What Does the Public Know About Patient Safety and Diagnosis?

With each major anniversary of the Institute of Medicine’s To Err Is Human,¹ the patient safety community reflects on its progress and future prospects.

In 2015, To Err Is Human’s 15th anniversary coincided with another significant milestone, publication of Improving Diagnosis in Healthcare² Published by the National Academy of Medicine (NAM; successor to the Institute of Medicine), the new report presented what was known at the time about diagnostic error, how best to prevent it, and generally improve diagnosis. With the 5th and 20th anniversaries of these reports approaching, most but not all stakeholders believe that progress has been made both on diagnosis and patient safety overall.^3-5 Many also ask why the “needle” indicating advancement has not moved further and faster and what can be done to accelerate future progress.

Now, 5 years since Improving Diagnosis was published, how has awareness of diagnostic error changed? The Society to Improve Diagnosis in Medicine (SIDM), which sponsored the report, and the Coalition to Improve Diagnosis continue to enlist healthcare organizations, professional schools, malpractice insurers, and patient safety advocacy groups in efforts to prevent diagnostic error and improve diagnosis in general. Awareness of diagnosis has grown since 2015 among those who were already engaged in patient safety. It is difficult to gauge how much knowledge the general public and even healthcare professionals in general have of diagnosis as a process and its potential for error.

How well patients and the public understand the process is relevant because Goal 1 in the NAM diagnosis report is to “Facilitate more effective teamwork in the diagnostic process among health care professionals, patients and their families.”^2(p8) Teamwork with patients and families, the report suggests, can be enhanced by providing learning opportunities, inviting patient engagement in the diagnostic process, granting access to clinical information, and encouraging patients to share feedback about errors and near misses.

That sounds optimistic in an environment where many people are not aware of diagnosis as a process, much less one they need to participate in.

Researcher and consultant Michael Millenson, who first wrote about medical error in 1997,⁶ points out that most people approach information on a “need to know” basis (personal communication, October 2019). They are unlikely to study the diagnostic process until they find themselves in the midst of it. And even then, the process itself may not seem like a priority. The NAM report on diagnosis agrees and includes suggestions to encourage clinicians to address that lack of knowledge with strategies that range from improving clinician communication skills to equipping patients with checklists and scripts. Patients who will engage at that level, however, represent the minority at this time.

Adding Diagnosis to Patient Safety

Sue Sheridan, a patient activist who is now director of patient engagement for SIDM, points out that before being able to collaborate, patients and families often need an explicit invitation:

It would be very helpful if doctors would take the first step and invite patients to join them: “We need you as part of the team.” It would help if they explained that diagnosis is a process: “There will be tests, there may be some referrals, and there may be a couple of different working diagnoses.” To doctors, that might sound obvious, but we have found that patients want permission, they want an invitation to participate in their own care (personal communication, October 2019).

Sheridan has been active in patient safety since the late 1990s. In addition to her current role at SIDM, she has held leadership positions at the Centers for Medicare & Medicaid Services, the Patient-Centered Outcomes Research Institute, and the World Health Organization. She became active following the first of two devastating medical errors in her immediate family—her son, Cal, and husband, Pat. In 1995, Cal suffered a form of brain damage called kernicterus when the severity of his newborn jaundice was misdiagnosed despite his parents’ observations and repeated questions. Cal, who lives with significant disabilities, attended college and has become a professional comedian. In 1999, Pat had surgery for a mass in his cervical spine. Pathology tests identified the tumor as malignant but the report was put in a file without have been communicated to the physicians or the Sheridans. Pat’s tumor grew, and he passed away three years later, in 2002, following extensive surgeries and cancer treatment.

For years, Sue Sheridan thought of those events as medical errors, not diagnostic errors because

…back then, we didn't use that language, we didn't look through that lens. I really never thought of them as diagnostic errors until 2008, when Mark Graber invited me to speak at the very first Diagnostic Error in Medicine conference (personal communication, October 2019).

As a peer reviewer for Improving Diagnosis in Health Care, Sheridan became steeped in process and later Cal’s and Pat’s diagnostic processes in great detail for engineers at the National Academy of Sciences.

Sheridan says, “Even people who know they’ve had a medical error don’t think about diagnostic error. Patients aren’t aware of it—that’s our biggest challenge.”

Public Perceptions of Patient Safety

Ilene Corina also began working in patient safety following personal experience with medical injury. As president and founder of the Pulse Center for Patient Safety Education and Advocacy, Corina has been working to inform people in the general public about patient safety since 1996. She and Pulse’s volunteers, many of whom work in health care or are retired physicians, nurses, or pharmacists, have reached thousands of people with education and support. Through workshops, community meetings, support groups, and individual consultations, Corina and Pulse have developed a core community of people savvy about patient safety, including diagnostic error. Beyond that group, she’s not so sure:

How well does the general public understand patient safety? As much as I would love to have an answer to that question, I don’t know. (personal communication October 2019)

According to Corina, public perception is not being measured because research funding has been lacking. With modest grant funding, Corina and Pulse have worked with day laborers, members of the gay and transgender communities, young mothers, and other local groups. Corina observes that the knowledge she has developed about those groups is not the same as would be gained through a broad survey of public perceptions.

Measuring Public Perceptions of Safety

Patients’ views of safety and quality in ambulatory care, of which there are a limited number of studies, reflect a population more varied than hospital inpatients (more often the subjects of research) though still qualitatively different from the general public.

In 2016, a group of researchers in Germany conducted a systematic review⁷ of articles covering the views of patients in primary and ambulatory care regarding adverse events. The review included 19 studies; all but one published between 2004 and 2011. Thirteen of the studies took place in the United States and 1 included the US among other countries.

Across the articles reviewed, patients lacked common terminology and definitions, so their observations give a faceted rather than cohesive view of the quality and safety of care. The authors of the review article observe that most patients combine reports of “mistakes” (preferred by the public over “medical error”), such as medication and diagnostic errors, with reports of unwanted side effects from drugs and quality problems that more often relate to patient satisfaction than patient safety.

They also report that researchers in a number of the studies “recognized service quality problems as…contributing factors to technical medical errors, eg, prescriber-patient miscommunication leads to ambulatory adverse drug events.”^7(p4) And they report that some healthcare professionals and organizations are beginning to understand that poor service and quality may cause patients emotional, if not physical, harm. In time, more research will help develop greater understanding of patients’ perceptions of safety and quality, as well as effective ways to learn from patient feedback.

One of the US-based studies⁸ in the systematic review stands out for the size and diversity of the population studied. Nearly 1,700 patients with varied demographics across 7 primary care practices in North Carolina were surveyed with four questions about “medical mistakes” in ambulatory care. One of the questions asked, “Has a doctor in a doctor’s office made a wrong diagnosis or misdiagnosed you?”^8(p1481) A random sample of patients who responded “yes” to questions about wrong diagnosis or treatment were selected for personal interviews that explored their memories and perceptions of the errors in more detail. Similar to results of the systematic review, this study found “access and relationship issues” were often reported as “mistakes,” and patients struggled to distinguish treatment from diagnostic errors.

The study also asked patients if they had ever changed doctors after receiving what they perceived to be a wrong diagnosis or wrong treatment, to which 14.1% responded “yes.” In interviews, many of those patients said they were reluctant to tell the original physician they felt a mistake had been made.

Separate from efforts to reduce the incidence of medical error, the researchers feel there is a need to address the perception of mistakes with improved communication about diagnostic and therapeutic process, patient expectations, and clinical outcomes. They also note that although the study participants were demographically diverse, they all had a primary care physician and therefore were not representative of the general public.

Changing the Way We Think

By drawing back the curtain on safety lapses, To Err Is Human profoundly changed the way many people think about medical care, across a spectrum of knowledge and interest. At one end are people who became experts in patient safety science, and that population is steadily growing. At the other end is the general public, which remains largely uninformed. Most healthcare professionals fall somewhere in the middle. It is too early to tell how much effect Improving Diagnosis in Health Care will have on the problem of diagnostic error. Surveys of the public and healthcare professionals would be especially valuable to measure this impact but have yet to be funded.

Attracting and holding the attention of the public and the healthcare profession in general to the problems of patient safety and diagnostic error has been challenging and remains a priority for experts in safety and quality improvement.

Two organizations—one public, one private—joined forces recently to study this apparent lack of interest with the goal of learning how to communicate more effectively to a broad audience about the importance of patient safety, including diagnostic error.

The Betsy Lehman Center for Patient Safety, a non-regulatory state agency in Massachusetts, engaged the FrameWorks Institute, a nonprofit research group focused on improving discourse about social and scientific issues, to study currently held beliefs among stakeholders in patient safety. FrameWorks began by studying three groups: the general public, healthcare professionals, and patient safety experts. In results published in late 2017, FrameWorks found clear differences between safety experts on the one hand and healthcare professionals and the public on the other:

Our findings reveal that both groups [healthcare professionals and the public] hold deep beliefs about health, health care professionals, systems, and human nature that often contradict what experts in the field know about patient safety.^9(np)

The researchers urge experts to “reframe” how they talk about safety and to work with, not against, commonly held beliefs:

If patient safety leaders and advocates better understand how people think about patient safety, they can anticipate reactions to messages and develop communications that spark a more productive conversation —one that deepens understanding and builds support for solutions.^9(np)

The FrameWorks research is another reminder to avoid making assumptions about what people know or need to know. Sue Sheridan reminds physicians to begin with a sincere invitation. Ilene Corina observes that we don’t have good data for guidance about the general public’s views about patient safety. And Michael Millenson points out that we tend to seek information when we need it, not before.

The FrameWorks Institute urges patient safety proponents — and by extension, the diagnostic error community — to use explanatory language that ties solutions to the problem when inviting the public and not-yet-enlisted healthcare professionals to join them.