Dr. Don Berwick Responds to NEJM-published Harvard Trigger Study by Renewing Call for Automated Harm Detection

Editorial:  “Constancy of Purpose for Improving Patient Safety – Missing in Action”

Dr. Don Berwick authored an editorial on the hospital safety article published by The New England Journal of Medicine co-authored by Dr. David Bates and colleagues of the Harvard hospitals and affiliates.  He begins by referencing W. Edwards Deming’s “14 Points for Top Leaders” – “a checklist of management principles for executives who wish to nurture improvement in complex systems.”^[1]Berwick, Donald M. “Constancy of Purpose for Improving Patient Safety – Missing in Action” The New England journal of medicine vol. 388,2 (2023): 181. He explains Deming’s view that, “when leaders slacken their visible commitment to a goal, progress slows or stalls.” ^[2]Ibid

Dr. Berwick answers his own question – on whether progress has been made since the 1991 Harvard Medical Practice Study (HMPS) – later in the editorial accompanying the Bates et al findings showing that 23.6% of admitted patients are harmed:  “On the contrary, these findings suggest that the safety movement has, at best, stalled.”

This conclusion also explains the frustrations of patient advocates who co-authored in 2022 the much discussed piece, “Who Killed Patient Safety?”^[3]Hemmelgarn C, Hatlie M, Sheridan S, et al. J Patient Saf Risk Manage. 2022;27(2):56-58.

Comments on the Study

Dr. Berwick’s comments included:

• Any Progress?  The Bates et al study sought to answer the question, after “a decade-long burst of strategic activities to improve patient safety,” whether or not the nation had made progress since the 1999 publication of the landmark To Err Is Human report?  Had the national campaigns, research studies, training programs for patient safety officers, and changes in Medicare payment made a difference? ^[4]Berwick, Donald M. “Constancy of Purpose for Improving Patient Safety – Missing in Action” The New England journal of medicine vol. 388,2 (2023): 181
• Trigger-based Method.  Unlike the HMPS, Bates et al uses a trigger-based approach to identify potential adverse events, including harm not identified by HMPS.
• The findings are “Disturbing”. ^[5]Ibid:
  • 23.6% of admitted patients experienced an adverse event
  • 9% of the admissions suffered serious harm
  • 22.7% of adverse events were judged preventable 
  • Identified adverse events were consistent with the literature
  • The mean length of stay for admissions during which an adverse event occurred as more than 2x as long as for those admissions without an adverse event:  9.3 days versus 4.2 days

“This effort could hardly be timelier”

Berwick points out the timing of this study, as the 2022 National Steering Committee for Patient Safety and a national action plan released by the U.S. Agency for Healthcare Research and Quality “reached the same conclusion”, i.e. that the patient safety movement has stalled.  Moreover, the President’s Council on Advisors on Science and Technology (PCAST) “has been preparing recommendations for the President to reignite an effective patient safety movement.” ^[6]Ibid, p. 182  

Practical Implications

Dr. Berwick identifies challenges to improving patient safety illustrated by the Bates et al study:

1. Adverse event rates are highly sensitive to identification method.  “Essentially, the harder one looks for hazards and patient injuries, the more one finds.  (Voluntary reporting is so unreliable as to be nearly worthless in the calculation of rates.)”  ^[7]Ibid
2. Judging preventability is difficult and may be misleading.  “The more valuable approach is to regard all injuries as potentially preventable.”
3. Other high risk industries pay as much attention to “near misses” as to actual injury.  Neither the original HMPS or the Bates et al study addressed this.
4. Efficient, automated harm detection can be and is being done.  Unfortunately,  few health systems are doing it.  
5. Event reporting undercounts harm and is inadequate.  Many U.S. hospitals rely solely on voluntary event reporting, which “results in substantial undercounting and, in some cases, misleading reports of zero harm.”^[8]Ibid: 152

“First, do no harm.”

Dr. Berwick acknowledges that senior executives and boards of directors likely feel overwhelmed by an “onslaught of urgent priorities”:  equity; preparedness; supply chain shortages; new payment models; staff burnout; decarbonization; and more.  That said, he concludes:

“They may not welcome the duty to push patient safety back to strategic prominence. Nevertheless, ‘first do no harm’ remains a sacred obligation for all in health care, and success requires ‘constancy of purpose for improvement.’ Without renewed board and executive leadership and accountability for safety and without concerted, persistent investment in and monitoring of change, a summary study 34 years from now may again look all too familiar, with millions upon millions of patients, families, and health care staff paying the price for inaction.” ^[9]Ibid