Introduction

Standardized or simulated patients (SPs) have become an essential aspect of medical education. They date back to the 1960s when Dr. Howard Barrows of the University of Southern California first utilized them to simulate multiple sclerosis patients and trained them to evaluate learners as well.[1] Dr. Paula Stillman of the University of Arizona is identified as another early user of SPs, training actors in the 1970s to portray mothers of child patients to assist students with acquiring appropriate histories. She is also cited as one of the first to use ‘standardized actors’ to teach physical exam and direct students on how to perform aspects of the physical correctly.[2] Building upon these successes, SPs have slowly been embraced in the medical education community, especially at the undergraduate level, where they are utilized for formative assessment in the form of the Objective Structured Clinical Exam (OSCE) and the summative evaluation in the form of the USMLE Step 2 CS.[3][4] SPs have also been utilized in graduate medical education in more formative roles and have been applied to other medical disciplines, including nursing, physical therapy, and respiratory therapy.[5] The flexibility of SPs in their ability to be utilized in multiple disciplines and multiple education levels and its superiority in the development of learner interpersonal skills all serve to emphasize the importance of having a strong standardized patient program.[6]

Curriculum Development

The methodology of SP training has been described since 1964, but only recently has there been interest in studying and standardizing the methodology of training.[7] Outside of case content, SPs require training in the specific areas of role portrayal, feedback, and use of assessment instruments. Ongoing SP programs are encouraged to incorporate trainees' reflections on the training process. The accuracy and validity of standardized patients ought to be analyzed before using them to make assessments on an individual or systems level. While SPs are well established as quality raters in the sense of interrater reliability, findings may not correlate with real patient experience. Some report that SPs tend to give physicians lower ratings compared to actual patients. This variation from true clinical experience does not undermine the utility of SPs. Rather, it indicates the need for internal validation before deployment, perhaps with a focus not on SP ratings but on whether or not these assessments lead to demonstrable changes between pre- and post-intervention clinical measures.

Role portrayal seeks to ensure that performance between SPs is both consistent and accurate. Clinician involvement is required to review case content, but SPs are also called upon to display both physical and emotional vulnerability. Ensuring a safe psychological environment is a crucial component of training in accurate role portrayal.[8] 

Educators often receive training in providing feedback, but SPs fill a unique role. Being able to give feedback on emotional connection, trust, and communication, SPs offer a rare perspective to trainees before their clinical exposure. SP educators may provide specific models of feedback used by institutions or use scripting of oral or written feedback.

SPs may offer formative or summative assessments and are expected to use assessment tools, rubrics, and narrative feedback. Trainees and SPs should have transparency regarding the assessment tools used and should be encouraged to reflect on the process to improve the training for both groups.[9]

Safety and Ethics of Standardized Patient Deployment

The safety and consent of all participants is the first concern in any standardized patient deployment. SPs should be counseled on the expectations of their role and allowed to ask questions and explore the problem space on their own terms. They must have the opportunity to refuse participation or disengage at any time; this is essential even for casual SPs, such as students and residents in "role-playing" scenarios.[10] The rigor of such briefings varies with the potential for psychological or physical compromise of the actors during the simulation. For instance, a simple intervention for conveying bad news may carry little or no risk. By contrast, portraying a patient with agitated delirium requires that both SP and clinical participants have a clear understanding of ground rules, limits on acceptable actions, and key phrases for terminating the scenario if needed.

Additional considerations abound for children, who are uniquely appealing when they can portray rare pathologies but are uniquely vulnerable. Some have suggested that very young children should not be used at all, though the exact age cutoff is debatable.[11][12][13] Projects involving children of elementary school age have reported substantial parent and child satisfaction.[14] At a minimum, parental consent is required in all cases. Parents should be present in the room or at least able to observe the encounter from a nearby area for younger children, though this requirement can be waived for adolescents. The right to refuse participation should be respected in any child old enough to understand the event and express their disinterest. Facilitators must attend to the faster onset of fatigue and stress experienced by children, and limit the duration and number of interactions accordingly.[11][12][13][15][16]

Clinical Significance

SPs have become an integral aspect of healthcare education, and in fact, are a required part of licensure in the United States. Step 2 CS, half of the second licensing exam, is a summative assessment, with medical students performing histories and physicals on multiple SPs. These SPs grade the learners on their interpersonal skills and appropriate questioning and physical examination.[4] This test is meant to confirm a minimum standard that medical students must meet to be able to continue in their education. While the SP experience in USMLE licensing is a visible sign of their significance, their utilization in OSCEs is arguably more important.

Studies have demonstrated that OSCEs are more reliable in regards to assessing learners than traditional multiple-choice question tests.[17] OSCE success is ultimately determined by reliable and consistent standardized patients who are trained to be able to give the same performance to each student and be able to improvise where appropriate to provide learners an even playing field. Appropriately trained SPs are known to be excellent raters/graders of students, with good inter-rater reliability, and often are better than faculty who are explicitly trained to rate students.[18] Studies have also demonstrated that learners acquire more developed and sophisticated emotional and communication skills when learning through SP encounters.[6] Given the multitude of evidence that supports the superiority of SPs in medical education, facilities must develop excellent SP training programs.

Enhancing Healthcare Team Outcomes

Patient Communication

Certain communication domains are either too logistically challenging or emotionally fraught to execute in situ. Most prominently, practicing the disclosure of medical errors and bad news is uniquely accessible to the SP approach. To our knowledge, however, it has not been described outside of a controlled environment, reflecting the complicated psychological challenges associated with “surprise” deployments.[10][19][20] Nonetheless, it is one of the better-studied and essential opportunities afforded by SPs. The tradition for this practice in undergraduate medical education dates back decades and is addressed elsewhere, and instead now the focus on its use amongst practicing clinicians.[21][22][23][24] As an assessment tool, SPs can identify deficits in how physicians acknowledge and take responsibility for medical errors[25], while simultaneously encouraging accurate self-assessment of disclosure competence.[26] Relatively simple sessions facilitate rapid improvement in both self-assessed skills and independent ratings.[27][28][29][30] The same benefits are found for the communication of bad news through a multitude of interventions involving SPs.[23][31][32][33]

A common theme that arises from exploring these reports is the multimodal integration of SPs with traditional didactic methods rather than the strict replacement of the former for the latter. For instance, one should strongly consider a classroom teaching session on communication best practices before having students engage with simulations. Asynchronous study before the scheduled session is also expected to have comparable benefits. Within the SP segment itself, feedback can be obtained from the SP themself, an independent observer, or participant self-reflection, often with similar accuracy objectively while providing valuable variance in subjective perspectives.

Clinical

Perhaps the most ambitious but irreplaceable application of standardized patients is the announced simulated patient, where an SP arrives in a clinic under the full pretense of a routine visit. In such cases, there is no pre-brief or other announcement that the encounter is an educational or assessment tool. The benefit is that the entire medical staff is no longer subject to the Hawthorne effect -- the changes in behavior thought to arise from knowing one is being observed.[34] It has been suggested that such medical performance during overt assessments differs substantially from true competence, a term which refers to actual clinical practice.[35][36] In situ, unannounced SPs are perhaps the only means by which a health system can accurately assess the latter on an individual basis.

Incognito SPs (ISPs), as they are sometimes called, have proven remarkably effective for identifying deficits in care across numerous types of providers and expansive geographic ranges. An assessment of the literature yields examples of ISPs in Western nations, Kenya, India, and China, to name a few, consistently demonstrating discrepancies between physician behavior and national guidelines or specialty best-practices, as well as shortcomings in physical exam skills.[37][38][39][40][41] Interestingly, these studies, at times, reinforce the concerns raised by Rethans, where the same cohort of clinicians demonstrates a good knowledge of traditional assessments, but accuracy drops precipitously in an incognito clinical setting.[38] Critically, an SP can assess every element of a practice environment. There is no reason to limit their utility to just a single provider type. Zabar et al. describe how their ISPs simultaneously identified issues with hand hygiene and screening questions performed by medical assistants, in addition to physician shortcomings.[42]

Special logistical considerations apply to the use of unannounced SPs. Health care personnel should be informed ahead of time that such patients will be deployed. This step is as much to ensure buy-in with the educational goals as it is about providing informed consent. People are unlikely to respond to feedback well if completely unaware of the project.[35][43][44][45] Despite this forewarning, however, SP detection rates are generally very low.[46] A washout period between the time of announcing the program and introducing simulated patients may help as well. That said, it may be useful for someone in the backend of the clinical practice, such as an office manager, to remain apprised of the visits, which speaks mainly to the challenges of fabricating an identity in a digital era, where frontend personnel will expect automatic confirmation of insurance information and test results. It is especially important to plan for the former, a ubiquitous feature in any setting. Workarounds include a patient presenting as self-pay or coordinating with an office manager to ensure the patient’s “insurance” is accepted. On the patient end, a detailed backstory is essential to ensuring success. The SP should have a manufactured address consistent with the geography of the clinic, a real mailing address if such correspondence is expected, and a passable photo ID for their invented identity. The actor should also consider the details of their “life,” such as information about their neighborhood, family, and hobbies, to make small talk appear natural.

The adoption of a rigorous SP program requires substantial resources, both upfront and on an ongoing basis. This likely explains why they are prevalent in the literature in small studies, but it is exceedingly difficult to find descriptions of sustained projects within a health system. This fact may relate to the absence of evidence demonstrating long-term benefits in outcome-oriented or financial metrics. However, this calculus may change as reimbursement increasingly ties to guideline adherence and patient satisfaction, not to mention the fact that patient satisfaction and doctor-patient communication are the key elements in preventing lawsuits. One must wonder how much more evidence is necessary to warrant programs that are known to identify shortcomings in all these domains, especially as large health systems become the norm in the medical landscape and have both the resources and institutional motivation for ongoing quality checks.