Abstract
Objectives This study aims to thoroughly evaluate the frequency, severity, and preventability of adverse events that occur during perioperative care. Furthermore, it seeks to delineate the specific medical environments and professional roles implicated in these events.
Design A multicenter retrospective cohort study was implemented to gather extensive data across multiple hospitals.
Participants The study included 1,009 patients randomly selected from a substantial pool of 64,121 adults who were admitted for surgical procedures throughout the year 2018.
Conclusions Adverse events were identified in over one-third of the surgical patients, with nearly half categorized as major incidents, most of which had the potential for prevention. This alarming statistic underscores the pressing need for continuous advancements in patient safety protocols, engaging a spectrum of health professionals throughout the entirety of perioperative care.
Introduction
The essential guiding principle of medical practice, “First, do no harm,” remains paramount for ensuring patient safety within healthcare settings. However, the occurrence of adverse events during hospital admissions has emerged as a significant and prevalent issue of concern in modern medical care. Historical studies, notably the groundbreaking Harvard Medical Practice Study of the 1980s, highlighted the prevalence and preventability of such adverse events, revealing nearly half were linked to surgical operations.
In light of the transformative shifts in surgical care delivery over recent decades, a timely reassessment is crucial for establishing an accurate benchmark for patient safety. Understanding the frequency, nature, and locations of adverse events is vital to drive continuous quality enhancement in surgical practices. Reflecting the intricate scope of the original Harvard Medical Practice Study, the SafeCare study reported that adverse events were detected in nearly one-quarter of inpatient admissions in 2018. Our focus in this investigation was specifically directed at surgical and interventional procedures, given the substantial global volume of surgical operations which inherently carries significant risks for patients. Our objective was to present a precise and updated evaluation of surgical safety, delivering critical insights concerning adverse events that transpired within the hospital environment, including the incidence, severity, and potential for prevention during perioperative care for surgical patients. Furthermore, we aimed to clarify the specific locations where these events occurred as well as identifying the healthcare professionals involved, both within and outside the operating room.
Methods
Study design and population
We executed a retrospective cohort study. The established sample was curated to encompass hospitals capable of supplying dependable safety estimates for patients aged 18 years and older across diverse locations. Our selection comprised 11 hospitals that varied in size and were affiliated with three disparate healthcare systems. Among these institutions, two maintained fewer than 100 beds, four operated with a capacity of 100-200 beds, two had 201-500 beds, and the remaining three exceeded 700 beds.
Record review
Eight physicians meticulously reviewed randomly assigned summaries highlighting adverse events, engaging in classification discussions regarding each occurrence. In instances of disagreement, the categorization of the adverse event underwent revision. When adjudicators had inquiries or thought a single adverse event might warrant multiple classifications, they directed their queries back to the nursing staff for additional examination. The adjudicators evaluated the severity of each incident using a standardized severity scale that classified events as clinically significant (inflicting undue harm but resulting in a swift recovery), serious (necessitating considerable intervention or extended recovery), life threatening (indicating a potentially fatal situation requiring immediate action), or fatal (culminating in patient death). A major adverse event was classified as serious, life threatening, or fatal. Additionally, the adjudicators assessed whether harm was preventable. A potentially preventable adverse event encompassed those judged as definitively, probably, or possibly preventable. In contrast, a preventable adverse event solely included those deemed definitively or probably preventable. Finally, the adjudicators rated their confidence regarding whether the event stemmed from healthcare management. A confidence score of 4 or higher indicated an adverse event had indeed occurred, mirroring the confidence thresholds established in previous studies. Supplementary method S2 provides further insights into the rigorous record review process.
Statistical analysis
Our sampling design involved oversampling certain smaller hospitals to balance representation. Each patient’s admission record was assigned a distinct weight for analytical purposes. This weight corresponded to the inverse of the likelihood that the patient was selected, estimated based on the proportion of admission records sampled from that hospital. Thus, a sampled individual’s weight represented the number of patients in the hospital that individual represented. The implementation of these weights throughout the analyses enabled accurate estimations of the various characteristics and outcomes pertaining to the target population. Alongside weight adjustments, all 95% confidence intervals accounted for potential clustering effects within specific hospitals. Utilizing a generalized estimating equations methodology with an exchangeable correlation matrix allowed us to compute the marginal probability of adverse events.
Characteristics associated with patient admissions were reported as frequency counts and percentages for categorical variables, and means for continuous variables. Weighted adverse event rates were segmented based on severity and preventability, also detailing variations by population characteristics, insurance types, and specific surgical specialties relevant to each admission. Moreover, the weighted severity and preventability of adverse events were systematically reported according to the types of events, identified settings, and involved professions. Data analysis and manipulation employed SAS software version 9.4 to ensure reliable interpretations.
Patient and public involvement
No patients directly participated in this retrospective examination of electronic health records. Although our study commenced prior to the widespread adoption of patient and public involvement practices, we did engage with patients regarding the study and sought feedback from a community member who reviewed our manuscript submission.
Results
Study sample
Table 1
Characteristics of a weighted random sample of patients admitted to surgical care within 11 hospitals in Massachusetts, USA, showcasing numbers and percentages unless stated otherwise.
Adverse events incidence rates in weighted random sample
Among the weighted random sample of 1,009 patients admitted for surgical procedures, we detected at least one adverse event in 383 individuals (38.0%), with at least one major adverse event identified in 160 patients (15.9%). Overall, 292 admissions (28.9%) experienced at least one clinically significant adverse event, 143 admissions (14.2%) had at least one serious adverse event, while 25 admissions (2.5%) encountered one life-threatening incident, and 6 (0.6%) resulted in fatalities.
Table 2
Weighted data regarding the incidence, severity, and preventability of at least one adverse event during each hospital admission, categorized by population characteristics, insurance type, and surgical specialty associated with the admission.* Values represent number (percentage) unless specified otherwise.
In total, at least one adverse event was assessed as potentially preventable in 258 cases (25.6%), with 103 instances (10.2%) classified as probably or definitively preventable. Additionally, 85 patients (8.4%) experienced at least one potentially preventable major adverse event, and 31 patients (3.1%) sustained a major event deemed probably or definitively preventable.
Fig 1
Severity rates of adverse events assessed for each admitted patient based on preventability criteria. Events are categorized using an ordinal classification system. Adverse events are described as clinically significant (resulting in unnecessary harm but allowing rapid recovery), serious (causing substantial intervention or prolonged recovery), life threatening (provoking potentially fatal situations necessitating immediate intervention), and fatal (resulting in death). Potentially preventable adverse events comprise those assessed as definitely, probably, or possibly preventable; whereas preventable events include only those deemed definitely or probably preventable.
Table 2 illustrates the detailed incidence of adverse events among patients based on their demographic characteristics and surgical specialty. The likelihood of experiencing at least one adverse event was markedly higher among older populations, particularly those undergoing cardiovascular and thoracic surgeries compared to other specialties like orthopedic surgery, urology, and gynecology.
Fig 2
Severity ratings of adverse events for each admitted patient according to surgical specialty classification. Severity was categorized through an ascending ordinal scale. Adverse events were classified as clinically significant, serious, life threatening, and fatal. The “other” category encompasses various types of surgical disciplines including but not limited to neurosurgery, plastic reconstruction, endocrine surgery, and oral surgery.
Adverse events description in weighted random sample
A total of 593 adverse events were documented during the analyzed surgical admissions. Notably, 353 of these events (59.5%) were identified as potentially preventable, while 123 events (20.7%) were classified as probably or definitely preventable. Among the 225 major adverse events recorded, 107 (47.6%) were determined as potentially preventable and 35 (15.6%) were assessed as probably or definitively preventable.
Table 3
Weighted details concerning the severity and preventability of adverse events, organized by event type, location, and involved professions.* Values are expressed in number (percentage) unless otherwise noted.
General care units accounted for the majority of adverse events, encompassing 289 (48.8%) of all incidents, followed by the operating room with 155 events (26.1%), intensive care units with 77 cases (13.0%), recovery rooms with 20 events (3.3%), emergency departments featuring 11 incidents (1.8%), and various other in-hospital locations contributing 42 events (7.0%). Notably, adverse events occurring in operating rooms or intensive care units demonstrated higher severity levels compared to those in general care units. Attending physicians bore the highest involvement in adverse events, contributing to 531 incidents (89.5%), followed by nurses with 349 events (58.9%), residents with 294 (49.5%), advanced level practitioners with 169 (28.5%), and fellows with 68 (11.5%). Supplementary figures S2 and S3 elucidate the distribution of adverse events by setting, event type, and healthcare professions engaged.
Discussion
Two decades post the publication of the “To Err is Human” report, our study reveals that adverse events continue to be a significant issue in the provision of perioperative care across a variety of surgical specialties. Our findings indicate that over one third of patients admitted for surgical procedures experienced adverse events, with nearly half classified as major incidents that resulted in severe or life-threatening harm or death. Approximately one-fourth of all patients endured potentially preventable adverse events, with one in ten involving incidents deemed probably or definitively preventable. The predominant types of adverse events were intertwined with surgical procedures, followed closely by medication-related errors, healthcare-associated infections, and other patient care events. A significant proportion of these incidents transpired within general care units, while a notable percentage occurred within operating rooms. The attending physician, nurses, residents, and advanced level practitioners emerged as the most frequently involved professions in these adverse events.
Comparison with other studies
Strengths and limitations of this study
This investigation possesses several notable strengths alongside limitations. By utilizing a multicenter random sample of patients admitted for surgical care, we have been able to provide comprehensive estimations of adverse event incidence rates. A thorough review of medical records conducted by qualified nurses and physicians allowed for an in-depth categorization of the severity and preventability of each adverse event. However, it is noteworthy that our study population was restricted to hospitals in Massachusetts during 2018, limiting the generalizability of our findings to other healthcare settings nationwide. This constraint necessitates replication of similar studies in broader contexts outside of the United States. While larger datasets such as the US National Inpatient Sample exist, they may lack the granularity required for detailed analysis of adverse events categorized by preventability and severity, thus complicating nationwide assessments.
Additionally, our study’s retrospective design relied heavily on data accuracy from electronic health records, which, though valuable, are susceptible to inaccuracies and inconsistencies in documentation practices across different healthcare systems. These factors may introduce bias in the identification and classification of adverse events. The limited sample size further restricts the ability to provide accurate adverse event rates specific to each surgical specialty, potentially leading to overlooked events unique to certain surgical practices.
Policy implications
Our study establishes an updated reference point, illustrating that adverse events remain a prominent issue in contemporary healthcare, contributing to severe and preventable harm during hospital admissions. By dissecting the particulars of these surgical incidents, the research aimed to highlight the vital importance of post-surgical care and the participation of non-physician healthcare staff. Notably, our findings emphasize that while surgeons play a key role within operating rooms, the entire hospital staff shares the responsibility for both surgical outcomes and patient safety. Despite progress made in patient safety since the influential Harvard Medical Practice Study, tangible advancements have plateaued. The successful reduction of fatal incidents in the aviation industry over recent decades has largely been attributed to the establishment of a robust safety culture among crew members, supported by leadership commitment and transparent incident reporting.
Our results point to the persistence of errors within surgical practices, indicating an urgent need to reevaluate healthcare structures that contribute to these ongoing hurdles. Although advocating for patient safety as a collective duty for all healthcare professionals is essential, the expertise of attending physicians, who ultimately oversee patient care, must be acknowledged. In a landscape where administrative regulations increasingly dictate care delivery, concerns are rising surrounding physicians’ limited involvement in decision-making avenues. Reports highlighting moral injury, practitioner burnout, elevated turnover rates, and the resignation of healthcare professionals accentuate the importance of valuing frontline staff perspectives while fostering a cooperative environment conducive to prioritizing patient safety and enhancing the well-being of healthcare providers.
Addressing the significant premise promoted by the national surgical quality improvement initiative, this study posits that measuring adverse events is crucial to encourage patient-centric and safe care practices. However, mere participation of hospitals in quality improvement programs or performance-based remuneration linked to benchmark indicators has not yielded the anticipated advancements. A more dynamic approach that involves regular monitoring of surgical outcomes and feedback loops for healthcare professionals has the potential to mitigate patient harm progressively. Aligning with Codman’s insight, adaptive healthcare systems must adopt a transformative strategy articulated around the timely comprehension and application of all pertinent data, encompassing proactive tracking of surgical outcomes, identifying critical determinants, and working towards viable solutions.
Conclusion
The results of this comprehensive study indicate that adverse events in surgery remain both prevalent and preventable, positioning perioperative care as a notably high-risk area for patients. This reality highlights an urgent imperative to sustain and escalate efforts towards enhancing patient safety, while underscoring the importance of collective engagement from all healthcare professionals throughout the hospital system.
What is already known on this topic
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Adverse events during hospital admissions represent a significant source of patient harm.
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Large data repositories often lack the specificity needed for categorizing adverse events based on preventability, severity, setting, and involved professions through detailed electronic health record evaluations.
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A current assessment is essential to establish reference points regarding the incidence rates and characteristics of adverse events in surgical practices.
What this study adds
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The study uncovered that adverse events occurred in 38% of adults admitted for surgery, with 16% being classified as major events and 26% as potentially preventable incidents.
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These occurrences extend beyond the responsibilities of surgeons in operating rooms, indicating substantial involvement from healthcare professionals across the hospital.
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Overall, the findings reiterate that adverse events are widespread within perioperative care, leading to considerable and preventable patient harm.
Data availability statement
While the data for this study remain primarily within the purview of the immediate research team at Mass General Brigham due to confidentiality rules, deidentified data can be accessed through secured servers by contacting the principal investigator (DWB). Furthermore, both the study protocol and the detailed adverse events chart review training manual utilized for the project, along with comprehensive data management and analysis descriptions, are available upon request from interested researchers.
How can healthcare professionals improve patient safety to reduce preventable adverse events in surgery?
Of morbidity and mortality, particularly in surgical settings.
Previous studies have demonstrated a persistent occurrence of preventable adverse events within surgical populations.
Patient safety initiatives in healthcare have been initiated in response to adverse events, yet progress in reducing harm has been inconsistent.
What this study adds
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This study provides updated estimates on the incidence and preventability of adverse events across various surgical specialties, highlighting the ongoing risk in perioperative care.
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Findings indicate that a substantial proportion of adverse events are potentially preventable, pointing to opportunities for improvement in surgical practices and post-operative care.
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The study underscores the importance of collective accountability among healthcare professionals, advocating for a holistic approach to patient safety rather than isolating responsibility to surgeons alone.
