Public involvement (UK health initiative)

Public involvement in UK health and care research is the last active remnant of the National Health Service Reform and Health Care Professions Act 2002 (Part 1, Section 5).[2] The Act set up a Commission for Patient and Public Involvement in Health with a remit to move towards lay people's involvement in all aspects of health and care. The Commission had no funding, however, and closed in 2008. The Commission was replaced with a structure of 151 'Local involvement networks'; these had good funding and much the same aims - but were themselves abolished in 2013, as noted in the wiki article just linked.

The UK's major funder of health and care research is the state-funded National Institute for Health Research (NIHR) - the research arm of the National Health Service. There are corresponding but subordinate organisations in Northern Ireland[3], Wales[4] and Scotland[5] (all accessed 15 May 2020).

NIHR claims to “[involve] patients and the public in all our work”.[6] In the context of public involvement, however, as important is an offshoot of NIHR called 'INVOLVE', set up in 1996 and separated from NIHR in 2020. One of the aims of this advisory body is “to support active public involvement in NHS, public health and social care research”.[7]

A number of key British medical bodies, such as the National Institute for Health and Care Excellence (NICE)[8] and Medical Research Council,[9] have adopted formal policies for public involvement.

The mention of the UK's National Health Service has led to uncertainty whether or not there need be public involvement other than in state-funded health and care research. However, by 2020, a number of privately funded studies had started to have PI, some co-funded with NIHR and some with a charity. By 2017 most charities involved in UK health and care research had active public involvement staff and committees, with hundreds or even thousands of PI volunteers. For instance, Parkinson's UK says "Everything we do [in research] is driven by people affected by Parkinson's."[10] The larger charities in particular have increasing interest in public involvement with commercial research.

Even so, as yet (2020) there is meaningful (and, therefore, effective) public involvement in only a small proportion of health and care research. That's mainly because, however much good will there may be, PI is still very new and uncoordinated, and any organisation wanting to take it on properly needs a large number of volunteers, as implied above.

Other relevant public sector health / care research organisations in the UK are:

• The regulatory Health Research Authority (HRA), whose home page[11] says "we involve patients and the public in [our] work to improve health research design, delivery and regulation."
• The Medical Research Council (MRC), which has an Ethics regulation and public involvement committee.[12]

Also, despite NIHR’s example and INVOLVE’s support, there are many different models of public involvement in health and care research. Increasingly, public involvement in research is expected and even demanded by those funding it. However, as yet (2020), not all funders even ask researchers applying for support to say what PI they've had and how much they plan. Effective PI is anticipated at all stages, from initial twinkles in researchers' eyes to the final dissemination of outcomes.[13]

The involvement triangle

Members of the public can have a role in health / care research in three broad levels. (This classification[17] follows the eight-rung ladder of citizen participation.[18])

• Participation - the most common level, where research happens one-way on or to people (eg as patients or controls). Participation in research appears as the broad base of the triangle shown. This is because most people with a role in health or care research are participants.
• Engagement - where researchers communicate and describe their work to the public. This can happen in many ways. For instance, if research is not yet complete, a research team may describe their thinking, progress and interim findings. If research is complete, the team may report to a public audience or disseminate findings by press release. Even plays have been put on to explain serious medical issues to lay audiences.[19]
• Involvement - where members of the public have an active role and close contact with the research team. INVOLVE says “public involvement in research [is] research being carried out ‘with’ or ‘by’ members of the public rather than ‘to’, ‘about’ or ‘for’ them.”[20]

There may be hundreds of volunteers in an involvement group or network, with several central full-time staff and / or volunteers working to make them an effective team. For instance, the Alzheimer's Society Research Network (founded over twenty years ago, in 1999) has several hundred volunteer members and two staff facilitators; the website[21] lists some fifteen roles for the PI members. The Society spends over £10 million a year on funding research; the Network costs perhaps a quarter of a million pounds a year (though there is some commercial sponsorship)

Despite the increased demand for public involvement in health and care research, concerns have been expressed at the variable quality of feedback coming from that involvement. In 2017 new guidance was provided in an attempt to address this issue.[22][23] At around the same time, NIHR published the first draft of the PI standards mentioned at the start of this article.

One of the six standards concerns getting to know the impact of public involvement: "To drive improvement, we capture and share the difference that public involvement makes to research." (That is from the 2018 version; the final, 2019, version is somewhat less clear: "Seek improvement by identifying and sharing the difference that public involvement makes to research.") Ref 20 above has much to say about this - impact is coming to be an important aspect of PI reporting.

Impact relates to PI effectiveness (quality) of course. Indeed, it can lead to cost-effectiveness, important as PI can cost as much as 10% of some research budgets. Knowledge of PI impact has several levels -

• recognising that PI makes a positive difference in specific ways;
• assessing the difference caused by PI (mainly qualitatively, but in some cases semi-quantitatively);
• measuring the difference so we can indeed get a grip on the effectiveness of PI in a given context.

Of course, it's not possible actually to "measure" PI impact, ie the difference it makes. This is because it is not possible to compare a study with PI with exactly the same study without. PI impact "capture" covers just levels 1 and 2 above; however, it is still important.

An overview of the subject of PI impact came from UK's Alzheimer's Society at the start of 2018.[24]

Apart from cost, there are few reasons why all stages of health and care research should not involve the public. NIHR’s PPI Framework 2015-2018 states: “We ensure that processes are in place to involve the public in all stages of the research we fund and manage … guaranteeing the involvement of patients, carers and members of the public at all points in the research process.”[25] In any event, effective PI can lead to more effective research and that should save money, much by cutting waste. (This includes the huge cost of failed research and studies not completed.)

Broadly speaking, research – of any kind, not just for health or care – is problem-solving. Once a problem is precisely defined, solving it uses the problem-solving cycle. The research cycle shown is the same as that. (Scientific method has much more detail.)

Research = problem-solving

Needs analysis (or problem analysis) is that first stage of defining precisely the problem to be researched: the research question. The next stage – which can take months – is to define precisely the apparently best and most appropriate solution: the research method. Only after this can the research team apply for funding.

Implementation is the main part of the cycle – carrying out the research and analysing the results. This may take a couple of years.

When that is over, the research team should evaluate the outcomes. This means checking with care that they have solved the problem, ie answered the research question asked. There can be many reasons for failing at this stage. In scientific research (science) and inventing (technology), the people concerned go round and round the cycle until they succeed. In other words, they return to needs analysis to tweak the research question, then to solution analysis to tweak the research method, and so on. One of the problems with much of health and care research is that the study runs out of funded time so evaluation can be hasty, and re-cycling is left out. The team leaves the cycle top left and goes on to the stages of reporting and disseminating. Or not, if the study failed to meet its objectives (or even came up with the "wrong" answers). There are many causes of research failure....

Main types of PI activity

One of the benefits of public involvement is to help the research team understand lay people's needs and perspectives and ensure that research is relevant and acceptable to them[26]. This can reduce the chance of failure and make the research more effective and more cost-effective.

A recent study of Parkinson's UK public involvement[27] made those points clearly.

• University College London Hospitals: How patients have helped us with our research
• National Standards for Public Involvement in Research website