ReviewPublic involvement at the design stage of primary health research: A narrative review of case examples
Introduction
The active involvement of the public in health and social research is central to the research policy agenda of the UK and other western nations [1], [2], [3]. In the UK, for example, the Department of Health states that a key feature of a quality research culture in the National Health Service (NHS) is research, “pursued with the active involvement of service users and carers including, where appropriate, those from hard to reach groups such as homeless people” [3]. Many of the major research funding programmes in the UK, such as Research for Patient Benefit, require researchers to demonstrate how patients and members of the public have been involved in the design of the proposal, and how they will be involved in the research if funding is successfully awarded [4]. Across England, the National Institute for Health Research has established Research Design Services to help researchers engage with clinicians and members of the public to design proposals for submission to national funding competitions for applied health or social care research [5]. This paper presents a detailed review of published cases of public involvement in research design, to synthesise the contributions that members of the public have made to research design, and to discuss the tensions and facilitating strategies that have been identified.
It is important at the outset to be clear about what we mean by ‘the public’ and by ‘involvement’ in the context of health research. In the UK, the term ‘public’ is said to include: patients and potential patients; people who use health and social services; informal carers; parents/guardians; disabled people; members of the public who are potential recipients of health promotion programmes, public health programmes and social service interventions; and organisations that represent people who use services [6]. Public involvement in research has been defined as doing research ‘with’ or ‘by’ the public, rather than ‘to’, ‘about’ or ‘for’ the public [6]. Three main levels of public involvement have been identified [7]: these are (1) consultation (where researchers seek the views of patients and members of the public on key aspects of the research); (2) collaboration (an on-going partnership between researchers and the public throughout the research process); (3) ‘user-control’ (where the public designs and undertakes the research and where researchers are only invited to participate at the invitation of the public).
Aside from the policy imperative, three main arguments have been put forward in support of public involvement in health research. Firstly, there is an epistemological argument relating to the knowledge and experiential insights that patients and members of the public can bring to research. Beresford, for example, argues that, “the shorter the distance between direct experience and interpretation (for example as can be offered by user involvement in research), then the less distorted, inaccurate and damaging resulting knowledge can be” [8]. This argument poses an epistemological challenge to positivistic views of enquiry within health research, which state that knowledge can be collected ‘at a distance’ from participants who are treated solely as passive suppliers of data [7]; for, as Beresford argues, “if non-service users do seek to undertake research and interpret service users’ knowledge and experience, then they must seek to get closer to it” [8]. Perhaps this epistemological argument is best encapsulated by the famous words (and oft-repeated campaigning slogan of advocates of public involvement): “nothing about us without us” [9].
The second argument in favour of public involvement is expressed in terms of morals, ethics and rights. In the UK, the public, as tax-payers, are part-owners of the NHS and contributors to publicly funded research. A strong case can be made therefore that the public should be actively involved in any publicly funded research which may impact on their health status or the functioning of the NHS [10]. Public involvement is also a means of empowering minority and disadvantaged groups in society [7], [8], and the appropriateness of methodologies that in some way empower those actively involved in the research have been carefully considered [11], [12], [13].
Thirdly, there is an effectiveness or consequentialist argument that states that public involvement has the potential to improve the quality, relevance and impact of health research [7], [10]. Previous authors have written on the positive contribution that patients and members of the public can bring to research by suggesting relevant research questions and outcomes, ensuring that consent forms and information sheets are user-friendly, and assisting with the recruitment of participants, data collection, data interpretation, and dissemination [7], [14], [15].
The literature on public involvement in research has grown considerably in recent years, with researchers focusing attention on public involvement in different subject areas within health (e.g. nursing, midwifery and health visiting [16], complementary therapy [17]); different population groups (e.g. older people [18], people with learning difficulties [19], people with cancer [20]); different research methods (e.g. clinical trials [21]); and different stages of the research process (e.g. prioritisation [22], interpretation [23]).
One of the most important stages of the research process for members of the public to be involved in is that of research design, because they have the opportunity at this stage to maximise their influence and impact [24]. At the research design stage, the public have the opportunity to ensure that the research question is relevant to their needs and experiences; relevant outcomes and outcome measures are addressed in the proposal; data collection instruments reflect issues that they want to see addressed; issues pertaining to participant recruitment, information provided to participants and consent procedures are thought through; and consideration is given to the level and extent of public involvement in the study assuming it is successfully funded.
The aim of this paper therefore is to review published case examples of public involvement in primary research design, in order to synthesise the reported barriers, facilitating strategies and impacts of involving the public at this critical stage in the health research process. It is hoped that this synthesis will provide evidence-based guidance to researchers and members of the public involved in primary research design activities, and would complement the guidance documents provided in the UK by INVOLVE on public involvement in developing research grant applications [25], [26], [27].
Section snippets
Definition of terms and scope
The review used as a guide INVOLVE's definition of public involvement in research: doing research ‘with’ or ‘by’ the public, rather than ‘to’, ‘about’ or ‘for’ the public [6]. The review aimed to identify detailed published cases of public involvement in research design and the development of applications for funding for primary research. By ‘primary research’, we mean research that involves the collection of new data: this contrasts with secondary research, such as systematic reviews, that
Findings
On the basis of a review of titles and abstracts, eight papers were initially identified for this review. However, one paper was excluded on acquisition because it reported on a pilot study (i.e. formal data collection) to inform the design of a trial, and thus did not explicitly address public involvement in research design [28].
Discussion
This review has identified a number of international examples of public involvement in primary health research design on a variety of health research topics. Four key contributions that members of the public made to research design were identified: review of consent procedures and patient information sheets; suggestion of outcomes; review of acceptability of data collection procedures; and recommendations on the timing of potential participants into the study and the timing of follow-up.
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