Patient engagement can be defined as active partnership between patients, families and caregivers working together to improve healthcare delivery [1]. Patient engagement can be fostered at the individual level, clinic or organizational level, and the policy level [2]. While promoting patient engagement in individual care through self-management is better understood, less is known about clinic or organizational level patient engagement [3]. Examples of clinic or organizational-level patient engagement include patients serving on patient advisory councils, becoming members of quality improvement committees, or participating in training staff [4]. These activities allow healthcare leadership to incorporate the patient perspective and care experience when considering new clinic initiatives, quality improvement projects, or community needs.

Working with patient advisors is a promising method for achieving ongoing system-level patient engagement that can integrate with clinic quality improvement initiatives and address patient experience of care. Patient advisors are patients who meet on a regular basis with clinic staff to improve care delivery at the clinic, hospital, or organizational level. In the United States, patient advisory councils are increasingly mandated within organizations to demonstrate a commitment to patient-centered care, such as the Patient-Centered Medical Home (PCMH) delivery model, which delivers team-based, data-driven and coordinated care [5]. Patient advisory councils are an optional criteria of the 2014 US National Committee for Quality Assurance (NCQA) Patient-Centered Medical Home recognition standards, which is a national accreditation program that awards PCMH certification [6]. Patient and family advisors are also a requirement within US Accountable Care Organizations, which are groups of doctors, hospitals, and other providers who coordinate spending in order to provide quality-based care for a designated group of patients rather than service-based care, in order to share in cost savings for reduced unnecessary care [7]. In the United Kingdom, patient involvement has a historical precedent of patient participation groups providing input for NHS primary care services since the 1970’s [8]. In Australia, trained consumer representatives sit on most medical committees [9] and consumer consultant positions have been developed in mental health services [10].

A strong ethical rationale, based on principles of equity and transparency, is often cited in efforts to improve patient engagement through programs such as patient advisory councils or input from patient representatives [11]. However, there has been a lag in the evidence base assessing for any objective benefits of patient engagement at the clinic or organizational level. A systematic review conducted in 2002 by Crawford et al. identified 42 papers published between 1966 and 2000, 31 of which were case studies [12]. Their analysis reported anecdotal findings that patient input at the clinic level seemed to improve readability of educational materials and improve staff attitudes towards patients; these studies lacked formal prospective or pre-post evaluation of patient advisory activities. Another systematic review examined the impact of public involvement in articles published from 1997 to 2009, but only focused on sites in the UK [13]. Our systematic review seeks to update Crawford et al.’s 2002 review to provide a current understanding of the impact of patient advisory councils on concrete healthcare outcomes with an international scope. Initiating and maintaining a patient advisory council or other forms of patient engagement requires a commitment of staffing and other resources, thus clinics and hospital leaders may be resistant to investing in patient engagement without clear evidence to support their benefit. Our primary aim is to investigate the impact of interventions involving patient advisory councils on clinical care outcomes, patient safety, and patient satisfaction, compared to care that doesn’t involve patient advisors, for participants at all healthcare settings. Our secondary aim is to survey the impact patient advisors have on healthcare changes such as priority-setting, patient materials, and impacts on patient advisors themselves.

We conducted database search queries targeting articles involving patients serving in an advisory capacity in which authors mentioned clinical care, patient safety or patient satisfaction outcomes. This systematic review followed PRISMA guidelines (PRISMA checklist included in Additional file 1) and was registered in the PROSPERO database of the University of York Centre for Reviews and Dissemination (ID: 2015:CRD42015030020). The initial literature search was conducted from September–October 2015. Reference lists were further searched for relevant articles from October 2015 through May 2016.

To our knowledge, this is the first systematic review with a focus on patient advisors, with an emphasis on quantifiable care quality outcomes. We did not find any rigorous, prospective RCTs that assessed our primary outcomes of patient clinical care, patient safety, or patient satisfaction. We did identify a group of quasi-experimental studies from one large regional initiative in which community advisory councils aided in the development of patient-centered messaging about the importance of colorectal screening, asthma and hypertension control. While the studies showed statistically significant improvement in health behaviors, the control group included those who did not encounter the health promotion program at all rather than a control health promotion message without patient input. We cannot definitively attribute the improvements in health outcomes seen to the patient engagement component. We found only one cluster-randomized trial showing patient advisors helped clinics set priorities that were better aligned with the PCMH and chronic care model.

Despite a growing policy focus on patient-centered care, research on organizational-level patient engagement has made little progress over the 15 years that have elapsed since the publication of the 2002 Crawford systematic review. Similar to the Crawford article, we observed the most commonly found examples of advisors having an impact were on improvements to patient educational materials, clinical physical space, and changes to staff “culture” or awareness. Our review included one other systematic review of patient and public involvement in the UK, which found very similar case-based evidence within our secondary outcomes. Our review adds to these findings through our international scope and ability to capture a variety of patient advisory roles. The few experimental studies did show improvements in some clinical care metrics, clinic priorities, and staff awareness of patient engagement; however more concrete outcome measures were lacking.

Objective clinical outcomes, including quality, safety, and patient satisfaction, should be assessed in order to provide a stronger evidence base for system-level patient engagement. It is likely a challenging environment to assess these domains, given that patient advisory councils are an incredibly heterogeneous intervention. Patient advisory councils typically work on a number of projects at a given time and there are rarely joint efforts for a similar project across multiple patient advisory councils or multiple sites. Additionally, implementation of an advisory council takes significant time and resources to recruit, hold meetings, and provide follow up [53]. Implementers of advisory councils likely lack the bandwidth to incorporate formal evaluations into their work.

In order to know if patient advisory councils are actually impactful, a future research agenda for patient engagement must overcome the limitations inherent to this field. Patient advisory councils and similar patient engagement approaches are ripe for knowledge translation approach, i.e., a close, interactive relationship between researchers and health systems to accelerate evidence and improve health systems [54], Individual sites working with advisory councils should incorporate quality improvement-informed data gathering tools and consider projects as Plan-Do-Study-Act cycles with iterative analysis of improvement. For example, a hospital could assess consumer satisfaction with a waiting room space before and after an advisory council-led renovation, or assess individual patients’ self-efficacy in managing diabetes before and after using a patient advisory council-devised diabetes pamphlet. Higher quality research will require concerted efforts across healthcare sites. For example, if a healthcare network implements patient advisory councils across multiple primary care sites, central leadership could encourage a shared quality goal (improvement in standardized patient satisfaction surveys, network-wide mammogram rates, etc.) which would provide an aligned outcome that could be assessed using either a pre-post analysis, stepped-wedge, or cluster-randomized design to provide a comparison group.

The study designs utilized by the few studies that did formally evaluate patient advisory councils can serve as a guidepost for future investigators interested in assessing the impact of patient engagement. The PBRN-based public health intervention partnered with community advisory council members, who were best suited for adapting and translating evidence-based health promotion materials so as to be compelling to community members [45]. If this intervention had included a study arm providing health promotion without community advisors, it would have allowed for a more rigorous analysis of how the community advisory council input improved effectiveness. In contrast, a robust control group was included in the cluster-randomized trial of an intervention working with patient advisors to set primary care priorities; by utilizing randomization, the study addressed the many potential confounders involved in clinic-level interventions. This study established a clear comparison group of staff working without patients, allowing the investigators to identify the changes in primary care priorities that could be attributed to patient involvement [22]. A comparison group was also included in a study assessing staff awareness of patient engagement before and after working with patient partners; qualitative analysis showed an expanded and improved understanding and receptivity to patient engagement in the study arm that worked with patient and family advisors [43]. By including a control arm and/or quantitative outcome measures, these studies highlight how patient advisors may enable healthcare programs to become more patient-centered.

As healthcare becomes more consumer-focused, we have much to learn from the business and industrial design world. The studies we identified exploring experience-based co-design are a promising start to incorporating the patient perspective in healthcare improvement efforts, although they did not include reports of pre- and post-evaluation of how changes affected the care experience, which would be helpful to understand if the co-design process should be widely disseminated.

Our study limitations include regional variations in terminology. In the US, “patient engagement” is the preferred term, while in the UK “patient and public involvement” is more common. “Co-creation” and “co-production” are growing in popularity in Australia [55]. While we may not have captured all of these variations with our search strategy, we designed a search strategy aimed to capture studies that included patients as advisors regardless of the “engagement” term used. Another limitation is possible confounding of results; some studies mentioned improvements in quality or patient satisfaction measures after large-scale care redesigns across a hospital that included patient advisory councils, making it less plausible that the improvements seen could solely be attributed to the work of the patient advisors. It is also likely that positive examples of patient advisory council projects are more likely to be written up than unsuccessful ones, thus the included case studies are an example of reporting bias. The group of studies that addressed our primary outcomes of interest were from one practice-based research network in Colorado, US, thus their findings were geographically bounded in one region. Finally, we may not have captured the most recently published studies relating to patient advisory councils.

Despite these limitations, our review highlights both the strengths and challenges inherent in the field of patient engagement research. While the currently published evidence base for patient advisors is limited and primarily case-based, it does provide a description of the scope of patient advisors roles and their potential for collaboration with staff on healthcare improvement efforts, which can serve as examples for staff beginning to work with patient advisory councils. The few studies that were RCTs or quasi-experimental should serve as references for future prospective evaluations.

The studies included in this systematic review show how patient advisors have been involved in a wide range of projects oriented towards practice improvement. Patient advisors seem to help healthcare organizations develop programs that are more accessible or understandable which may translate to more effective primary care outcomes and priority setting. Case-based reports describe patient advisory council involvement in projects to improve clinical care and safety. Future work must seek rigorous evaluation of patient advisory council programs, in order to demonstrate value in the investments needed to implement patient-centered care.