The Association of Standardized Patient Educators (ASPE) Standards of Best Practice (SOBP)

In this paper, we define the Association of Standardized Patient Educators (ASPE) Standards of Best Practice (SOBP) for those working with human role players who interact with learners in a wide range of experiential learning and assessment contexts. These human role players are variously described by such terms as standardized/simulated patients or simulated participants (SP or SPs). ASPE is a global organization whose mission is to share advances in SP-based pedagogy, assessment, research, and scholarship as well as support the professional development of its members. The SOBP are intended to be used in conjunction with the International Nursing Association for Clinical Simulation and Learning (INACSL) Standards of Best Practice: SimulationSM, which address broader simulation practices. We begin by providing a rationale for the creation of the ASPE SOBP, noting that with the increasing use of simulation in healthcare training, it is incumbent on ASPE to establish SOBP that ensure the growth, integrity, and safe application of SP-based educational endeavors. We then describe the three and a half year process through which these standards were developed by a consensus of international experts in the field. Key terms used throughout the document are defined. Five underlying values inform the SOBP: safety, quality, professionalism, accountability, and collaboration. Finally, we describe five domains of best practice: safe work environment; case development; SP training for role portrayal, feedback, and completion of assessment instruments; program management; and professional development. Each domain is divided into principles with accompanying key practices that provide clear and practical guidelines for achieving desired outcomes and creating simulations that are safe for all stakeholders. Failure to follow the ASPE SOBP could compromise the safety of participants and the effectiveness of a simulation session. Care has been taken to make these guidelines precise yet flexible enough to address the diversity of varying contexts of SP practice. As a living document, these SOBP will be reviewed and modified periodically under the direction of the ASPE Standards of Practice Committee as SP methodology grows and adapts to evolving simulation practices. Electronic supplementary material The online version of this article (doi:10.1186/s41077-017-0043-4) contains supplementary material, which is available to authorized users.


Introduction
Human simulation is a recognized methodology that involves human role players interacting with learners in a wide range of experiential learning and assessment contexts. At the inception of the practice, the human role players portrayed patients and were commonly referred to as standardized or simulated patients (SPs). In more recent years, SPs may portray an expanded scope of roles (e.g., clients, family members, healthcare professionals). There is increasing recognition that SP methodology can be applied to the work of any individual portraying a human in any simulation modality (e.g., confederates, learners playing roles other than themselves, technicians operating a manikin). At the same time, there also may be distinctions in the nature, scope, and function of those who portray roles. For example, confederates have been described as health professionals who are "planted" in a scenario to guide it while SPs act as a proxy for the person that they represent and often do not have a health professional background [1,2].
The Association of Standardized Patient Educators (ASPE) is the global organization focused on human simulation [3]. ASPE's mission is to share advances in SP-based pedagogy, assessment, research, and scholarship. It also supports the professional development of those who engage in human simulation. Therefore, it is incumbent on ASPE to pronounce underlying values and to establish Standards of Best Practice (SOBP) that ensure the growth and integrity of SP-based endeavors.
The ASPE SOBP provide clear and practical guidelines for educators who work with SPs. Care has been taken to make these guidelines precise and yet flexible enough to address the diversity of varying contexts of SP practice. Broader simulation practices are addressed in the International Nursing Association for Clinical Simulation and Learning (INACSL) Standards of Best Practice: Simulation SM [4][5][6][7][8][9][10][11]. The ASPE SOBP are intended to be used in conjunction with the INACSL standards. Potential consequences of not following the ASPE SOBP relate to compromising both the safety of participants and the effectiveness of a simulation session.

Process of SOBP development
The ASPE SOBP have been determined by the consensus opinion of a number of expert educators in the field of SP methodology. Experts have been identified as individuals who have contributed greatly to the scope and development of SP methodology, which had its inception in 1964. This consensus is based on evidence and practice, drawn from a variety of sources and methods, and reflects the perspectives of many cultures and fields of practice. In addition to citing specific references within this document, we also provide a list of essential references that informed its creation (Additional file 1: Essential Reading List).
The development of the standards began at a meeting (December, 2013) of a group of North American experts in the field of SP methodology selected by then ASPE President, Gayle Gliva-McConvey, and ASPE Standards of Practice (SOP) Committee Chair, Wendy Gammon (Table 1). A modified Delphi process [12] was used to identify domains, which form the basis of this document. A draft of this first round was presented at the January, 2014, meeting of the ASPE Board of Directors. Round two involved widening the field to include ASPE experts outside North America to review the domains and their principles ( Table 2). Round three involved a final separate consensus for unification of this document by a team of reviewers (June, 2016) drawn from the ASPE Board of Directors (Table 3). These experts made final revisions (including changing the draft's title from SOP to SOBP) and prepared this manuscript.

Terms related to SP methodology
For the purposes of this document, we will expand on some key terms relevant to SP methodology. Our understanding of these terms is aligned with the definitions in the Society for Simulation in Healthcare's (SSH) Healthcare Simulation Dictionary [13] and the INACSL Standards of Best Practice: Simulation SM Simulation Glossary [11] and, in some cases, reflects additional nuances that are emerging from our practices.
The terms standardized patient and simulated patient (SP) are often used interchangeably and refer to a person trained to portray a patient in realistic and repeatable ways. SPs interact with learners in experiential education and assessment contexts. Learners, depending on the context, are variously described as students, trainees, participants, examinees, or candidates. SPs can also provide feedback on learner performance from the perspective of the person they portray, which is unique to working with SPs. As noted in the rationale, SP-based education has grown in size and scope of practice to include many different roles. For this reason, the term simulated participant is being used as a more inclusive term to refer to all human role players in any The context in which SPs are working determines the degree of repeatability or standardization (consistency and accuracy) of their behavior, both within an individual SP's performance and between SPs portraying the same role. This behavior can be seen as part of a continuum. On one end of the continuum, in high stakes assessment, SPs may be trained to behave in a highly repeatable or standardized manner in order to give each learner a fair and equal chance and are often referred to as standardized patients. It is important to note that in this context, SPs are individuals whose behavior has been standardized. In formative educational settings, where standardization may not play an important part of the session design, carefully trained SPs are able to respond with more authenticity and flexibility to the needs of individual learners and are referred to as simulated patients.
The term actor is sometimes used to refer to an SP. While both SPs and actors are performing roles, and acting practices and theories can inform SP work, the scope of what an SP and an actor does is very different. In general, actors are fulfilling the objectives of a playwright and/or a director and perform for the entertainment of an audience. In healthcare simulation, actors may be hired to perform in an educational activity; however, as SPs, they are doing something different from actors. They are part of an educational team, focused on fulfilling the learning objectives of a simulation activity in service to learners.
We use the term client to refer to individuals or groups who contract with an SP program for various activities. The term SP educator is used to refer to those who work to develop expertise in SP methodology and are responsible for training and/or administering SPbased simulation. Some may be trainers who exclusively work with SPs, while some may be faculty or healthcare professionals who work with SPs as part of their clinical and/or academic roles.

Discussion
The SOBP are organized into five domains: safe work environment; case development; SP training for role portrayal, feedback, and completion of assessment instruments; program management; and professional development. Each domain is divided into principles with accompanying key practices. The practices are numbered for ease of reference. Not all practices are applicable to every situation, and the order in which the practices emerge may vary.
The domains are informed by five underlying values that support SP-based educational practices: safety, quality, professionalism, accountability, and collaboration ( Fig. 1). Safety is the cornerstone of simulation practice. In that regard, it is the most central of all values because safety is a principle motivation for using simulation. In turn, simulation must be conducted in a safe manner that minimizes the risk to all stakeholders, no matter the activity. Quality refers to  assuring and pursuing continuous improvement. We establish and follow standards of excellence in education, training, and research. Professionalism mandates that we are part of a community of professionals and act in accordance with common ethics, values, and standards. Accountability dictates a commitment to serving the needs of our stakeholders and informing the public about our practices. Collaboration requires sharing best practices with colleagues on a local and global scale. It is essential to the growth and development of SP-based practice.
While the domains and values are presented in separate sections, we acknowledge that they are not mutually exclusive. There are elements of all of the values in each of the domains, and there are overlapping practices that have been housed in each domain for ease of organization for the reader and to reiterate the importance of the practice (Fig. 1).
This foundational document offers both practical and at times, aspirational guidance. Future iterations of these standards will include more advanced and specialized domains, including SPs who train other SPs, facilitate sessions with learners, and act as teaching associates (e.g., in gynecological, male urogenital, and other physical examinations). This is a living document that will be reviewed and modified periodically under the direction of the ASPE Standards of Practice Committee as SP methodology grows and adapts to evolving simulation practices.

Domain 1: safe work environment
It is incumbent on simulation educators to ensure that all stakeholders-be they SPs, learners, faculty, patients, or program staff-have a safe psychological and physical learning environment (see INACSL Standard: Professional Integrity [8]). For the community of SP educators, there are three distinct principles related to creating a safe work environment: safe work practices, confidentiality, and respect.

Domain 2: case development
While curricular or programmatic goals drive teaching and evaluation activities, the design and development of materials required for SP-based contributions to these activities are critical aspects of the SP educator role. For the purpose of this document, the materials include all descriptive case documents, any supporting documents (e.g., diagrams, photos, patient education literature, rating forms), evaluation instruments, training resources (e.g., references and videos), and training protocols an SP needs to prepare for a teaching or evaluation activity. It is important to recognize that SP cases have multiple components that reflect the different users of a case, such as SP educators, SPs, learners, raters, and administrators. The development of these materials is optimized when employing a collaborative, multistep process, utilizing a set of best practice guidelines for designing simulations (see INACSL Standard: Simulation Design [9]) as well as guidelines relevant to the professional context (e.g., medicine, law). Given the importance of caserelated materials to the work of SPs, expertise in the development of teaching and evaluation materials is critical for SP educators. There are two principles that guide SP case development activities: preparation and case components.

Domain 3: SP training
SP training prepares SPs to portray roles, give feedback, and complete assessment instruments. These three areas are discrete skills, but are not mutually exclusive. It is the responsibility of the SP educator to integrate the development of these skills into SP training according to the learning objectives of the activity and the experience of the SP. Training can be done in many formats (e.g., face-to-face, online, blended). The context in which SPs work determines the degree of standardization (consistency and accuracy) of their behavior, both within an individual SP's performance and between SPs portraying the same role. SP educators apply the same training principles when preparing all simulated participants, including SPs, confederates, and others for all simulation modalities (e.g., hybrid, mixed-modality) [1,2].

Role portrayal
SP educators are expected to ensure that SP performance is consistent and accurate. Because SPs are frequently asked to engage in roles that require at least a modicum of physical and emotional vulnerability, SP educators are required to provide supportive and safe training and learning environments (see the "Domain 1: safe work environment" section).

Feedback
Feedback is critical to learning. While learners may receive feedback from many educational sources, including clinicians and peers, SP feedback provides a unique perspective. As Berenson et al (2012) note: "SPs can provide students with unique and valuable information about how their actions and behaviors affected the SP's emotional experience of the student, the SP's trust in the student, and the SP's understanding of the information exchanged. Thus, the SP's feedback fills a critical educational role in the interpersonal and affective domains" ( [14], pe-27). With appropriate training, SPs may also provide feedback on a learner's communication, clinical, or procedural skills. Effective feedback requires knowledge of the models or protocols adopted by each institution, and SP educators may train SPs in oral and written feedback strategies.

Completion of assessment instruments
The Standards for Educational and Psychological Testing define assessment as "any systematic method of obtaining information from tests and other sources, used to draw inferences about characteristics of people, objects, or programs"( [15],p72). In many assessment contexts, learners must demonstrate their competence through behavior that is assessed by observers. SPs often portray a role and observe behavior simultaneously. After an encounter, SPs may document learner performance on assessment instruments. If this is required, SP training must also focus on accurate and consistent completion of assessment instruments. SP assessments may be formative, summative, or high stakes, can take many formats (e.g., single-encounter, multi-encounter, OSCE, CPX), and use many types of assessment tools (e.g., checklists, rubrics, narrative feedback). Expectations of SP performance vary, depending on the assessment type or format.
There are five principles SP educators should follow related to SP training methodology: preparation for the training process, training for role portrayal, feedback delivery, completion of assessment instruments, and reflection on the training process.

Domain 4: program management
SP programs provide a trained cohort of SPs, expertise in SP methodology, and processes that administer SP services efficiently and cost effectively. Management in SP programs exists along a spectrum. Some programs may have one person dedicated to SP program administration and a few SPs, while others may be headed by a dedicated manager who oversees the work of many SPs, educators, and administrators. Regardless of size, SP programs are responsible for quality management practices, including quality planning, quality assurance, quality control, and quality improvement (see INACSL Standard: Professional Integrity [8]). Clearly stated policies and procedures allow an SP program to demonstrate that it meets legislated, institutional, and practice standards. They also specify approaches to meeting program goals, enable accountability to stakeholders (SPs, learners, faculty, staff), and encourage continuous improvement. There are six principles to address when managing SP programs.

Domain 5: professional development
SP educators engage in professional development to promote excellence in their own practices, within the community of practice, and among stakeholders. Professionalism has been defined for many professions that SP educators interact with, including medicine [16] and nursing [8,17]. There are intersections with some of these concepts of professionalism. However, we are an emerging, heterogeneous practice without a licensing process. These SOBP are our first cohesive attempt to articulate the standards of professionalism for our practice. We draw on Steinert's [18]