform study for a trial. Res Involvement & Engagement, 2016, 2(7) doi:10.1186/s40900-016-0023-1 pmid:29062508
Competing interests: No competing interests
Some may be interested in my longer articles on the paradigm of patient. Apologies, I should have included these in my first RR.
"The paradigm of patient must evolve: Why a false sense of limited capacity can subvert all attempts at patient involvement," Patient Experience Journal: Vol. 4 : Iss. 2 , Article 2. Available at: http://pxjournal.org/journal/vol4/iss2/2
"The engaged patient is an anomaly. Let’s fix the paradigm." Engaging Patients blog, April 2017. http://www.engagingpatients.org/shifting-the-paradigm/engaged-patient-an...
"Beyond Empowerment: Patients, Paradigms, and Social Movements" - Patient Safety & Quality Healthcare, April 2016 (cover story) https://www.psqh.com/analysis/beyond-empowerment-patients-paradigms-and-...
Competing interests: No competing interests
Clarifying the roles in any partnership is very important, whether it be in a multi-disciplinary research team or patient, public or practitioner engagement. I commend the authors for bringing this important issue forward. The article, however, seems to set ethical research up as something that is difficult to do in partnership situations. When patients’ contributions as partners are taken seriously, ethical research must be partnership research. Partnerships should make research more ethical, not less so.
The article suggests that when patients contribute as partners their contributions cannot also be analysed as data: “To do so would circumvent ethical approval and result in poorly conducted, unethical research”. There are, however, strong qualitative research traditions in other areas that engage both practitioners and public (e.g., nursing, education, social work) that have well-developed frameworks for conducting participatory research. This can include a) research co-design where partners design studies and collect data and analyse with researchers and b) action research where partners are simultaneously researchers and part of the data. There are of course careful negotiations of roles, boundaries and consent but to say that this is impossible is to ignore that it is already being done in valuable, ethical and rigorous ways in other fields.
The article seems to also over-emphasize only one element of ethical research. In describing the possibility that partners might contribute to pilot data and the analysis of that data, they argue “There are ethical challenges to these practices, however, such as how to maintain anonymity of participants in the research report once they become active partners.” It is important for everyone to be aware of ethical implications of their participation in any aspect of research but there are ethical principles beyond protection of anonymity that must be considered. For example, the Canadian Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans [1] is explicitly guided by three principles: Respect for Persons (including autonomy of research participants and partners), Concern for Welfare, and Justice. It explicitly outlines that in some kinds of research, especially where contributions are made beyond providing data, respect for the participants’ contribution should be shown by identifying them for those contributions or offering them the choice to be identified. Respecting autonomy and providing justice for communities that have been historically been harmed by unethical research, as the authors rightly argue that patients have been, can mean respecting their ability to choose whether their contributions are anonymous or named and recognized.
I thank the authors for bringing attention to the importance of thinking carefully about patients’ roles in research but suggest that this must go further to recognize that including patients as partners is not a challenge to ethical research but an essential element of it.
1. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, December 2014.
Competing interests: No competing interests
> “Common misunderstandings are a barrier to real progress”
Well said. In human discourse, meaning depends on context, and when social roles are evolving, such misunderstandings can have the full force of a head-on collision. How many times have we seen Party A state something (perhaps with the best intentions) and Party B respond, “That’s madness!” The exchange can lead to anger: “Don’t tell me you didn’t mean it that way – I know what you said!”
And that’s not to mention the clashes as perspectives shift from passive to active. Even within the patient movement anger can erupt if one party says s/he wants to shift from “passive patient” to “empowered consumer” while another activist considers “consumer” to be a pawn of the industrial economy.
> an unhelpful diversity of terms [engagement, participation, involvement]
Our “paradigm of patient” is at a breaking point. In his landmark 1962 book Structure of Scientific Revolutions (the book that brought “paradigm” into popular usage) Thomas Kuhn wrote that scientific fields have predictable stages, and that the pre-paradigm stage is characterised by the lack of agreement about fundamental principles – a stage in which practitioners literally cannot talk to each other.
Aside from those words for engagement (whose meanings overlap but are not identical), we have multiple conceptions of how to understand observations of a patient’s role or how to intervene: Hibbard’s Patient Activation Model [“PAM”], Prochaska’s TTM (trans-theoretical model), Miller & Rollnick’s motivational interviewing, etc. And that’s not to mention Angela Coulter’s The Autonomous Patient, a concept unimaginable to the benighted, though she wrote it sixteen years ago.
The most egregious example I’ve seen of this “model blindness” was the February 2013 issue of the US policy journal Health Affairs, titled “New Era of Patient Engagement.” Its articles contained at least three different implied definitions of engagement, yet not a soul noticed. No wonder we haven’t made much progress and people talk at cross purposes.
And lacking an agreed (and evidence-based) model, it’s no wonder that people keep creating policies and practices that treat patients as passive recipients. Besides, it gets so messy when policies have to respond to diversity of patient wants and aptitudes.
But Kuhn also wrote, “Discovery commences with the awareness of anomaly, i.e., with the recognition that nature has somehow violated the paradigm-induced expectations that govern normal science.” Indeed, today we constantly see examples of engaged, empowered, informed, thinking patients altering the outcomes of their cases, which makes it patently obvious that Liabo is right in saying the term “patient” no longer denotes a passive recipient of healthcare.
It can be no clearer: every time a clinician, researcher, administrator or government policy agent imagines patients as passive recipients, s/he is not only out of touch with evolved reality but is thus actively holding back progress. We the patients object.
Competing interests: No competing interests
I am afraid I could not disagree more with this. It reflects a UK-centric view of patient and public involvement which takes as given the NIHR definitions as well as current ethics committee approaches. It is perfectly possible for patients/the public to be both active collaborators and providers of data, and this approach has deep roots in the action research and community-based participatory research traditions. That our current UK ethical procedures struggle with these approaches is true, but the solution lies not in making artificial distinctions but reforming our approaches to ethics. We need to move beyond an approach that equates ethical behaviour with consent, and return to a deeper consideration of potential benefits and harms, and consider carefully how society as a whole might benefit from research in which engaged community members are both researchers and researched.
Competing interests: No competing interests
Re: Clarifying the roles of patients in research
I have been active in PPI for twenty years and have seen many examples of how a lay input to the planning and delivery of healthcare can provide visible, often measurable, improvement. PPI in research – which I define to exclude the necessary involvement of patients as data sources, is a more recent development. In societal terms, PPI in designing and pursuing research is arguably a welcome example of “transparency” but since it is supported by resources that could be used otherwise it is valid to ask: is it worth it?
The relevant literature is nearly all anecdotal and/or qualitative – accounts of small numbers of case studies. There have been two larger surveys (BMC Health Services Research 2014, 14:89 and HS&DR 3:38, September 2015) but the only discoverable quantitative paper was in BJPsych 2013, reporting a positive correlation between level of patient involvement and success in trial recruitment in a batch of 374 studies in the area of mental health.
The present situation was summed up by a “closed study evaluation” published by NIHR CRN in January 2015:
“…growth of PPI is paralleled by unease at the paucity of evidence for its impact.”
My proposal is to seek a link between perceived quality of research and extent and quality of PPI. The data set would be proposals considered by any funding source. Quality is taken to be the result of considering the proposal – typically the mark awarded by funding committee following peer review. (In NIHR bodies, this is on a 10-point scale with the result recorded to one place of decimals; I have been told that other funders use a similar approach.) This data exists, requiring only the collaboration of the funder to make it available. The challenge comes with designing a measure for the PPI, since a linear scale does not really suffice as a descriptor for such a varied phenomenon: this will need trial-and-error, to find a system that works well enough on a sample of research proposals. The whole population of projects then need to be ranked against the chosen system and here, a consensual approach using more than one inspector could be appropriate. There then remains the simple task of seeing what the relationship is between funding marks and PPI marks.
The link being sought is one that I think I have noticed to occur. This is a subjective and selective view, very possibly influenced by how enjoyable the experience has been. We really do need a harder-nosed look at it. I hope that someone can be encouraged to take this up and if it comes to fruition I hope the project will itself include PPI. None of the reports mentioned above were moderated in this way, which seems to me a very strange thing.
John Walsh
July 2018
Competing interests: No competing interests