Engaging patients in anesthesiology research: a rewarding frontier

Patient-oriented research in anesthesiology

Patient-oriented research is an emerging approach that engages patients, clinicians, and researchers to ensure focus on patient-identified priorities.¹ From a clinical perspective, involving patients in medical decisions is required by law and professional code (i.e., informed consent). Informed consent requires evidence that is pertinent to the decision at hand, but also information that is deemed relevant by the decision maker (the patient). Despite the importance of research in providing evidence to inform such clinical decisions, engaging patients in clinical research is not frequently done, is often suboptimal, and is not required by regulations and good practice. The failure to engage patients in clinical research has led to large swathes of research that neither addresses patient priorities nor collects data on outcomes that are meaningful to patients and their families.

This paradox is highly relevant to the field of perioperative research. Indeed, the low quantity and quality of the involvement of interested parties in perioperative care guidelines development, including the incorporation of patient preferences, was identified as a methodological weakness in North American and European guidelines for anesthesiologists.²

Internationally, patient-oriented anesthesia research is gaining traction with large pragmatic trials such as REGAIN³ that evaluate effectiveness based on patient-centred outcome assessment (in this particular study, the effect of general vs spinal anesthesia on death or inability to walk ten feet independently following repair of hip fracture). Nevertheless, documented examples of patient-oriented research in anesthesia remain few and far between. Results from a systematic review showed that the prevalence of patient engagement in interventional research is very low with less than 1% of published trials having meaningfully involved patients.⁴ In Canada, priorities in patient-oriented anesthesia research were recently determined with a James Lind Alliance process by the Canadian Anesthesia Research Priority Setting Partnership.⁵ The Canadian Anesthesiologists’ Society, the Canadian Perioperative Anesthesia Clinical Trials Group,¹ and others supported a multidisciplinary panel (inclusive of patients and caregivers) to generate a top-ten list of patient-oriented research priorities. This important initiative is intended to act as a roadmap to guide Canadian patient-oriented research in anesthesia and perioperative medicine.

Our team has taken up this call to action by developing a research program to identify intraoperative pharmacologic opioid minimization strategies that could alter patient-centred outcomes after surgery. To identify and assess these strategies, we are first conducting a scoping review that will inform planned surveys, systematic reviews, and ultimately a pragmatic randomized controlled trial (RCT) of an opioid-minimizing intervention. Our program addresses three important priorities from the Canadian Anesthesia Research Priority Setting Partnership, namely the impact of reducing opioids during anesthesia, pain control after surgery, and long-term side effects of anesthesia after surgery.⁵ To ensure that our review is relevant to adult patients undergoing general anesthesia and who might be receiving opioids, we made an early decision to partner with patients to collaborate and co-create our scoping review. In an effort to promote this approach and provide a Canadian example of patient engagement in anesthesiology research, we describe our efforts to integrate “patient engagement” in the research process (i.e., meaningfully and actively collaborate with patients as partners).

Patient engagement in health care research

Patient engagement is an important component of quality and relevance in health care research.^6,7,8 While we use the term patient engagement here, terms such as patient consultation, patient and public involvement, or public participation, may be used synonymously. The terms used locally may vary depending on jurisdiction and in some cases the same terms may have different meanings.^{1, 9} We chose to define our work based on the Canadian Institutes of Health Research (CIHR) taxonomy as our project was developed in Canada.¹⁰ The CIHR defines patient engagement as “an approach where patient partners can potentially contribute to every stage of the research process, including governance, priority setting, and conduct of research. They can also summarize, distribute, share, and apply its resulting knowledge (i.e., the process known as knowledge translation and exchange).”¹⁰ Importantly, research is conducted with patients as true partners in the process, and the research is not done “to” or “for” them specifically. As such, patient engagement in research ultimately aims to increase the relevance and applicability of the research to patients, caregivers, and families. Growing evidence indicates that patient engagement can help refine research questions and protocols, improve recruitment in clinical trials by making research more patient-centric, and facilitate shared decision-making at the patient’s bedside by providing applicable and relevant evidence.^{11, 12} Moreover, the ethical and moral imperative for involving patients in research is clear as patients are the ultimate users of health care research; they are the beneficiaries of clinical care.¹³

How can we apply patient engagement to anesthesiology research?

As an exemplar, we engaged with patient partners in the preliminary phase of designing our research program (e.g., a scoping review to inform next phases of the program). Based on the World Health Organization toolkit for stakeholder analysis, patients were identified as a key interested party for our initiative,^14,15 so we sought to form a panel of patient partners to join our investigative team.¹⁶ We, as a group of researchers and patient partners, designed a patient-oriented scoping review to describe the current evidence from RCTs assessing the effectiveness of intraoperative opioid minimization strategies.

Our approach to identifying patient partners leveraged our institutional infrastructure that facilitated the matching of patient partners with research teams¹⁷ using an advertisement distributed through our hospital’s Patient and Family Engagement Program (PFEP), which involves > 200 patients who have volunteered to serve as advisors for clinical processes, policy decisions, and/or research. The advertisement included information regarding the proposed study area, ideal experience (lived experience of surgery and general anesthesia), and anticipated commitments. Four patient advisors consequently expressed an interest in partnering on the project and the PFEP lead organized an introductory meeting between the patient advisors and the research team. Following an initial meeting to explain the project and discuss the likely time requirements, we invited all four patients with lived perioperative experience to join us as patient partners and all agreed. Working with the patient partners, we codeveloped a formal engagement strategy and a terms-of-reference document (available at the Open Science Framework [OSF] from URL: https://osf.io/afm3z/ [accessed February 2023]). This discussion, and the resulting document, included methods of compensation, acknowledgement, authorship, training, and support for patient partners and researchers, as well as approaches to evaluate the patient engagement activities.^{1, 18} In developing our process, we explicitly considered how we would implement the guiding principles set out by the CIHR Strategy for Patient-Oriented Research (SPOR) framework¹⁹ while also addressing barriers frequently encountered in clinical research. Solutions were developed based on the context of perioperative medicine as well as locally available support and resources.¹⁷ The SPOR principles, identified barriers, and implemented solutions are outlined in Table 1.^{20,21,22,23,24}

Table 1 Strategies to facilitate patient engagement tailored to perioperative research¹⁹

We chose the SPOR partnership-focused approach¹⁹ as this “principle-based framework” is designed to optimize collaborative partnerships between researchers and patients or organizations.²⁵ By focusing on a principle-based approach, we were able to adapt our processes to the specific context of our study, as opposed to being tied to specific methods or practical approaches. In keeping with some engagement principles, we have built strong and sustainable relationships (over a one-year period) through transparency (mutual goals agreed on), commitment, respect, regular communication and feedback (email updates, group discussions), and ongoing evaluation. This type of approach was facilitated by our institution and through the Ontario SPOR Support Unit, of which our organization (Ottawa Hospital Research Institute) is an active member through the Ottawa Methods Centre. Our institutional structure is called the “Ottawa model.”¹⁷ This model provides useful guidance on developing infrastructure and facilitating patient engagement in research. This structure also allowed us to have methodological support. For example, each meeting with the patient partners is co-led by a patient-oriented research facilitator who is affiliated with the SPOR Support Unit.²⁰ Based on the CIHR’s Spectrum of Citizen Engagement (e.g., five levels of participation, namely: communications, listening, consulting, engaging, and partnering), the levels of patient engagement in our research project met the criteria of consulting, engaging, and partnering depending on the phases of research.²⁶ Of note, patient engagement is often described as a continuum; as a result, labeling and description of each level can vary depending on jurisdiction and country.²⁷

The patient partners’ perspective on engagement benefits

As patient partners, we had either very different or limited experiences with patient engagement in research, so our expectations for the opioid minimization in surgery project, were extremely open. As patient partners, we felt we were an integral part of the team and we brought our lived experiences, which informed not only how we saw the research question but also what information or data were most relevant to us. To date, we have provided input into the review through discussions and written comments, including assessment of the relevance of the scope of the review, the outcomes, the plain language abstract, the planned items for extraction, and the revision of grant applications, and have helped to plan the dissemination phase. More specifically, we helped shape how and which patient-centred outcomes would be accounted for in the review through group discussions, assessment of certain scales and instruments, and revision of the literature. We also assessed the perioperative patient-centred outcomes consensus proposed by the Standardised Endpoints in Perioperative Medicine international initiative (i.e., the StEP-COMPAC group) to ensure they were adequately relevant, comprehensive, and applicable to our context.²⁸ Through this process, we challenged some measures suggested by the StEP-COMPAC. For example, we decided that the lack of endpoints to assess chronic pain following surgery was an important omission.

We appreciated the openness and inclusion of our views and preferences received from researchers and having ample opportunity for collaborative discussion. We were a diverse team in terms of age, hospital exposure, treatment, and opioid-related experiences: we all came from different circumstances, and feel we were listened to from the beginning, with the same respect, regardless of our professional, patient, or ongoing family interaction with hospital services and protocol. We now know what a scoping review is, what stages are involved in such a review and some of the challenges. Hence, we were able to provide relevant insights, ideas, and judgements throughout the process. We also learned what anaesthetic options are used in general surgery along with their variations in practice. We appreciated being invited to join the project early, as we believe that our various and unique lived experiences helped the research team foster the question to better answer our community needs and be aligned with the end-user priorities. We appreciated the patience and camaraderie of the researchers and clinicians, as this helped us to feel like genuine colleagues and a legitimate part of the team. Perhaps most importantly, we know that we are helping improve quality of care through patient-oriented research.

The importance of evaluating patient engagement

Evaluating patient engagement is a necessary step to ensuring meaningful collaboration (i.e., one that is not tokenistic). Evaluation not only strengthens the patient partnership process but can also help uncover facilitators and challenges that arise during the execution phase of the research study.

To achieve meaningful and active collaboration with patient partners, our team codeveloped an improvement-oriented evaluation plan (i.e., developmental evaluation aiming at improving the process of engagement within the project) following the CIHR Guide to Evaluation in Health Research.²⁹ As a part of this approach, we chose to assess the satisfaction of patient partners. To help us identify the most relevant tool, we used the Centre of Excellence on Partnership with Patients and the Public Engagement Assessment Toolkit. This toolkit is a decision aid informed by a previous systematic review of existing evaluation tools.³⁰ Using this structured decision process we decided to use the Public & Patient Engagement Evaluation Tool (PPEET) because of its comprehensiveness, methodological rigour, and free-text sections.^{31, 32} This tool can be used in a wide range of settings and is centred on four main principles: integrity of design and process, influence and impact, participatory culture, and collaboration.³¹ We administered a first PPEET survey shortly after we started and based on feedback from this survey evaluation, the researchers realized a knowledge gap among some patient partners regarding their understanding of general anesthesia. In addition, it was difficult for the patients to grasp their impact on the project early on. To address these knowledge gaps, we changed the structure of our meetings (starting with a summary of the research projects, focused learning session, and patient partner impact) and also began to provide regular progress newsletters to the project team (patient partners, knowledge user organizations, and researchers) and regular oral feedback on how patient partners’ input had been incorporated into the project.

Lessons learned and suggestions for other groups

Based on our collective experiences, we—as patient partners and researchers—have been in a continuous learning cycle. A key lesson has been that patient engagement needs to be tailored to available resources and research context. We have been fortunate to be able to draw on a method centre (the Ottawa Methods Centre) that provides specific support in patient engagement in research, and we are based in a country where the main health research funding body has a dedicated funding stream for patient-oriented research. In Canada, across all provinces and territories, Support for People and Patient-Oriented Research and Trials Units provides services for researchers, patients, policy makers, and clinicians for patient-oriented research activities.³³ Regardless of the resources available to a team, we believe clinicians and researchers can and should strive to engage patients and end users in clinical research; either by a call to action within your institution or by engaging with patients in your own research depending on your local context. Less intensive levels of patient engagement (such as simply informing or consulting) can impact the project and the community as well, but we suggest teams should strive to partner with patients by engaging them in the earliest phases of the research project (ideally with patients and researchers cocreating the research question from the start) as the potential impact is stronger when initiated at the design phase. In our experience, having all interested parties (patients, clinicians, and researchers) involved early in the process was noted to be appreciated by all team members. It increased the efficiency of the process as it ensured common goals were maintained and agreed on through all phases of the project.

The team must work to build trust among all team members by communicating openly and often, developing ways to accommodate all team members. This includes identifying and removing any hierarchical barriers, and encouraging learning and participation using language patient partners can easily understand. Researchers need to show humility, and treat patients with respect for the knowledge and wisdom their lived experiences bring to the team and project. It takes time, energy and patience to engage patient partners, but the investment is worthwhile. Ultimately, the goal of clinical research is to improve clinical care and patient outcomes. Imagine the advances we can make when patient partners and researchers work together to produce and conduct research.