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174

ORIGINAL ARTICLE

The ‘‘To Err is Human’’ report and the patient safety

literature
H T Stelfox, S Palmisani, C Scurlock, E J Orav, D W Bates
...............................................................................................................................
Qual Saf Health Care 2006;15:174–178. doi: 10.1136/qshc.2006.017947

Background: The ‘‘To Err is Human’’ report published by the Institute of Medicine (IOM) in 1999 called for
a national effort to make health care safer. Although the report has been widely credited with spawning
efforts to study and improve safety in health care, there has been limited objective assessment of its impact.
We evaluated the effects of the IOM report on patient safety publications and research awards.
Methods: We searched MEDLINE to identify English language articles on patient safety and medical errors
published between 1 November 1994 and 1 November 2004. Using interrupted time series analyses,
changes in the number, type, and subject matter of patient safety publications were measured. We also
examined federal (US only) funding of patient safety research awards for the fiscal years 1995–2004.
See end of article for Results: A total of 5514 articles on patient safety and medical errors were published during the 10 year
authors’ affiliations study period. The rate of patient safety publications increased from 59 to 164 articles per 100 000
....................... MEDLINE publications (p,0.001) following the release of the IOM report. Increased rates of publication
Correspondence to: were observed for all types of patient safety articles. Publications of original research increased from an
Dr H T Stelfox, Department average of 24 to 41 articles per 100 000 MEDLINE publications after the release of the report (p,0.001),
of Anesthesia and Critical while patient safety research awards increased from 5 to 141 awards per 100 000 federally funded
Care, Massachusetts biomedical research awards (p,0.001). The most frequent subject of patient safety publications before the
General Hospital, 55 Fruit
Street, Clinics 309, Boston, IOM report was malpractice (6% v 2%, p,0.001) while organizational culture was the most frequent
MA 02114, USA; subject (1% v 5%, p,0.001) after publication of the report.
[email protected] Conclusions: Publication of the report ‘‘To Err is Human’’ was associated with an increased number of
Accepted for publication
patient safety publications and research awards. The report appears to have stimulated research and
9 March 2006 discussion about patient safety issues, but whether this will translate into safer patient care remains
....................... unknown.

T
he Institute of Medicine (IOM) released a report in 1999 we are beginning to see the first signs of progress.4 5 11 12
entitled ‘‘To Err is Human: Building a Safer Health System’’.1 However, objective assessment of the impact of the IOM
The report stated that errors cause between 44 000 and report has been difficult as no comprehensive nationwide
98 000 deaths every year in American hospitals, and over one monitoring system exists for patient safety.
million injuries.1 Health care appeared to be far behind other One objective and readily available measure relating to
high risk industries in ensuring basic safety. The IOM report patient safety is the health sciences literature. Although
called for a 50% reduction in medical errors over 5 years.1 Its research and academic publications will by themselves not
goal was to break the cycle of inaction regarding medical improve patient safety, they are a means of knowledge
errors by advocating a comprehensive approach to improving development and transfer and will be an integral component
patient safety. of any efforts to improve patient safety. The health sciences
This IOM report received tremendous attention from both literature and its funding also provide a gauge of the relative
the public and the healthcare industry.2 There was extensive importance and cultural attitudes towards healthcare issues.
media coverage that was closely followed by the American We therefore sought to investigate the effects of the IOM
public.2 3 The healthcare industry responded almost immedi- report ‘‘To Err is Human’’ on the publication of patient safety
ately with a wide range of patient safety efforts.4 5 The federal articles and granting of federally funded patient safety
government appropriated $50 million annually for patient research awards.
safety research.6 Non-governmental organizations issued
briefs indicating that patient safety was now a priority.5 METHODS
Healthcare purchasers such as The Leapfrog Group encour- Study design
aged hospitals to adopt safer practices and emphasized that Using data from a period of 10 years, we evaluated changes
safety was also now a priority for them.7 in patient safety publications in MEDLINE indexed journals
The 5 year anniversary of the IOM report has sparked and federal research funding associated with the release of
debate regarding its impact on patient safety and quality of the IOM report ‘‘To Err is Human’’. Changes in publications
health care.8 Critics of the report have suggested that, and research awards were estimated by interrupted time
although safety is a vital component of healthcare quality, series analysis in which rates during the 5 year periods before
the report may have done more harm than good.8 9 They and after the IOM report were compared.
contend that, by focusing undue attention on accidental
deaths which are difficult to study and prevent, limited Data sources
resources are being drawn away from other important quality Data on patient safety publications were searched using
improvement initiatives.8 10 Conversely, patient safety advo- MEDLINE. The search was conducted by identifying all
cates argue that the IOM report has galvanized the public and English language articles on patient safety, limited to
the healthcare industry into making necessary changes and humans, published between 1 January 1994 and 1 January

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Patient safety literature 175

2005 by using both medical subject headings (‘‘medical report.14 The offset for models of publications was the
errors’’, ‘‘medication errors’’, ‘‘iatrogenic disease’’, ‘‘safety logarithm of the number of MEDLINE publications per
management’’, ‘‘risk management’’, ‘‘quality assurance, 3 month interval while, for models of research awards, it was
health care’’, ‘‘patients’’, ‘‘safety’’) and keywords found in the logarithm of the total number of federally funded awards
titles and abstracts (‘‘safe’’, ‘‘safety’’, ‘‘error’’, ‘‘patient’’, each fiscal year.
‘‘medical’’, ‘‘medication’’, ‘‘non-medical’’, ‘‘nonmedical’’). We repeated all analyses for a subgroup of articles
We combined the following search terms: (1) MeSH terms published in the six general medicine journals with the
‘‘patients’’ and ‘‘safety’’; (2) MeSH term ‘‘risk management’’ highest impact factors in 2004 that published original
and keyword ‘‘safe’’; (3) MeSH term ‘‘quality assurance, research (New England Journal of Medicine, Journal of the
health care’’ and keyword ‘‘safe’’; (4) keywords ‘‘patient’’ American Medical Association, Lancet, Annals of Internal Medicine,
and ‘‘safety’’; and (5) keywords ‘‘medical’’ or ‘‘medications’’ Archives of Internal Medicine, and the British Medical Journal).15
or ‘‘non-medical’’ or ‘‘nonmedical’’ and ‘‘error’’. Finally, we Agreement on the classification of publications and
compiled articles identified by the MeSH terms ‘‘medical research awards was assessed with Cohen kappa (k)
errors’’, ‘‘medication errors’’, ‘‘iatrogenic disease’’ and ‘‘safety reliability coefficients.16 Statistical analyses were performed
management’’ with articles identified using the five combi- using Stata Version 8.0 (Stata Corp, College Station, TX,
nation search terms. USA) with two tailed significance levels of 0.05. We reported
Data on patient safety research projects funded by the results as rates, percentages, absolute percentage changes,
federal government of the USA were searched using the and odds ratios.
Computer Retrieval of Information on Scientific Projects
(CRISP) database.13 The database is maintained by the Office RESULTS
of Extramural Research at the National Institutes of Health Identification of publications and research awards
and includes projects funded by the National Institutes of The literature search identified 12 429 articles from among
Health, Substance Abuse and Mental Health Services, Health 5 207 194 MEDLINE publications between 1 January 1994
Resources and Services Administration, Food and Drug and 1 January 2005. Thirteen duplicates were identified
Administration, Centers for Disease Control and Prevention, leaving 12 416 publications for review. Patient safety or
Agency for Health Care Research and Quality, and the Office medical errors were identified as the principal focus for 5905
of the Assistant Secretary of Health. The CRISP search was publications (48%). Six articles were excluded because the
conducted by identifying all research awards for the fiscal date of publication could not be identified. Among the
years 1995–2004 using the CRISP thesaurus search terms remaining articles, 5514 were published between 1 November
‘‘patient safety’’, ‘‘medical error’’, and ‘‘iatrogenic disease’’. 1994 and 1 November 2004 in 1095 journals from 40
A team of four reviewers (RG, JM, SP and CS), blind to the countries and were included in the principal analyses. The
study hypotheses, independently reviewed in random order search of the CRISP database identified 1745 awards out of
the titles and abstracts of both the publications and research 732 826 federally funded research awards granted for the
awards identified in our two database searches. Each fiscal years 1995–2004. Patient safety or medical errors were
publication and research award was evaluated to determine identified as the principal focus for 567 (32%) of the research
whether its principal focus was patient safety or medical awards. Agreement on the classification of publications and
errors. Selected publications were classified according to research awards was good: principal publication focus on
publication type (reports of original research, editorial, letter patient safety or medical errors (agreement 86%, k = 0.71),
to the editor, review, guideline, news item or other) and publication type (agreement 74%, k = 0.67), publication
principal subject (single most relevant MeSH term not subject (agreement 60%, k = 0.57), methodology of reports
employed in the search strategy). Reports of original research of original research (agreement 68%, k = 0.58), and principal
were further classified according to their methodology research award focus on patient safety or medical errors
(qualitative studies, case reports/case series, correlational (agreement 90%, k = 0.77).
studies, cross-sectional surveys, case-control studies, cohort
studies, intervention studies, systematic reviews or decision
analyses). A fifth reviewer (HTS), blinded to the initial Changes in patient safety publications
reviews, classified a 10% random sample of publications and A large shift in the number of patient safety publications
research awards to calculate inter-rater reliabilities. followed the release of the IOM report (fig 1). An average of

Statistical analysis
No. per 100,000 MEDLINE publications

Publications were aggregated into 3 month intervals and data 200

analysis was limited to the 5 year periods before (1 November
1994 to 1 November 1999) and after (1 November 1999 to 1
November 2004) the 1 November 1999 release of the IOM 150
report. Patient safety research awards were analyzed in yearly
intervals to coincide with funding decisions for each fiscal Editorials, letters, reviews
year (1 October to 30 September). Data analysis was limited 100 guidelines and other items
to the five fiscal year periods before (1995–1999) and after
(2000–2004) the release of the IOM report.
Analyses were performed assuming a Poisson distribution. 50
We used a two step procedure to examine the data. We first Reports of original research
compared publication and research award rates before and
News items
after the release of the IOM report. Interrupted time series 0
regression models were then developed to estimate changes 95 96 97 98 99 00 01 02 03 04
in the rates of patient safety publications and research Years
awards that occurred after the release of the report. Our Before the IOM report After the IOM report
models included a constant, an offset, a baseline trend over
time, and terms estimating changes in the level and trend of Figure 1 Patient safety publications before and after publication of the
patient safety publications after the release of the IOM IOM report ‘‘To Err is Human’’.

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176 Stelfox, Palmisani, Scurlock, et al

Table 1 Types of patient safety publications

No of articles per 100 000
MEDLINE publications

Before IOM After IOM

Type of article report report Percentage change (95% CI)À p valueÀ

Original research 23.7 40.8 +72% (+55% to +91%) ,0.001

Editorials 8.6 39.1 +454% (+388% to +530%) ,0.001
Letters to the editor 9.1 23.9 +264% (+225% to +309%) ,0.001
Reviews 12.3 38.4 +313% (+274% to +358%) ,0.001
Guidelines 0.4 2.3 +516% (+264% to +1007%) ,0.001
News items 3.9 17.5 +450% (+357% to +566%) ,0.001
Other items 0.7 2.2 +301% (+72% to +524%) ,0.001

p values and 95% confidence intervals were calculated from a Poisson comparison of publication rates before and
after publication of the IOM report.

59 patient safety articles were published per 100 000 leading to an overall increase in research publications in the
MEDLINE publications in the 5 years before the IOM report; 5 year period after the IOM report. Comparing the 5 year
this increased to 164 articles per 100 000 MEDLINE publica- period before and after the IOM report, there were significant
tions in the 5 years after publication of the report (p,0.001). increases in the rates of qualitative studies, cross sectional
Even after controlling for an existing 3% per quarter upward surveys, case-control studies, intervention studies, systematic
trend (p,0.001), the rate of patient safety publications reviews, and decision analyses (table 2). No differences were
increased immediately after the release of the IOM report by observed for case reports or case series, correlational studies,
64% (p,0.001). Significantly increased rates of publication or cohort studies.
were observed for all types of patient safety articles (table 1). The number of federally funded patient safety research
Rates of patient safety publications in the top general medical awards increased after the release of the IOM report. There
journals mirrored those in MEDLINE indexed journals, was an average of five research awards per 100 000 federally
averaging four articles per 100 000 MEDLINE publications funded biomedical research awards before the IOM report
before the IOM report and 13 articles per 100 000 MEDLINE and 141 after publication of the report (p,0.001). Before the
publications after the IOM report (p,0.001). IOM report there was an existing upward trend of 62% per
fiscal year (p,0.001) in the rate of patient safety related
Changes in patient safety research research awards. After controlling for this baseline trend, the
A large increase in patient safety research followed the rate of patient safety research awards did not change
release of the IOM report (fig 2). Before the IOM report an significantly until the 2001 fiscal year when it increased by
average of 24 reports of original research were published per 569% (p,0.001).
100 000 MEDLINE publications; this increased to 41 reports
of original research per 100 000 MEDLINE publications after Changes in subject matter of patient safety
the release of the report (p,0.001). Before publication of the publications
IOM report there was a 3% per quarter upward trend Review of the patient safety articles identified 1156 unique
(p,0.001) in the rate at which reports of original research MeSH terms. After combining similar terms, 918 MeSH terms
were being published. The release of the IOM report remained. Examination of the 25 most common MeSH terms,
coincided with a fall of 21% in the rate of publication of which represented 2276 (41%) articles, suggested that the
reports of original research (p = 0.036). However, in the principal subject matter of patient safety articles was
5 year period following the IOM report the upward trend different before and after the publication of the IOM report
increased by 2% (p = 0.05) from 3% to 5% per quarter, (fig 3). The most frequent subject of patient safety publica-
tions before the IOM report was malpractice (6% v 2%,
p,0.001), while after publication of the report the most
Research awards
No. publications and awards per 100,000*

frequent subject was organizational culture (1% v 5%,

200
p,0.001).

150 DISCUSSION
We have examined the impact of the IOM report ‘‘To Err Is
Human’’ on the health sciences literature and found a
100
substantial increase in the number of patient safety publica-
tions and research awards following the release of the report.
Reports of original Increased rates of publication were observed for all types of
research patient safety articles. Publications of original research and
50
research awards were more common following the IOM
report. The subject matter of patient safety publications also
changed. Before publication of the report the most frequent
0
95 96 97 98 99 00 01 02 03 04
subject of patient safety publications was malpractice; after
Years its release the most frequent subject was organizational
culture.
Before the IOM report After the IOM report

Figure 2 Patient safety research before and after publication of the

Improving patient safety
IOM report ‘‘To Err is Human’’. *Number of patient safety research Our study provides some of the strongest evidence to date of
publications and research awards per 100 000 MEDLINE publications the impact of the report on efforts to promote patient safety.
and 100 000 federally funded biomedical research awards. Firstly, publication of the report has clearly triggered a

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Patient safety literature 177

Table 2 Methodology of reports of original research

No of articles per 100 000
MEDLINE publications

Before IOM After IOM

Methodology report report Percentage change (95% CI)À p valueÀ

Qualitative studies 1.1 3.0 +272% (+72% to +431%) ,0.001

Case reports/case series 13.3 14.9 +12% (24% to +30%) 0.144
Correlational studies 0.5 0.8 +56% (225% to +326%) 0.235
Cross-sectional surveys 3.0 9.7 +326% (+248 to +427%) ,0.001
Case-control studies 1.9 3.3 +72% (+19% to +249%) 0.004
Cohort studies 2.3 2.6 +15% (220% to +66%) 0.451
Intervention studies 1.2 4.0 +344% (+224% to +528%) ,0.001
Systematic reviews 0.3 1.5 +558% (+237% to +1319%) ,0.001
Decision analyses 0.3 1.0 +358% (+147% to +873%) 0.005

p values and 95% confidence intervals were calculated from a Poisson comparison of publication rates before and
after publication of the IOM report.

patient safety conversation in the health sciences literature. human factors engineering, psychology, and informatics
Patient safety has progressed from being the subject of creating prospects for innovative approaches to longstanding
occasional publications to being the focus of dedicated safety challenges. However, for these gains to be sustained,
issues17 and series18 19 in prominent medical journals. ongoing federal funding at present or higher levels will be
Secondly, the IOM report has changed the very nature of needed. The level of patient safety funding in future AHRQ
the patient safety conversation from focusing on dispensing budgets is uncertain.
blame to improving systems. Efforts to promote patient safety Our study also underscores how a policy report can
originated from studies in the 1990s designed to understand transform a healthcare issue into a national priority. The
medical malpractice rather than improve health care. The medical community discovered patient safety with the
IOM report introduced the concept of preventable injury publication of ‘‘To Err is Human’’. Before the report was
secondary to systems issues. A paradigm shift is underway. published there was sporadic interest in patient safety that
Thirdly, patient safety is a new field and both time and stable accompanied high profile medical journal articles or media
funding are needed for meaningful research to develop. coverage of sensational medical errors.23 The Harvard Medical
Many of the largest patient safety studies were published Practice study was published in 1991, yet it was the IOM
before the IOM report.20–22 There has been a limited increase report that widely publicized the fact that between 44 000
in the number of research publications. However, a distinct and 98 000 people die in hospitals each year because of
change in the methodology of these publications has already preventable medical errors.20 The IOM report also persona-
emerged with a new emphasis on interventions to improve lized the discussion of patient safety by recalling previous
patient safety. In addition, health sciences researchers are celebrity patients such as Libby Zion and Betsy Lehman who
increasingly collaborating with scientists from fields of had died from medical errors.23 Finally, the report quantified

No. Articles
Subject Odds ratio Before After
IOM IOM
Operative complications 47 37
Malpractice 83 87
Sentinel surveillance 32 37
Drug prescription 54 98
Clinical competence 24 47
Risk factors 23 51
Medication systems 37 83
Equipment safety 25 71
Drug labeling 25 73
Anesthesia 16 48
ADE reporting systems 19 62
Blood transfusion 18 64
Quality of health care 34 124
Communication 11 46
Attitude of health personnel 11 48
Truth disclosure 19 91
Outcome and process assessment 9 46
Information systems 12 72
Systems analysis 8 59
Education 6 52
Patient care 5 47
Medical records systems 4 46
JCAHO 4 54
Organizational culture 15 227
Personnel staffing and scheduling 3 62

0.1 0.3 1 5 20
More likely More likely
Before IOM report After IOM report

Figure 3 Principal subject of patient safety publications before and after publication of the IOM report ‘‘To Err is Human’’.

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178 Stelfox, Palmisani, Scurlock, et al

the impact of medical errors on patient safety using the simple reviews; and David Blumenthal, Clifford Deutschman, and Donald
yet stunning analogy of one jumbo jet crashing per day. Redelmeier for their comments on an earlier version of the manu-
‘‘To Err is Human’’ illustrates the impact that a simple call script.
to action can have. However, it is now more important than .....................
ever for the medical community to evaluate objectively the
Authors’ affiliations
progress in efforts to promote patient safety. As time passes H T Stelfox, Department of Anesthesia and Critical Care, Massachusetts
the paucity of evidence that patients are safer today than they General Hospital and Harvard Medical School, Boston, MA, USA
were before the report was published is allowing critics S Palmisani, Department of Anesthesia and Intensive Care Medicine,
increasingly to question the role of patient safety within ‘‘La Sapienza’’ University, II Faculty of Medicine, Sant’ Andrea Hospital,
healthcare quality. Brennan et al8 have argued that patient Rome, Italy
safety is something of a fad and not as important a priority as C Scurlock, Department of Anesthesia, Mount Sinai Hospital and School
quality, so that investment would be better directed at quality of Medicine, New York, NY, USA
than safety. We believe that separating patient safety from E J Orav, D W Bates, Division of General Medicine, Department of
Medicine, Brigham and Women’s Hospital and Harvard Medical
healthcare quality represents a false dichotomy because
School, Boston, MA, USA
patient safety is a first step in providing quality care, and D W Bates, Partners HealthCare Systems, Boston, MA, USA
that both are valuable. The problem is that, historically,
efforts to promote patient safety as well as broader efforts to Dr Stelfox was supported by a Postdoctoral Fellowship award from the
Canadian Institutes of Health Research. Funding sources had no role in
promote healthcare quality have received limited attention
the design, conduct, or reporting of this study.
and funding. ‘‘To Err is Human’’ has provided a window of
opportunity for improving patient safety in health care. The Competing interests: none.
current focus on patient safety should not discourage
healthcare quality advocates. Rather, there is a need for
continued patient safety research support and increased REFERENCES
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The ''To Err is Human'' report and the patient

safety literature
H T Stelfox, S Palmisani, C Scurlock, E J Orav and D W Bates

Qual Saf Health Care 2006 15: 174-178

doi: 10.1136/qshc.2006.017947

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