Patient engagement is defined as “The active, meaningful, and collaborative interaction between patients and researchers across all stages of the research process, where research decision-making is guided by patients’ contributions as partners, recognizing their specific experiences, values, and expertise” (Harrington et al., 2020). This can include patients, other relevant stakeholders like family members, and formal and informal healthcare providers (Carman et al., 2013). Patients and Stakeholders Engagement (PSE) can provide a unique perspective, sometimes with firsthand knowledge and experience that is more relevant and approachable to the needs of patients and stakeholders. (Hickam et al., n.d.)(Watson et al., n.d.)(Shippee et al., 2015). Community-based participatory research (CBPR) studies indicate that patient participation in research is essential for reaching unreachable or otherwise underserved patients. (De et al., 2007)(Washington et al., n.d.).Numerous authors assert that research participation is crucial for empowering patients in their healthcare through self-empowerment, enhanced self-confidence, a sense of being respected, an effect on their mental health, the desire to contribute, and a desire to serve the community (citizenship literacy) (Nsangi et al., 2020)(J. M. Brett et al., 2014) (J. Brett et al., 2010). Researchers also claim that by engaging patients and caregivers early in the research process, they can effectively serve as early ambassadors of research efforts and additional findings, potentially broadening audiences beyond peer-reviewed journals and facilitating the acceptance and implementation of results in the community and healthcare setting. (Saunders et al., 2007)(Abma et al., 2009). Politically speaking, the majority of patients and researchers concurred that patient participation in the study process boosted credibility, which helps democratic ideals of accountability, transparency, and legitimacy in public and private organizations (Shippee et al., 2015)(Concannon et al., 2012). The eminent quote 'nothing about us, without us' emphasized that researchers would have a moral obligation to engage patients in research beyond the role of subjects(Us & 1998, n.d.). As a result, patients and other stakeholders have a basic right to participate in the research process and should have the chance to influence its direction. (Vat et al., 2021).
Although there are currently a large number of papers describing PSE activities and several models and recommendations with a wide range of quality and varied focuses, there is still a lack of consensus throughout the studies, on how to best build and foster PSE (Greenhalgh et al., 2019) (Fergusson et al., 2018)(Price et al., 2018). The gaps include an absence of understanding of how to engage a broad range of stakeholders across the healthcare system; which methods, models, and strategies of PSE are practicable throughout the earlier and later phases of research; how the opinions of stakeholders are synthesized and used to form research design, implementation, and dissemination; and how to collaborate with stakeholders to increase intervention effects, decrease disparities, and/or sustain tested interventions (Concannon et al., 2014). According to Esmail and her colleagues, research generally did not make explicit their aims for PSE to establish a cohesive, generalizable evidence base that enables comparability across studies and countries. While technique measurements of engagement were emphasized more than results, there is still a need to understand who should be engaged, when, and how. According to their studies, PSE has to develop more conceptual direction and consensus to guide evaluation processes (Esmail et al., 2015). Workman proposed developing measurable effect indicators and procedures in addition to those focusing on changes in the attitudes and degrees of satisfaction of research participants. (Workman et al., 2013).
Stroke is the world's second leading cause of mortality and lifelong disability (Krishnamurthi et al., 2017). The aged population in Europe is expected to grow by 35% between 2017 and 2050, resulting in an increase in stroke survivors due to an aging population and increasing survival rates(Wafa et al., 2020). Twenty to fifty percent of persons may have at least one of these challenges, such as post-stroke depression (PSD), anxiety, vascular cognitive impairment (VCI), and post-stroke fatigue (PSF), which can delay recovery and result in poor functional results and reduced quality of life (Cumming et al., 2016). However, acute treatment and prevention methods have improved over the last several decades, and the incidence of stroke continues to fall at a constant rate in Oxfordshire and other high-income countries, even though the total number of stroke incidents in aging populations is increasing(Li et al., 2020).
Fortunately, there is overwhelming evidence that stroke is mostly preventable, curable, and manageable, with the potential to greatly lessen the burden of stroke and its long-term consequences. Nonetheless, all parties, including government agencies, scientific and stroke support groups, healthcare professionals, clinical and preclinical researchers, patients, and their families, must work together to achieve this (Norrving et al., 2018). The study by McKevitt and colleagues showed a lack of European understanding of stroke research. According to the European Stroke Action Plan for 2018 to 2030, researchers, healthcare professionals, and patient groups must enhance how research results are related to patient populations and study participants (Mckevitt et al., 2015).(Norrving et al., 2018) (Norrving et al., 2018).
Stroke patients present unique challenges to PSE, emphasizing the need for a disease-specific approach: many survivors are elderly, and they frequently have severe disabilities, including speech problems, making participation in PSE activities difficult, as opposed to, say, cancer or other similar diseases. As a result, we believe that specific prerequisites are required for successful and meaningful PSE in this field of study. Furthermore, the perspective of relatives and caregivers may be even more important than in other diseases because they bear a major fraction of the patient's burden, but from a very different perspective. Patients' and related stakeholders' involvement at the start of the clinical development process can significantly improve study design and delivery. It not only allows for a better understanding of the patient's needs, but it also allows for protocols to be considered in real-life scenarios, issues to be identified, and problems to be resolved before a study opens for enrollment. As a result of better study design, participant recruitment, retention, and protocol adherence, PSE can improve the relevance and quality of research projects.
To our knowledge, no systematic literature reviews have been conducted to describe how patient engegment has been approached and assessed in stroke research. However, there is a protocol that sounds similar to the title of our study but differs in content (Hall et al., 2022). The two investigations have different objectives. Hall and colleagues' review identifies and describes patient and public involvement (PPI) activities, study types, and PPI participants in published stroke research, whereas our protocol presents a thorough scoping review of Stroke Patient and Stakeholder Engagement (SPSE) concepts, definitions, models, implementation strategies, indicators, or frameworks. Both of these studies produced their protocol at different times. Furthermore, in the Hall study, data will be extracted using Joanna Briggs Institute protocols, with results collated and matched to the research cycle stage/s, but we will use Arksey and O'Malley's six stages.
As a result, our preliminary findings reveal a lack of scientific evidence to involve all stakeholders in research on treatment and rehabilitation for this growing and vulnerable patient population. The concept of interest is thus to identify the types of evidence associated with SPSE, the extraction of experiences and recommendations, the clarification of key concepts, definitions, and components, and the identification of models, implementation strategies, indicators, or frameworks for establishing an SPSE. This protocol describes a systematic scoping review of Stroke Patient and Stakeholder Engagement (SPSE), concepts, definitions, models, implementation strategies, indicators, or frameworks at the Charité on QUEST Center for Responsible Research and the NeuroCure Clinical Research Center (NCRC) at the Berlin Institute of Health (BIH).