A new framework developed by Boston-based researchers categorizes patient-reported problems in a way that can be used by health care providers and organizations to better understand errors in diagnoses that are unique to the ambulatory setting, where the majority of missed or delayed diagnoses occur.

Recognizing that patients and family caregivers have a unique perspective on the diagnostic process, the project’s advisory group was comprised equally of patient safety professionals and patients and families, including individuals with different racial backgrounds and persons living with chronic illness and/or disabilities and parents of children with complex medical needs.

Patients and families not only tend to see things differently from clinicians; in ambulatory care, they may be the sole observers of process breakdowns that occur between office visits. They also often have access to information, such as symptom changes and care at other settings, that is not available to clinicians. And when things don’t go well, patients and families can fill gaps in clinician-focused measures currently used to assess diagnosis and contribute information that may otherwise go missing from organizational learning.

A framework for "Patient-Reported Diagnostic Breakdowns"

Working with data from two large national surveys that included patient-reported errors in ambulatory care, the researchers and advisory group developed a framework for "Patient-Reported Diagnostic Breakdowns." One U.S population-based survey collected responses from more than 2,500 adults; the other included responses from about 28,700 patients who had access to and read clinical notes from their ambulatory visits. Both surveys were conducted in 2017.

Spanning 40 subcategories, 19 contributing factors and 11 potential impacts, the PRDB framework identifies seven areas where process breakdowns occur: access to care, medical history, physical examination, tests and referrals, explanation and next steps, communication and respect, and “other,” which included documentation- or technology-related breakdowns.

Sigall Bell, M.D., the Director of Patient Safety and Discovery for OpenNotes at the Beth Israel Deaconess Medical Center in Boston, led the research and development of the new framework. She notes that the framework “fills a gap in existing frameworks by adding the patient and family perspective, which can deepen organizational awareness of diagnostic process vulnerabilities, and establishes a foundation for more meaningful engagement of patients and families in the diagnostic process.”

In an article about the framework’s development and potential as a tool for improving diagnosis, Dr. Bell and her co-authors suggest ways organizations can use the new framework under four broad themes:

Understand

• Analyze patient-reported safety events to characterize type and frequency of diagnostic safety events.
• Categorize these diagnostic breakdowns in different clinical settings or specific populations, such as in emergency departments or among older adults.

Listen

• Train practice representatives to use framework principles when debriefing patients and families who report breakdowns in the diagnostic process.
• Structure interviews with patients and families after harmful events, such as in communication and resolution programs.
• Prompt new questions about the patient and family perspective and/or seek patient and family input when reviewing cases generated by clinicians.

Ask

• Construct pre-visit surveys to learn about patients’ priorities and main concerns and post-visit surveys for patient feedback related to the diagnostic process.
• Engage with patients and families about pending test results and care transitions.
• Inform new patient engagement tool design and assess impact of quality improvement interventions.

Learn

• Present cases in educational settings, such as Morbidity and Mortality conferences using the framework, to make visible to value of patient/family perspectives.
• Help Patient and Family Advisory Councils shape patient and community educational efforts related to improving diagnostic accuracy.
• Provide units and departments with feedback regarding common themes from aggregated PRDB data and lessons learned from the patient/family perspective.

Dr. Bell points out that the National Academy of Medicine 2015 report on diagnosis urges providers to engage with patients and families to improve diagnostic accuracy. She says, “As organizations seek to answer the call to engage patients and families in diagnosis, they will need a process and taxonomy that make sense to patients and families and align with their lived healthcare experiences.”

New online tool for engaging patients, based on framework

Working with patients and other stakeholders, Dr. Bell and her collaborator Fabienne Bourgeois, M.D., M.P.H., attending physician at Boston Children’s Hospital, used the framework to develop a new online tool, “OurDx,” to engage patients and families in the diagnostic process. Available in English and Spanish, OurDx provides a dedicated space in the electronic health record for patients to make pre-visit notes setting out their priorities, documenting symptoms and concerns, and noting potential breakdowns related to the diagnostic process. OurDx was implemented in 2021 in five clinics, including both primary care and specialty care at Boston Children’s Hospital and Dartmouth Hitchcock Medical Center.

Research related to the project describing the diagnostic error experiences of patients and families with limited English language health literacy or disadvantaged socio-economic position was presented as an oral abstract at the Society to Improve Diagnosis in Medicine’s 14^th annual conference, held online in October.