• David M Levine, Ania Syrowatka, Hojjat Salmasian, David M Shahian, Stuart Lipsitz, Jonathan P Zebrowski, Laura C Myers, Merranda S Logan, Christopher G Roy, Christine Iannaccone, Michelle L Frits, Lynn A Volk, Sevan Dulgarian, Mary G Amato, Heba H Edrees, Luke Sato, Patricia Folcarelli, Jonathan S Einbinder, Mark E Reynolds, Elizabeth Mort, and David W Bates.
• Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts (D.M.L., A.S., H.S., S.L., H.H.E.).
• Ann. Intern. Med. 2024 Jun 1; 177 (6): 738748738-748.

BackgroundDespite considerable emphasis on delivering safe care, substantial patient harm occurs. Although most care occurs in the outpatient setting, knowledge of outpatient adverse events (AEs) remains limited.ObjectiveTo measure AEs in the outpatient setting.DesignRetrospective review of the electronic health record (EHR).Setting11 outpatient sites in Massachusetts in 2018.Patients3103 patients who received outpatient care.MeasurementsUsing a trigger method, nurse reviewers identified possible AEs and physicians adjudicated them, ranked severity, and assessed preventability. Generalized estimating equations were used to assess the association of having at least 1 AE with age, sex, race, and primary insurance. Variation in AE rates was analyzed across sites.ResultsThe 3103 patients (mean age, 52 years) were more often female (59.8%), White (75.1%), English speakers (90.8%), and privately insured (70.4%) and had a mean of 4 outpatient encounters in 2018. Overall, 7.0% (95% CI, 4.6% to 9.3%) of patients had at least 1 AE (8.6 events per 100 patients annually). Adverse drug events were the most common AE (63.8%), followed by health care-associated infections (14.8%) and surgical or procedural events (14.2%). Severity was serious in 17.4% of AEs, life-threatening in 2.1%, and never fatal. Overall, 23.2% of AEs were preventable. Having at least 1 AE was less often associated with ages 18 to 44 years than with ages 65 to 84 years (standardized risk difference, -0.05 [CI, -0.09 to -0.02]) and more often associated with Black race than with Asian race (standardized risk difference, 0.09 [CI, 0.01 to 0.17]). Across study sites, 1.8% to 23.6% of patients had at least 1 AE and clinical category of AEs varied substantially.LimitationRetrospective EHR review may miss AEs.ConclusionOutpatient harm was relatively common and often serious. Adverse drug events were most frequent. Rates were higher among older adults. Interventions to curtail outpatient harm are urgently needed.Primary Funding SourceControlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.

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