Protocol for a scoping review of patient engagement in pharmacy practice research

Abstract

Introduction

Over the last 20 years, the pharmacist’s role in healthcare has evolved, moving towards patient-centred care, collaboration and medication therapy management. Patient engagement in research is similarly being recognised as a transformative approach to healthcare due to its positive impact on outcomes and research relevance. However, patient engagement in pharmacy practice research is nascent. Therefore, we present a protocol for a scoping review to map the current state of patient engagement in pharmacy practice research, identifying its extent, range, nature, barriers, facilitators, impacts and gaps.

Methods and analysis

This protocol was developed in collaboration with persons with lived experience (PWLE). The scoping review will be conducted using established methodological frameworks and guided by the Best Practice Guidance and Reporting Items for the Development of Scoping Review Protocols and the Guidance for Reporting Involvement of Patients and the Public (GRIPP2) checklists. A comprehensive search involving three large databases, Medline (Ovid; 1946–Present), Embase (Ovid; 1974–Present) and Scopus (Elsevier), grey literature sources, forward and backward reference checking and consultation will be completed to retrieve the relevant literature. We will include published and unpublished research related to pharmacy practice that adopts patient engagement in research approach. Full-text screening will occur to determine eligibility for inclusion. Data will then be charted using a comprehensive extraction form. Qualitative data will be synthesised using basic qualitative content analysis, and quantitative data will be analysed using descriptive statistics. Regular meetings with PWLE and the research team will guide data analysis, interpretation and dissemination.

Ethics and dissemination

Ethics approval was not required for this protocol as we did not collect participant data. Findings may be disseminated through peer-reviewed publications, conference presentations, social media and knowledge user meetings, as informed by the perspectives of PWLE. Knowledge gained from this review will inform the development of strategies that support patient engagement, advance pharmacy practice research and have the potential to improve health outcomes and patient experiences.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• A systematic, comprehensive search of multiple databases and grey literature will be performed, increasing the likelihood of capturing relevant studies on patient engagement in pharmacy practice research.

• Persons with lived experience were engaged throughout protocol development and will be engaged in the review, grounding the research in lived experiences and perspectives.

• Clear and inclusive definitions of key concepts such as ‘pharmacy practice research’ and ‘patient engagement’ within our review will facilitate consistent data extraction and enhance the study’s relevance.

• Variability and inconsistency in the definition of ‘pharmacy practice research’ and the reporting of patient engagement in the literature could lead to challenges in identifying and categorising relevant studies.

Introduction

Patient engagement has emerged as a pivotal approach in healthcare practice and research, with growing recognition of its positive impact on outcomes of care and research quality.¹,⁶ Within the scope of pharmacy practice, patient engagement has become increasingly relevant with the evolution of the pharmacist’s role in patient-centred care, medication management and disease prevention.⁷ The extent to which this evolution in practice has effectively translated into meaningful changes in patient experience in different regions and settings is unclear. Further, despite the emphasis on patient-centric approaches in pharmacy practice, there remains a notable gap in the literature on using patient engagement within the area of pharmacy practice research.

Patient engagement in research involves meaningful and active relationships between academic researchers and patients (here, referred to as persons with lived experience (PWLE)). The term ‘PWLE’ is inclusive of individuals with experience of a health issue, including care partners (eg, caregivers such as family members or friends).^{8 9} Although specific definitions vary, patient engagement may also be referred to as patient and public involvement, patient involvement and consumer and community involvement in research. While there is no set definition of what actually constitute ‘meaningful’ and ‘active’ relationships, key features may include inclusivity, adequate support, mutual respect, cobuilding, two-way communication and the opportunity to achieve desired impacts on the research process and its outcomes.^{9 10} The extent to which an engagement opportunity embodies two-way communication and shared decision-making is typically conceptualised using the spectrum of engagement.^{11 12} PWLE can engage throughout the research system, including areas such as governance, priority setting and development of research questions and methodologies.^{9 13} They bring unique perspectives through lived/living experiences, and are guided by their other experiences, values, expertise and preferences.^{8 10 14} This departure from conventional academic researcher–participant relationships into a more inclusive, collaborative partnership has been shown to improve efficacy, quality and impacts of research and patient care.¹,³⁵

Despite the acknowledged benefits of incorporating patient engagement into research planning and implementation, a 2017 scoping review of patient engagement in pharmacy practice research revealed a scarcity of literature, identifying only two relevant articles.¹⁵ This review underscored issues such as lack of uptake in pharmacy research, inconsistencies in reporting and lack of clearly defined approaches (eg, practices, models and theories) to engage patients in research.¹⁵ Another article by Cantarero-Arevalo et al¹⁶ proposed 24 tips for engaging patients in social pharmacy research based on a rapid review of engagement models, frameworks, guidelines and a case study of four Nordic initiatives. However, the results of engagement in the search were beyond the purview of their commentary; thus, details around the extent and context of engagement within this area were not discussed.

Rationale

Engaging PWLE helps ensure that research is relevant, meaningful, effective and appropriate.¹,³ Its application to pharmacy practice research requires further exploration, not only to advance academic undertaking of this approach, but to inform the refinement of research, policy, education and practice in pharmacy. To address this need, an understanding of current practices and applications of patient engagement in pharmacy practice will provide a foundation for recommendations that guide future research in this field.

Objective

The objective of this paper is to present a protocol for a scoping review that maps the current state of patient engagement in pharmacy practice research. It will help identify the extent, range and nature of patient engagement in pharmacy practice research, including current barriers, facilitators, impacts and gaps. Through this work, we intend to offer insights for PWLEs, academic researchers, faculty, students, practitioners and policymakers on how to support and implement patient engagement in pharmacy practice research. The implications of these insights in research, health and healthcare outcomes were also explored.

Methods and analysis

We have chosen to undertake a scoping review as we are seeking to provide a broad overview of the state of patient engagement in pharmacy practice research.¹⁷,¹⁹ Consequently, as is standard practice for scoping reviews, we do not propose to assess the methodological quality of the included literature.¹⁷,¹⁹ This protocol’s reporting was guided by the Best Practice Guidance and Reporting Items for the Development of Scoping Review Protocols, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Extension for Scoping Reviews (PRISMA-ScR) and the Guidance for Reporting Involvement of Patients and the Public (GRIPP2) checklist.²⁰,²²

Overview of scoping review methodology

As expanded below, the scoping review’s design and conduct will be guided by the iterative framework originally developed by Arksey and O’Malley¹⁹ and further refined by Levac et al²³ and Joanna Briggs Institute.^{20 24}

Stage 1: identifying the research question

The proposed scoping review sets out to map the state of patient engagement in pharmacy practice research. Using the population, concept and context framework (figure 1), the following research questions were developed in alignment with this objective:

Figure 1. Research question key concepts as defined by the population, concept and context (PCC) framework. The PCC framework was used to define parameters of the research question and associated search strategy. It explores the intersection between patient engagement and pharmacy practice research, illustrating the key components guiding the investigation.

1. How were PWLE identified for engagement in pharmacy practice research?

2. Through what approaches (eg, engagement levels, activities and processes) did PWLE engage in pharmacy practice research and how were these decided on (eg, by academic researchers or in partnership)⁸ and evaluated?

3. What were the facilitators to patient engagement in pharmacy practice research and how were these identified and evaluated?

4. What were the challenges to patient engagement in pharmacy practice research and how were these identified and evaluated?

5. What were the reported impacts of patient engagement in pharmacy practice research and how were these identified and evaluated?

Stage 2: identifying relevant studies

Search strategy

We worked with an academic librarian (CM) to develop a search strategy that incorporated the key concepts identified in Step 1 (see table 1 for a sample search strategy), adapted from previous reviews.^{25 26} This search strategy was validated by a second academic librarian using the Peer Review of Electronic Search Strategy checklist.²⁷ An academic librarian will run the search strategy in Medline (Ovid; 1946–present), Embase (Ovid; 1974–present) and Scopus (Elsevier) using a combination of controlled vocabulary and keywords. These databases were chosen due to their scope and relevance to the topic. No filters or limits will be used in the search. To locate the grey literature, the librarian will use similar search terms in Google, preprint repositories and various websites related to pharmacy practice and patient engagement. Further, we will conduct forward (ie, a check to see which studies have cited the included literature) and backward (ie, check the reference list of the included literature) reference searches. Finally, we will consult professional and social networks (eg, LinkedIn, X) and subject matter experts to identify additional literature. All references will be exported directly to Covidence (Veritas Health Innovation, Melbourne, Australia) for deduplication and screening.²⁸

Table 1. Sample search strategy for Ovid Medline, 1946–present.

Database: Ovid MEDLINE(R) Epub Ahead of Print and In-Process, In-Data-Review & Other Non-Indexed Citations and DailyPlatform: OvidDate Searched: November 25, 2024Number of results: 852
#	Searches
1	pharmacy/ or evidence-based pharmacy practice/ or pharmacies/ or pharmacists/ or Pharmaceutical Services/or community pharmacy services/
2	(pharmacy*2 or pharmacies? or pharmacist*2 or pharmacoepidemiolog*).tw,kf.
3	or/1–2 [Pharmacy]
4	Community Participation/ or Stakeholder participation/
5	Cooperative Behavior/
6	((patient* or consumer* or public? or layperson* or layman* or laymen* or famil* or care-giver* or caregiver* or parent* or carer? or spous* or stakeholder* or outpatient*) adj3 (participat* or involv* or engag* or empower*)).tw,kf.
7	(patient* adj2 (researcher* or research or partner* or collaborat*)).tw,kf.
8	or/4–7 [Patient Participation]
9	Pharmacy Research/ or Pharmaceutical Research/ or Health Services Research/
10	practice-based research.tw,kf.
11	Translational Medical Research/
12	research.ti.
13	((study or trial*1 or research*) adj2 design*).tw,kf. or Research Design/or User-Centered Design/
14	((knowledge or research) adj2 (disseminat* or translat*)).tw,kf.
15	or/9–14 [Research]
16	3 and 8 and 15
17	Patient Participation/
18	“patient and public involvement”.tw,kf.
19	(co-research* or coresearch* or codesign*).tw,kf.
20	((participatory or user-cent*) adj2 (research* or design*)).tw,kf.
21	Community-Based Participatory Research/
22	(expert patient or patient expert).tw,kf.
23	or/17–22 [Patient Researcher]
24	3 and 23
25	16 or 24

Eligibility criteria

The scoping review’s inclusion and exclusion criteria are presented in figure 2. Given the often-absent reporting of patient engagement in research in abstracts, we deemed that a full-text review of all the identified literature was necessary to determine the presence of patient engagement in research. Consequently, we chose to focus on one specific subtype of pharmacy research to manage the workload associated with this screening approach. As our team’s mutual interests lie in the patient-facing aspects of pharmacy research, we chose to focus on pharmacy practice research. This decision reflects the expanding role of pharmacists and the potential impact on patient experiences and outcomes. Finally, as the intention of scoping reviews is to provide a broad overview of the existing literature on a topic, we chose to include the published and unpublished literature of actual or proposed engagement activities and did not include any limitations specific to publication date. However, due to limited resources, non-English publications will be excluded from the review.

Figure 2. Eligibility criteria. Inclusion and exclusion criteria are outlined, involving descriptions of article type, study type, population, concept and context. Criteria were designed to capture a comprehensive understanding of patient engagement in pharmacy practice research, emphasising both rigour and relevance to the research objectives.

Stage 3: study selection (screening)

Based on our research team members’ previous experience screening articles for patient engagement in research,²⁹ we plan to screen the full texts of all the identified literature for inclusion into the review. Based on available resources, a minimum of two reviewers will be involved in screening the literature for inclusion. Each full-text article will be independently screened by two reviewers, and any discrepancies will be resolved through discussion and consulting a third reviewer if necessary. To pilot test the screening process, 20 articles will be independently screened by reviewers, and determination of eligibility will be compared. Reviewers will also meet after screening approximately 10% of the identified literature to discuss any ambiguities and refine the eligibility criteria as needed. Changes to the eligibility criteria will only be made after discussion with the entire research team and will be clearly documented and reported in the scoping review publication. Covidence will be used to manage the study selection process.

Stage 4: charting (data extraction)

One reviewer will extract data from included literature using a standardised data abstraction form developed by the study team. Table 2 displays a list of the variables we propose to extract, as informed by our previous work^{5 29 30} and discussions with our research team. A second reviewer will check the extracted data for accuracy. Any discrepancies will be resolved through discussion and consulting with a third reviewer if necessary. The standardised data abstraction form will be trialled on a randomly chosen subset of three studies to ensure that it is gathering information relevant to the research question.¹⁸ Changes will be discussed and agreed on with the full research team and will be clearly documented and reported in the scoping review publication.

Table 2. Variables to be charted.

Category	Variable
Publication characteristics	Title
	Publication year
	Journal (or source if unpublished)
Author characteristics	Surnames
	Countries
	Are any of the authors also the study’s persons with lived experience (PWLE) (if so, how many)?
Study characteristics	Aim(s)
	Design
	Setting (eg, hospital, community)
	Intervention characteristics (if applicable)
	Type of pharmacy practice research
	Outcomes (primary and secondary)
Engagement characteristics	What was the stated purpose of engaging PWLE in the research?
	How were potential PWLE identified/recruited by the research team?
	What were PWLE’s roles/responsibilities in the research? How were these decided on?
	What was the level of engagement based on the revised International Association for Public Participation (IAP2 Spectrum of Engagement11 and how did you determine this (eg, stated in the article—do you agree; if unstated and based on your perceptions—please explain your reasoning)?How was the level of engagement decided on and evaluated by the study’s research team? Report any findings of the evaluation.
	What were the processes used to make study decisions/reach consensus? How were these decided on?
	What were the activities used to engage patient partners, by stage of the research cycle? How were these decided on and evaluated? Report any findings of the evaluation.
	What processes were used to support PWLE in partnering to their desired potential? How were these decided on and evaluated? Report any findings of the evaluation.
	What were the facilitators (investigated and/or reported—please specify) for engaging PWLE in the research? How were these identified and evaluated?
	What were the challenges (investigated and/or reported—please specify) for engaging PWLE in the research? How were these identified and evaluated?
	What were the impacts of engaging patients in the research? How were these identified and evaluated?
	How were PWLE compensated and/or reimbursed for engagement?
	What guidelines were used to guide the reporting of patient engagement in the study?
	Provide any other information that you feel is relevant to note about this study’s engagement approach (eg, was capacity building provided to the team? Was cocreation used? Were cultural safety and/or trauma-informed approaches used? Was there a guiding model or framework for the engagement?).

Stage 5: collating, summarising and reporting the results

We will report on the counts of literature identified and selected for inclusion in the scoping review using a PRISMA flow diagram for the scoping review process.²⁰ This will be accompanied by a narrative description of the screening decision process.¹⁸ Our analysis approach will be finalised once we have finished charting data from all included studies. However, we anticipate that we will use content analysis to analyse qualitative data, as recommended by Pollock et al for the analysis of scoping review results³¹ and guided by the three-step approach outlined by Elo and Kygäs.³² We will use an inductive approach, as we anticipate fragmented and incomplete knowledge and reporting of patient engagement in research based on previous literature.^{15 16 32} Thus, once data extraction is completed, we will begin with open coding and observing common themes, which will inform the development of a coding framework in collaboration with PWLE.^{31 32} Data will then be organised into categories within this framework to address the objectives of the review and highlight key themes and ideas.^{31 32} We will use descriptive statistics to summarise quantitative data. For example, we may calculate means (SD) or medians (25th and 75th percentiles) for continuous data and counts (frequencies) for categorical data. We will likely create a summary figure of the overall findings and also present data using supporting tables, figures and/or concept maps. We will hold regular meetings with PWLE and other members of the research team to guide data analysis, interpretation and synthesis of findings. During this stage, included literature may be excluded from the scoping review if it does not provide sufficient data to address at least one of the review’s underlying research questions.

Patient and public (PWLE) involvement

Protocol development

Four PWLE (JG, JK, JM and TS) were engaged in this protocol’s development. The aim of patient engagement in this research was inherent in relation to the research topic, ensuring the research questions, process and outcomes were aligned with PWLE needs and priorities. PWLE were recruited through a variety of social media platforms (eg, X, LinkedIn), using the engagement opportunity description found in online supplemental file 1. To be eligible to engage in the study, PWLE were required to have reliable access to a computer or smart device, the internet, as well as the ability to attend team meetings and review study documents. It was also preferred that patient partners had prior experience engaging in pharmacy research and could meet virtually during regular working hours. PWLE were compensated $C25/hour for their contributions to this research. In terms of the spectrum of engagement,^{11 12} PWLE collaborated to revise the protocol initially developed by the rest of the research team. This means that they ‘partnered on equal footing’ with the rest of the research team, including sharing in the decision-making by openly sharing their preferences and opinions and working through mutually agreed upon alternatives and terminology. Earlier involvement of PWLEs in the formation of the research idea and planning did not occur due to trouble recruiting patient partners locally. At the outset of the partnership, PWLE met with the first and senior authors (JV and AMC) to codevelop terms of reference. This document detailed their mutual intentions for engagement, roles and expectations, desired impacts and characteristics of the partnership that will support meaningful and active engagement throughout the development of the protocol and conduct of the scoping review. In developing the terms of reference, they also identified ways in which they wanted to contribute to protocol development and scoping review conduct. Protocol development activities entailed providing written feedback, which PWLE further discussed and revised with the first and senior authors through three virtual, 2-hour meetings. A summary of PWLE’s impact on the protocol is provided in figure 3.

Figure 3. Summary of persons with lived experiences’ (PWLEs) impacts on the scoping review protocol. The impacts of PWLE on scope and rationale, terminology, research methodology, references and overall conduct of the research are described, influencing the research to better align with patient needs and experiences.

Scoping review conduct

All four PWLE (JG, JK, JM and TS) plan to continue to collaborate on the conduct of the scoping review. If more than one PWLE is no longer able to engage in the scoping review, we will endeavour to recruit more PWLE using the same methods as for the scoping review protocol. Due to budgetary considerations necessary to support engagement at the level of ‘collaborate’, which is generally considered a moderate level of engagement, our targeted number of PWLE will remain at 3–4.¹¹ PWLE will continue to contribute to shared decision-making through written and verbal input, including meeting regularly (approximately every 2–4 weeks) across the stages of the scoping review. Although budgetary constraints prevent PWLE from helping to screen literature or extract data, they will have opportunities to take part in ‘mini exercises’ that allow them to gain first-hand experience with these stages in a small subset of literature. We will evaluate the engagement process using the Public and Patient Engagement Evaluation Tool³³ and group discussions occurring at major study milestones and focus on exploring experiences with engagement and suggestions for refinement. PWLE will continue to be compensated $C25/hour for engaging in the scoping review and contribute as coauthors to any resultant publications if they satisfy International Committee of Medical Journal Editors guidelines.³⁴

Strengths and limitations

This paper outlines a protocol for an extensive exploration of patient engagement in pharmacy practice research. Given the lack of robust literature characterising the application of patient engagement within pharmacy practice research, a vital opportunity exists to describe the methods, determinants and impacts of this approach within the context of pharmacy practice research. The current state of research in this area is marked by limitations in both methodological rigour and scope, which we aim to address in the review.^{16 35} This will be accomplished through the inclusion of multiple databases and grey literature, as well as full-text screening rather than title and abstract screening for eligibility to ensure the appropriate inclusion of relevant articles. This procedure facilitates a more comprehensive process to map current literature and will build on the existing literature in the field.

A notable challenge in this review is the inconsistencies in standard nomenclature for pharmacy practice research.³⁶ Currently, pharmacy practice research appears to be broadly conceived, as there are variable and inconsistent conceptualisations in the literature.^{35 37 38} Within the scope of this review, pharmacy practice research is defined as any research activities pertaining to pharmacy practice or patient care, where the population is pharmacists in a practice setting (eg, community, hospital) or the intervention and/or control is being delivered by a pharmacist in a practice setting. This includes, but is not limited to, clinical and outcome research, health services research and comparative effectiveness research. This definition was informed by a scan of both scientific and grey literature focused on pharmacy practice research.³⁵³⁷,⁴⁰ By operationalising this definition, a broader spectrum of research activities within the field of pharmacy practice may be included to improve relevance and appropriateness of the findings.

Ethics and dissemination

This protocol describes the scoping review methodology for a critical examination of literature conceptualising patient engagement in pharmacy practice research. Ethical approval was not sought, as the research pertains to secondary analysis and does not involve the collection of participant data. The systematic assessment of the utilisation and reporting of engagement in pharmacy practice research may have important implications for practical guidance in meaningfully engaging patients in future research. Knowledge gained from this scoping review may be used to develop learning infrastructure for positive, meaningful and effective engagement, laying the groundwork for enhancing patient-centric care and the advancement of pharmacy practice research.