RT Journal Article SR Electronic T1 Filling a gap in safety metrics: development of a patient-centred framework to identify and categorise patient-reported breakdowns related to the diagnostic process in ambulatory care JF BMJ Quality & Safety JO BMJ Qual Saf FD BMJ Publishing Group Ltd SP bmjqs-2021-013672 DO 10.1136/bmjqs-2021-013672 A1 Sigall K Bell A1 Fabienne Bourgeois A1 Catherine M DesRoches A1 Joe Dong A1 Kendall Harcourt A1 Stephen K Liu A1 Elizabeth Lowe A1 Patricia McGaffigan A1 Long H Ngo A1 Sandy A Novack A1 James D Ralston A1 Liz Salmi A1 Suz Schrandt A1 Sue Sheridan A1 Lauge Sokol-Hessner A1 Glenda Thomas A1 Eric J Thomas YR 2021 UL http://qualitysafety.bmj.com/content/early/2021/10/16/bmjqs-2021-013672.abstract AB Background Patients and families are important contributors to the diagnostic team, but their perspectives are not reflected in current diagnostic measures. Patients/families can identify some breakdowns in the diagnostic process beyond the clinician’s view. We aimed to develop a framework with patients/families to help organisations identify and categorise patient-reported diagnostic process-related breakdowns (PRDBs) to inform organisational learning.Method A multi-stakeholder advisory group including patients, families, clinicians, and experts in diagnostic error, patient engagement and safety, and user-centred design, co-developed a framework for PRDBs in ambulatory care. We tested the framework using standard qualitative analysis methods with two physicians and one patient coder, analysing 2165 patient-reported ambulatory errors in two large surveys representing 25 425 US respondents. We tested intercoder reliability of breakdown categorisation using the Gwet’s AC1 and Cohen’s kappa statistic. We considered agreement coefficients 0.61–0.8=good agreement and 0.81–1.00=excellent agreement.Results The framework describes 7 patient-reported breakdown categories (with 40 subcategories), 19 patient-identified contributing factors and 11 potential patient-reported impacts. Patients identified breakdowns in each step of the diagnostic process, including missing or inaccurate main concerns and symptoms; missing/outdated test results; and communication breakdowns such as not feeling heard or misalignment between patient and provider about symptoms, events, or their significance. The frequency of PRDBs was 6.4% in one dataset and 6.9% in the other. Intercoder reliability showed good-to-excellent reliability in each dataset: AC1 0.89 (95% CI 0.89 to 0.90) to 0.96 (95% CI 0.95 to 0.97); kappa 0.64 (95% CI 0.62, to 0.66) to 0.85 (95% CI 0.83 to 0.88).Conclusions The PRDB framework, developed in partnership with patients/families, can help organisations identify and reliably categorise PRDBs, including some that are invisible to clinicians; guide interventions to engage patients and families as diagnostic partners; and inform whole organisational learning.Data may be obtained from a third party and are not publicly available.