The concept of empowerment has deep roots in various social movements that sought to challenge systemic inequalities and give voice to marginalized groups. To analyze how these conceptual approaches to empowerment from social movements relate to the empowerment of patients in PPI within clinical research, we will first provide an overview of the historical development of PPI in research, followed by a recall of the relevance of empowerment in the context of PPI. We will then analyze and critically address (a) the similarities of approaches to empower patients or the public in PPI as compared with other fields, and by that get an impression how PPI in clinical research can empower patients, and (b) the distinctions and limitations of empowerment in this context, both practically and conceptually.
Evolution of PPI in research
Patient advocacy movements, gaining momentum in the mid-20th century, played a pivotal role in pushing for increased patient involvement in research [33]. These movements, which often emerged from broader social and civil rights movements, laid the foundation for what we now recognize as PPI.
For instance, the HIV-AIDS activism of the 1980s, heavily influenced by the gay civil rights movement, led to significant changes in health research by challenging the prevalent research expertise and bringing in “a ´patient perspective` to bear on institutions of health research” [34].
In the 1970s, Rose Kushner, a breast cancer patient and writer, exemplified this movement by assessing research proposals for the US National Cancer Institute, marking a notable instance of patient influence [33]. Her efforts reflected a broader movement towards giving patients a voice in research, a theme that is echoed in many PPI initiatives. The 1980s collaboration between patient organizations and the Association for Maternity Services, endorsing a randomized controlled trial on chorionic villus sampling, is another example where patient involvement began to influence research decisions directly. The 1997 international breast cancer advocacy conference organized by the US National Breast Cancer Association (NBCC) and supported by patient organizations from several countries marked a pivotal shift towards PPI, fostering dialogue on patient experiences and challenges. The conference demonstrated the NBCC’s belief that breast cancer patients should be consulted when making policies and decisions regarding research funding, and was instrumental in establishing an international advocacy movement [35].
The connection between PPI and social movements became more explicit with the establishment of organizations like INVOLVE in 1996, funded by the British government as part of their aim to create a patient-oriented healthcare system, the Canadian Institutes for Health Research in 2000, and the Patient-Centered Outcomes Research Institute (PCORI) in the United States in 2010. These organizations, drawing inspiration from social movements, emphasize the importance of involving patients and the public throughout the research process, thereby continuing the advocacy for marginalized voices in health research [36,37,38].
Globally, there is a trend toward formalized PPI approaches. Research funders, regulatory bodies, and institutions recognize the importance of involving patients and the public throughout the research process, from prioritization to dissemination [1, 2]. At current there is still a lot of development and movement in the process.
Relevance of empowerment in PPI
As discussed, there are two arguments advocating for PPI use in research, that Ives et al. summarize [3]: (1) to improve research quality, appropriateness, relevance, and credibility (PPI as a means to an end) and (2) to use PPI to empower patients and democratize research along with its consequential impact on health(care) (PPI as an end in itself). However, empowerment through PPI should not be seen as an isolated goal, and Ives et al. phrasing as “an end in itself” might be misleading and be better put as “an end beyond narrowly instrumental goals”. PPI is a strategy that allows patients to actively shape research, thereby ensuring that the research directly addresses the practical problems they face – an argument rooted in the social movements.
PPI is essential in transforming the relationship between patients and institutions, challenging traditional power dynamics [34]. Its role is dual-faceted: it improves the quality and relevance of research while simultaneously fostering a more participatory and inclusive approach to healthcare. This dual function makes PPI a powerful tool for achieving both immediate research goals and broader societal change.
However, depending on the reasons and initiators of PPI, PPI practices can vary greatly. According to Ives et al. [3], different aims of PPI can result in distinct forms of involvement, as illustrated in Table 1. While Ives et al. [3] seem to indicate two opposite ends of the spectrum, these “ideals” do not always play out and there are numerous intermediate forms of involvement that can exist. However, this example illustrates that the potential for empowerment in PPI, as well as its manifestations, can vary greatly depending on the approach taken.
Today PPI spans a broad range, from sporadic consultations, to ongoing collaboration between patients and researchers, and even (still rare examples of) research led by patients with support from researchers [39].
Similarity of empowerment in PPI in clinical research to earlier concepts
In the following sections we analyze and critically address the similarities and limits of empowerment in PPI in clinical research as compared with earlier concepts. Similarities of empowerment in PPI in clinical research to earlier concepts seem to be in a focus on participation, challenging power structures, valuing diverse knowledge and perspectives, and supporting collaboration.
Emphasis on participation
Active participation in decision-making processes that influence the lives of individuals and communities is a fundamental aspect of empowerment concepts across various fields [24]. In research-based PPI, facilitating the ability of patients and members of the public to have a voice, participate in decision-making processes, and contribute to research aligns with the core principles of empowerment.
Challenging power structures
Empowerment theories from different disciplines aim to reduce powerlessness and increase the power of marginalized individuals [25, 28, 29]. The objective of challenging power structures aligns with the concept of empowerment in PPI in research. Involving patients in planning, conducting, and communicating clinical research on a regular basis constitutes a significant shift in the power dynamics of the research landscape. Individual patients may be engaged on a one-time basis, but the collective voice of patients and the public becomes significant and co-determines research. Long-term patient involvement may be achieved through the integration of patient advisory boards in research institutions [40]. The inclusion of patient perspectives has become an expected practice, influencing power dynamics within the clinical research domain.
Recognition of diverse knowledge and perspectives
Empowerment in various fields recognizes the worth of diverse knowledge and perspectives [26, 28, 32]. By incorporating them, empowerment aims to challenge the conventional power structures that have systemically marginalized some voices and sustained inequality. Moreover, involving individuals with varied experiences offers exceptional insights and understandings that enhance dialogues and contribute to more thorough resolutions [28]. Similarly, patient experiential knowledge and unique insights are recognized as crucial in PPI for shaping research and complementing the specialist knowledge of clinical researchers [4, 13]. According to the Montreal Model, patients’ experiences with illnesses, which they must manage for the rest of their lives if chronically, offer a rich source of knowledge essential for decision-making [41]. This experiential knowledge includes patients’ insights into their health issues, the trajectory of their care, and the impacts on their personal lives and those of their loved ones [41]. The involvement of patients strengthens the focus of clinical research on patients’ needs, ultimately enhancing its quality, adequacy, relevance, and credibility [3, 4].
Collaborative relationship
Empowerment approaches typically foster collaborative relationships among various stakeholders [19, 28]. In social work, these relationships arise between the practitioner and the client and are characterized, analogous to the idea of an alliance, by a “shared sense of urgency” (regarding the client’s problems), a “conjoint commitment to problem solving in as democratic a manner as possible”, and a “shared emphasis [.] on [the] common humanity” in the relationship [19]. Depending on the PPI approach, the concept of collaborative relationships among various stakeholders can also apply to empowering patients in research. Three involvement approaches in PPI are distinguished [6]: (1) The consultation approach achieves the lowest level of engagement and collaborative relationships, wherein patients provide advice to researchers but are not involved in decision-making. (2) Patients are partners in the research process in the collaboration approach, with their involvement in decision making and shared responsibility for the research. (3) Patients in user-led research take full responsibility for individual aspects or the whole research, with support from researchers [6]. User-led research can only be implemented to a limited extent in clinical studies, as it is subject to ethical and legal framework conditions.
To strengthen the principles of social movements in PPI, a collective approach to research, as proposed by MacDonald’s theory of civic patienthood, could provide valuable insights [34]. This theory views patients as civic actors who seek collective solutions to collective problems, shifting the understanding of patients from merely clinical subjects to engaged participants in shaping research and healthcare outcomes. This approach needs robust institutions, resources, and socialization processes to support patients’ involvement. It is particularly critical in ensuring that PPI remains genuinely democratic and is not co-opted by more powerful interests [34].
Distinctions of empowerment in PPI in clinical research to earlier concepts
While we found the heritage of social movements to inform the ethos of PPI in the principles of participation, giving people a say in decisions that affect their lives, confronting power structures—albeit on a smaller scale—, and collaborative relationships, we also found distinctions of empowerment in PPI in clinical research to earlier concepts. These seem to be in the areas of context and focus, scientific demands and ethics, expertise in research methods, and power dynamics.
Context and focus
While the goals of empowerment in other fields and PPI share similarities, there are differences in the context and focus. In social movements, empowerment refers to the process through which marginalized individuals and communities obtain power, active participation, and the ability to challenge oppressive systems [18, 29]. These movements often aim to effect systemic changes and combat inequalities, drawing upon collective action, raising awareness, and advocacy to achieve their goals [29, 30]. In contrast, the context of empowerment in PPI is more specific to the research process. Here, empowerment is about providing patients and the public with a voice in decision-making within that process [4]. While the influence of social movements is undeniable, the primary objective is not necessarily to address systemic inequalities on a broad scale but to enhance the quality and relevance of research by incorporating diverse perspectives. In PPI, people are empowered or given a voice “to influence research outcomes that will (or may) have a direct impact on their health status“ [6]. Though not the main objective, this involvement of diverse perspectives in research may nonetheless potentially contribute to a reduction in inequalities [42, 43].
However, the practical implementation of PPI often faces challenges that may undermine its empowering potential. Researchers, under pressure to demonstrate measurable impact, tend to focus the conduct of involvement on substantive values such as effectiveness, quality, and validity – outcomes that are more easily quantified and aligned with traditional research goals [4, 14]. This focus may lead to the marginalization of crucial but less easily measured normative values like empowerment, rights and accountability and process values such as partnership or respect. The demand for measurable outcomes and recommendations for the conduct of PPI that lead to rather structured and controlled PPI mechanisms shape PPI practices in ways that may suppress rather than amplify the voices of patients [14]. A more reflexive and dialogic approach to evaluating PPI might better capture its ethical and formative dimensions, ensuring that public involvement in research remains a tool for true empowerment rather than an instrument of containment [14].
Scientific demands and ethics
Empowerment in clinical research must balance patient empowerment with scientific demands and the integrity of research findings. Empowerment approaches in other fields may concentrate on personal growth and social change. However, in clinical research there is a need to find ways that respect both the methodological and ethical requirements of research and the interests of PPI. This aspect, which is specific to this context, distinguishes it from empowerment in other fields and may restrict the potential for empowerment in clinical research as well as put specific demands on the conduct of research [17, 44]. As a result, the level of patient co-determination may be limited. For example, for methodological reasons randomization might be preferable, even if alternative methods are perceived as more appropriate by the patients involved for understandable reasons. Additionally, patients may lack a full understanding of these restrictions, causing them to suggest ideas that do not comply with the logic of scientific protocols. This encounter with limitations during interactions with scientists can potentially diminish their level of empowerment.
In addition to methodological hurdles, PPI must address ethical considerations in the pursuit of empowerment. Although it is generally assumed that patient involvement does not necessitate an ethics vote, it is nonetheless crucial to discuss with potentially involved parties regarding matters such as safeguarding their privacy and potential conflict of interests, and to furnish them with comprehensive information about the involvement’s goals and methodology [45]. The framing of the involvement, and therefore the empowerment, in this manner distinguishes it from empowerment in other fields.
Expertise in research methods
Empowering patients in research requires providing objective support and resources to enhance their comprehension of research methods and ethics [17]. Usually, patients need assistance in navigating the complexities of research processes and methodologies [17, 46], which distinguishes empowerment in PPI from other fields. However, learning is a common aspect in any kind of empowerment. For instance, Freire’s theory of critical consciousness highlights education’s role in empowering marginalized individuals [30]. His approach centers on learners directing their own education by posing questions and emphasizes skill development over knowledge acquisition with a focus on increasing critical awareness of their circumstances.
The disparity in PPI may stem from individuals, who desire and deserve empowerment, not being the ones to decide what to learn, but from the fact that this choice is often made for them and is very factual. In terms of preparation for PPI, the learning is mostly unidirectional, whereby the researchers instruct the patients on research fundamentals [47]. However, there is a mismatch between the perception of training needs between researchers and PPI contributors (i.e. patients), both in terms of training for PPI contributors and researchers. Dudley et al. [47] found that this discrepancy leads to gaps in the support and training provided. That said, the characterization of unidirectional learning does not apply universally. For example, some PPI initiatives have employed more interactive and participatory training methods, allowing patients to engage more actively in shaping their learning experience [48].
Providing PPI support and training enables patients to acquire the necessary knowledge and skills to work alongside researchers on an equal basis, and to furnish patients with the confidence they need to challenge researchers opinions when needed [49]. Importantly, expertise in clinical research methods is not only a means of achieving empowerment but also a crucial component of enhancing the quality and relevance of research. By developing expertise, patients can contribute more meaningfully to the research process, ensuring that their perspectives and experiences are integrated in ways that improve research outcomes.
To strengthen empowerment in PPI and reduce vulnerability to co-optation by more powerful forces with different problem-solving interests, it is critical that participants have a clear understanding of the power they seek to build [34]. MacDonald’s theory of civic patienthood illustrates that socialization is central to helping patients understand their agency, role, and limitations as civic actors in PPI [34]. The design of this process can significantly impact how power and empowerment are navigated within PPI.
Power dynamics
Self-determination of the client is an essential aspect of empowerment practice in social work, and it is commonly believed that empowerment cannot be imposed upon anyone else [29]. In this regard, professionals are responsible for providing support and facilitation and it is crucial to minimize power differentials between all parties involved in order to foster relationships based on equality and partnership [29].
In research-based PPI, addressing power asymmetries between researchers and patients is critical. Researchers typically operate with institutions that have structures and established norms, facing constraints and pressures imposed by their institutions which can influence the extent of shared-decision making and the balance of power. Often, researchers have the final say in decisions [6]. These dynamics of institutional power can lead to challenges in achieving equal partnerships.
To navigate these constraints effectively, it is crucial to understand the extent to which patients are involved in the research process, how their roles are negotiated with researchers, and the level of their involvement in decision-making. Researchers must balance their own institutional limitations and the robustness of the research with the need to foster patient empowerment. This process can be challenging and at times frustrating. Promoting patient empowerment in clinical research impacts organizational processes, cultures and public relationships, requiring frameworks that recognize, address and integrate patient perspectives into research activities [49].
link