Posted by Douglas Badenoch on April 27, 2026

The James Lind Library announces a new section on Patient and Public Involvement and Engagement (PPIE) — and we need your help to build it.

In 1811, the novelist Fanny Burney underwent surgery for breast cancer — without anaesthetic. She survived, and she wrote about it.

Her account, sent in a letter to her sister Esther, is one of the most vivid and harrowing descriptions of the patient experience ever committed to paper. She described the terror, the pain, the powerlessness. What she could not have known was that, two centuries later, patients like her would not merely endure medical decisions — they would help shape them.

The James Lind Library (JLL) has spent over two decades documenting how we came to test treatments fairly — through controlled trials, systematic reviews, and evidence-based practice. But so far we have neglected a fundamental aspect: the story of how patients and the public became active participants in research, not just its subjects.

A neglected history

The involvement of patients in shaping health research is not a recent invention dreamed up by funding bodies. It has deep roots. What is new is the formal recognition that it can lead to better, more relevant science.

Consider the HIV/AIDS crisis of the 1980s. When government and the medical establishment moved too slowly, patients organised. ACT UP (the AIDS Coalition to Unleash Power), founded in 1988, did not just march in the streets — members educated themselves in virology and pharmacology, demanded places at the table in clinical trial design, and fundamentally altered the pace and shape of AIDS research. The Terrence Higgins Trust in the UK played a similar role, working in partnership with the Medical Research Council to show how patient communities could become genuine research collaborators.

A decade later, women with breast cancer were doing the same, with the Lancet’s conference on breast cancer in Brugge in 1994 highlighting the growing importance of patient involvement in decision-making about breast cancer research. That year also saw the establishment of the Consumers Advisory Group for Clinical Trials, chaired by Hazel Thornton.

By the late 1990s, advocates had joined the MRC’s breast cancer trial design processes. In 1999, the MRC established its Consumer Liaison Group, acknowledging formally what campaigners had already demonstrated in practice: the people most affected by a disease have something essential to contribute to the research that addresses it. As one participant in those discussions put it, patients had ‘substantial practical knowledge of their condition’ — knowledge that no clinical expert possessed.

In rheumatology, OMERACT (Outcome Measures in Rheumatology) was pioneering a different model: bringing patients and clinicians together to agree which outcomes actually mattered in clinical trials. If a trial measures the wrong things — things that matter to doctors but not to patients — then even a perfectly designed study can give the wrong answers. OMERACT showed that patients could help ensure the right questions were being asked.

These were precisely the arguments Vikki Entwistle and colleagues had made in a landmark 1998 BMJ article — one of the earliest and most influential arguments for involving lay people in health research as a matter of course.  They argued that patients bring practical knowledge of their condition, a clearer sense of which outcomes matter, and perspectives on values and priorities that clinicians simply cannot supply on their behalf.

In the UK, INVOLVE played a central role in establishing the importance of public involvement in research. It began, in 1996, as the Standing Advisory Group for Consumer Involvement in the Research and Development Programme for the NHS.  It became part of the National Institute for Health Research (NIHR) the following decade, before being replaced by the NIHR Centre for Engagement and Dissemination in 2020. The two-decade timeline for these, and other activities that developed and implemented good practice for PPIE in clinical research in the UK was recently mapped out by Bec Hanley and colleagues.

PPIE has come a long way, in what feels like a short time (to us – Frances Burney might have a different perspective). Has it come the right way? What impact has it had, and where can it be improved?

Why the JLL is adding a new section on PPIE

The James Lind Library’s mission is to illuminate how fair tests of treatments have developed over centuries. Patient and public involvement is one of the most significant methodological advances of recent decades — yet it has no home in our taxonomy. That is an omission we intend to put right.

Section 4 of the JLL will now address PPIE. It will sit alongside our existing sections on systematic reviews, research reporting, and the use of evidence — because PPIE is not a soft ‘add-on’ to research methodology. It is a fundamental part of how we decide what to study, how to study it, and how to ensure the results are used. We will explore topics including patient activism and advocacy, priority-setting, co-production, patient-reported outcomes, the ethics of involvement, and the challenge of ensuring diverse voices are heard.

We also want to be honest about complexity. Patient involvement, done badly, can introduce bias or be co-opted by vested interests — as the campaign for wider access to Herceptin demonstrated, when genuine patient need became entangled with commercial pressures. Our new section will reflect the full picture, including critical perspectives on how PPIE is practised.

We need your help

We cannot build this section alone — and we should not try. The whole point of PPIE is that knowledge is distributed. The history of patient involvement in research is held by the people who lived it: advocates, researchers, patients, carers, and communities around the world.

So we are asking for your help. Do you know of a historical example — however modest — of patients influencing the design, conduct, or interpretation of research? A campaign, a collaboration, a moment when a patient’s voice changed the direction of a study? We want to know. These are exactly the kinds of records and primary sources the JLL was built to preserve.

We are also inviting researchers, historians, patient advocates, and PPIE practitioners to contribute articles and essays to the JLL website and to the Journal of the Royal Society of Medicine. We are particularly interested in:

• Historical case studies of patient activism and its impact on research
• The evolution of PPIE terminology and what it reveals about changing power relationships
• International and comparative perspectives — PPIE looks very different in the UK, Canada, Rwanda, and Sweden
• Critical reflections on the limits and risks of patient involvement
• The role of creative and community-based approaches in making research participation more inclusive.

If Fanny Burney’s letter — written in memory of pain and terror the year after her surgery — can tell us something important about the patient experience, then the minutes of a breast cancer advocacy meeting in 1994, or an early report of an ACT UP protest, can do the same.

History is made of such things. Help us collect them.

Get in touch or share this post with anyone who has a story to tell.

References and further reading

Burney F (1812). [Letter to Esther Burney, Dated 22 March 1812, pp8-11]. Literature in Context: An Open Anthology of Literature in English, 1400-1925.  University of Virginia.

Frances Burney.  Wikipedia.

Entwistle VA, Renfrew MJ, Yearley S et al (1998). Lay perspectives: advantages for health research. BMJ 316(7129):463–6.

Evans I (1994). The challenge of breast cancer. Lancet 343: 1085-1086.

Thornton H (1998). Alliance between medical profession and consumers already exists in breast cancer. BMJ 316: 148.

de Wit MP, Abma TA, Koelewijn-van Loon MS et al (2014). What has been the effect on trial outcome assessments of a decade of patient participation in OMERACT? Journal of Rheumatology 41(1): 177-184.

de Wit M, Kirwan JR, Tugwell P et al (2017). Successful Stepwise Development of Patient Research Partnership: 14 Years’ Experience of Actions and Consequences in Outcome Measures in Rheumatology (OMERACT). Patient 10(2): 141-152.

Denegri S, Evans D, Palm M & Staniszewska S (2024). The History of INVOLVE: A Witness Seminar.

Palm ME, Evans D, Staniszewska S et al (2024).  Public involvement in UK health and care research 1995–2020: reflections from a witness seminar.  Research Involvement and Engagement 10 (65).

Lynn-Gordon J, Bernard S, Warren B et al (2010). Consumers United for Evidence-based Healthcare (CUE): Development of a consumer advocacy coalition in the United States. Poster, Cochrane Colloquium.

Stewart DC. A history of patient involvement (particularly in cancer research). Making the Difference blog.

Domecq JP, Prutsky G, Elraiya T et al (2014). Patient engagement in research: a systematic review. BMC Health Services Research 14 (89).

OMERACT: Outcome Measures in Rheumatology. https://omeract.org

Burney portrait:  By Edward Francis Burney, public domain.