Paul G. Shekelle, MD, PhD; Peter J. Pronovost, MD, PhD; Robert M. Wachter, MD; Kathryn M. McDonald, MM; Karen Schoelles, MD, SM;
Sydney M. Dy, MD, MSc; Kaveh Shojania, MD; James T. Reston, PhD, MPH; Alyce S. Adams, PhD; Peter B. Angood, MD;
David W. Bates, MD, MSc; Leonard Bickman, PhD; Pascale Carayon, PhD; Sir Liam Donaldson, MBChB, MSc, MD; Naihua Duan, PhD;
Donna O. Farley, PhD, MPH; Trisha Greenhalgh, BM BCH; John L. Haughom, MD; Eileen Lake, PhD, RN; Richard Lilford, PhD;
Kathleen N. Lohr, PhD, MA, MPhil; Gregg S. Meyer, MD, MSc; Marlene R. Miller, MD, MSc; Duncan V. Neuhauser, PhD, MBA, MHA;
Gery Ryan, PhD; Sanjay Saint, MD, MPH; Stephen M. Shortell, PhD, MPH, MBA; David P. Stevens, MD; and Kieran Walshe, PhD
Over the past 12 years, since the publication of the
Institute of Medicine’s report, “To Err is Human:
Building a Safer Health System,” improving patient safety
has been the focus of considerable public and professional
interest. Although such efforts required changes in policies;
education; workforce; and health care financing, organization,
and delivery, the most important gap has arguably
been in research. Specifically, to improve patient safety we
needed to identify hazards, determine how to measure
them accurately, and identify solutions that work to reduce
patient harm. A 2001 report commissioned by the Agency
for Healthcare Research and Quality, “Making Health
Care Safer: A Critical Analysis of Patient Safety Practices”
(1), helped identify some early evidence-based safety practices,
but it also highlighted an enormous gap between
what was known and what needed to be known.
For the past 4 years, with support from the Agency for
Healthcare Research and Quality, our group (a project
team from the RAND Corporation; Stanford University;
the University of California, San Francisco; Johns Hopkins
University; and ECRI Institute) and an international panel
of 21 stakeholders and evaluation methods experts conducted
an evidence-based assessment of patient safety strategies
(PSSs). Our efforts involved 3 phases. In the first
phase, we developed a framework for reviewing existing
studies and prospectively evaluating new PSS implementation
studies (2). This framework identified several key
points about the importance of theory, context, and implementation
(Table 1) (2).
The second phase was a review of current patient
safety strategies. We started with the 79 topics in Making
Health Care Safer and added practices from the National
Quality Forum’s 2010 update, the Joint Commission, and
the Leapfrog Group; those we identified in an initial scoping
search; and those suggested by experts. From this list of
158 potential topics, we used several rounds of voting with
our stakeholders to narrow the scope to 41 PSSs that the
expert panel judged to be most important to the largest
audience. Given limited time and resources, we prioritized
topics as needing either a traditional systematic review or
only a “brief review.” The latter generally focused on a
specific aspect of the PSS, such as emerging data or new
insights about implementation.
We chose 18 topics for in-depth reviews. As a first step
for the reviews, we searched for existing relevant systematic
reviews. To assess the potential utility of such reviews, we
followed procedures proposed by Whitlock and colleagues
(3) and asked the following questions: Is the existing review
sufficiently “on topic” to be of use? Is the review of
sufficient quality to foster confidence in the results? If we
determined that the existing systematic review was sufficiently
on topic and of acceptable quality, we took 1 of 2
further steps. In some cases, we did an “update” search
(that is, we searched databases for all new relevant evidence
published since the search end date in the existing systematic
review); in others, we conducted searches for “signals
for updating.” Such searches generally followed the criteria
proposed by Shojania and colleagues (4), which involved a
search of high-yield databases and journals for pivotal studies
that could signal that a systematic review is out of date.
A pivotal study is one that may call into question the results
of a previous systematic review. We added any evidence
identified in either the update search or signals
search to the evidence base from the existing systematic
review. Some PSSs had no existing systematic reviews and
others had previous reviews that were not of sufficient relevance
or quality to be used. In those situations, we conducted
new searches using existing guidance (5).
Evidence about context, implementation, and adoption
was a key focus of our reviews. We searched for evidence
on these aspects of primary studies in 2 ways. First,
we sought and extracted data about context, implementation,
and unintended harms from articles that evaluated
the effectiveness of PSSs. Second, we identified “implementation
studies” from our literature searches. These
studies focus on the implementation processes, particularly
elements demonstrated or hypothesized to be of special
importance for the success, or lack of success, of the intervention.
To be eligible, implementation studies needed to
Ann Intern Med. 2013;158:365-368.
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either report or be linked to reports of effectiveness
outcomes.
The 23 brief reviews were explicitly designed not to be
full systematic reviews or updates. The goals of each brief
review varied by PSSs, according to needs identified by
technical experts and stakeholders. The brief review could
focus primarily on information about the effectiveness of
an emerging PSS or implementation of an established PSS.
Alternatively, the review could explore whether new evidence
calls into question the effectiveness of an existing
PSS or identifies unintended consequences of safety interventions.
In general, a content expert on the topic, working
with the project team, conducted the brief reviews. The
methods involved focused literature searches for evidence
relevant to the specific need. Typically, the author narratively
summarized the evidence in a format tailored to the
particular goal of the brief review.
We used standard instruments, such as the Cochrane
Effective Practice and Organisation of Care criteria (6), the
U.S. Preventive Services Task Force criteria (7), and the
Cochrane Risk of Bias criteria (8), to assess the quality or
risk of bias for individual studies of safety interventions.
We developed criteria to evaluate strength of evidence
across studies of effectiveness (9) that were informed by
existing methods (10, 11) and incorporated criteria about
the use of theory and description of implementation.
All of the reviews can be found in the Agency for Healthcare
Research and Quality evidence report, “Making Health
Care Safer II: An Updated Critical Analysis of the Evidence
for Patient Safety Practices” (9). In this supplement issue, we
present the reviews for 10 PSSs. In an upcoming issue of BMJ
Quality & Safety, we will present several more. A summary of
the evidence for all 41 PSSs is available in Table 1 of Chapter
44 in that report (9). It categorizes each PSS according to the
following: the scope of the underlying problem that the PSS
addresses (its frequency and severity); the strength of evidence
about the effectiveness of the safety strategy; the evidence or
potential for harmful consequences of the strategy; a rough
estimate of the cost of implementing the strategy (low, medium,
or high); and an assessment of the difficulty of implementing
the strategy.
In the last phase of our effort, the expert panel explicitly
considered the strength and quality of evidence about
effectiveness and implementation for each PSS and concluded
that 22 PSSs are ready to be encouraged for adoption
by health care providers (Table 2). The first 10 are
those that the expert panel believed should be “strongly
encouraged” for adoption. The remaining 12 are ones they
“encouraged” for adoption. Future implementation and
evaluation will further our understanding of how best to
implement these 22 practices to make them most effective
and help health care organizations become learning health
care systems. In the meantime, our expert panel believes
that providers should not delay adopting these practices,
Table 1. Recommendations for Evaluating the Effectiveness
of Patient Safety Strategies and High-Priority Contexts to
Include in Reports of Patient Safety Research*
Recommendations for evaluating the effectiveness of patient safety
strategies
Explicitly describe the theory behind the chosen intervention components
or an explicit logic model for why this patient safety practice should
work
Describe the patient safety practice in sufficient detail so it can be
replicated, including the expected effect on staff roles
Measure high-priority contexts in the 4 domains described below
Detail the implementation process, the actual effects on staff roles, and
how the implementation or intervention changed over time
Assess the effect of the patient safety practice on outcomes and possible
unexpected effects, including data on costs, when available
For studies with multiple intervention sites, assess the influence of context
on the effectiveness of the intervention and implementation
High-priority contexts to include in reports of patient safety research
External factors, such as regulatory requirements, public reporting, or
pay-for-performance, and local sentinel events
Organization structural characteristics, such as size, complexity, and
financial status or strength
Teamwork, leadership, and patient safety culture
Management tools, such as training resources, internal organization
incentives, audit and feedback, and quality improvement consultants
* From reference 2.
Table 2. Patient Safety Strategies Ready for Adoption Now
Strongly encouraged
Preoperative checklists and anesthesia checklists to prevent operative and
postoperative events
Bundles that include checklists to prevent central line–associated
bloodstream infections
Interventions to reduce urinary catheter use, including catheter reminders,
stop orders, or nurse-initiated removal protocols
Bundles that include head-of-bed elevation, sedation vacations, oral care
with chlorhexidine, and subglottic suctioning endotracheal tubes to
prevent ventilator-associated pneumonia
Hand hygiene
The do-not-use list for hazardous abbreviations
Multicomponent interventions to reduce pressure ulcers
Barrier precautions to prevent health care–associated infections
Use of real-time ultrasonography for central line placement
Interventions to improve prophylaxis for venous thromboembolisms
Encouraged
Multicomponent interventions to reduce falls
Use of clinical pharmacists to reduce adverse drug events
Documentation of patient preferences for life-sustaining treatment
Obtaining informed consent to improve patients’ understanding of the
potential risks of procedures
Team training
Medication reconciliation
Practices to reduce radiation exposure from fluoroscopy and CT
The use of surgical outcome measurements and report cards, such as
those from ACS NSQIP
Rapid-response systems
Use of complementary methods for detecting adverse events or medical
errors to monitor for patient safety problems
Computerized provider order entry
Use of simulation exercises in patient safety efforts
ACS American College of Surgeons; CT computed tomography; NSQIP
National Surgical Quality Improvement Program.
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particularly the strongly encouraged ones. Enough is
known now to permit health care systems to move ahead.
From the RAND Corporation, Santa Monica, Veterans Affairs Greater
Los Angeles Healthcare System, Los Angeles, University of California,
San Francisco, San Francisco, Stanford Center for Health Policy and
Center for Primary Care and Outcomes Research, Stanford, Kaiser Permanente,
Oakland, and University of California, Berkeley, Berkeley,
California; Johns Hopkins Medicine Patient Safety and Quality, Johns
Hopkins University, and John’s Hopkins Children’s Center, Baltimore,
Maryland; ECRI Institute, Plymouth Meeting, RAND Corporation,
Pittsburgh, and University of Pennsylvania, Philadelphia, Pennsylvania;
Centre for Patient Safety, University of Toronto, Ottawa, Ontario, Canada;
National Quality Forum, Washington, DC; Harvard University,
Brigham and Women’s Hospital, Boston, Massachusetts; Vanderbilt
University’s Peabody College, Nashville, Tennessee; University of
Wisconsin-Madison, Madison, Wisconsin; Imperial College London and
Queen Mary, University of London, London, University of Birmingham,
Edgbaston, Birmingham, and Manchester Business School, University
of Manchester, Manchester, United Kingdom; New York State
Psychiatric Institute, New York, New York; PeaceHealth Medical
Group, Eugene, Oregon; Research Triangle Institute International, Research
Triangle Park, North Carolina; Dartmouth Institute for Health
Policy and Clinical Practice, Lebanon, North Hampshire; Case Western
Reserve University, Cleveland, Ohio; and Veterans Affairs Ann Arbor
Healthcare System and University of Michigan, Ann Arbor, Michigan.
Note: The Agency for Healthcare Research and Quality reviewed contract
deliverables to ensure adherence to contract requirements and quality,
and a copyright release was obtained from the Agency for Healthcare
Research and Quality before submission of the manuscript.
Disclaimer: All statements expressed in this work are those of the authors
and should not be construed as official opinions or positions of the
organizations where any of the authors are employed, the Agency for
Healthcare Research and Quality, the U.S. Department of Health and
Human Services, or the U.S. Department of Veterans Affairs.
Acknowledgment: The authors thank Aneesa Motala, BA.
Financial Support: From the Agency for Healthcare Research and Quality,
U.S. Department of Health and Human Services (contract HHSA-
290-2007-10062I). Dr. Lilford was supported by the National Institute
of Health Research Collaborations for Leadership in Applied Health
Research and Care for Birmingham and the Black Country.
Potential Conflicts of Interest: Dr. Shekelle: Consultancy: ECRI Institute;
Employment: Veterans Affairs; Grants/grants pending: Agency for Healthcare
Research and Quality (AHRQ), Veterans Affairs, Centers for Medicare &
Medicaid Services, National Institute of Nursing Research, Office of the
National Coordinator; Royalties: UpToDate. Dr. Pronovost: Board membership:
Cantel Medical Group; Consultancy: Association for Professionals in
Infection Control and Epidemiology, Hospitals and Health Care Systems;
Grants/grants pending (money to institution): AHRQ, National Institutes of
Health; Payment for lectures: Leigh Bureau (speaking on quality and safety);
Royalties: Penguin Group. Dr. Wachter: Grant, support for travel to meetings,
payment for writing or reviewing the manuscript, grants/grants pending (money
to institution): AHRQ; Board membership: American Board of Internal Medicine,
Salem Hospital; Payment for lectures: More than 100 health care organizations
(such as hospitals, health care systems, state medical, and hospital
associations); Royalties: Lippincott, Williams & Wilkins, McGraw-Hill; Payment
for development of educational presentations (money to institution): QuantiaMD,
In-Patient Consulting—The Hospitalist Company; Stock/stock options:
PatientSafe Solutions, CRISI, EarlySense; Other: John Wiley and Sons,
Marc and Lynne Benioff, United States–United Kingdom Fulbright Commission.
Ms. McDonald: Grant (money to institution): AHRQ. Dr. Schoelles:
Support for travel to meetings and support of work on publication of “Making
Health Care Safer II” (money to institution): RAND Corporation (funded by
AHRQ). Dr. Dy: Grant (money to institution): AHRQ. Dr. Reston: Grant
(money to institution): AHRQ. Dr. Adams: Support for travel to meetings:
RAND Corporation. Dr. Bates: Consulting fee and support for travel to meetings:
RAND Corporation; Consultancy: PatientSafe Solutions; Royalties:
Medicalis; Stock/stock options: Calgary Scientific. Dr. Bickman: Support for
travel to meetings and fees for participation in review activities: RAND Corporation.
Dr. Carayon: Support for travel to meetings: RAND Corporation;
Employment: University of Wisconsin-Madison; Grants/grants pending:
AHRQ, Office of the National Coordinator; Royalties: Taylor & Francis. Dr.
Donaldson: Consulting fee and support for travel to meetings: RAND Corporation.
Dr. Farley: Grant and support for travel to meetings: AHRQ; Consultancy:
RAND Corporation, World Health Organization; Employment:
RAND Corporation. Dr. Greenhalgh: Consulting fee and support for travel to
meetings: RAND Corporation. Dr. Lake: Consulting fee and support for travel
to meetings: RAND Corporation. Dr. Lilford: Grant: National Institute of
Health Research Collaborations for Leadership in Applied Health Research
and Care for Birmingham and the Black Country; Consulting fee: AHRQ;
Support for travel to meetings: AHRQ. Dr. Lohr: Consulting fee: RAND Corporation.
Dr. Meyer: Grant: RAND Corporation; Support for travel to meetings
(money to institution): RAND Corporation; Expert testimony: Winston
Straw. Dr. Miller: Consulting fee: RAND Corporation. Dr. Neuhauser: Consulting
fee and support for travel to meetings: RAND Corporation. Dr. Ryan:
Grant, consulting fee, support for travel to meetings, fees for participation of
review activities, and payment for writing or reviewing the manuscript (money to
institution): AHRQ. Dr. Saint: Consulting fee and support for travel to meetings:
RAND Corporation (funded by AHRQ); Payment for lectures: Various
hospitals, academic medical centers, group-purchasing organizations (for example,
Veterans Health Administration and Premier), professional societies
(for example, Society of Hospital Medicine), and nonprofit foundations (for
example, Institute for Healthcare Improvement and Michigan Health and
Hospital Association); Stock/stock options: Doximity. Dr. Shortell: Support for
travel to meetings: AHRQ. Dr. Stevens: Consulting fee and support for travel to
meetings: RAND Corporation (funded by AHRQ). All other authors have
no disclosures. Disclosures can also be viewed at www.acponline.org/authors
/icmje/ConflictOfInterestForms.do?msNumM12-2931.
Requests for Single Reprints: Paul G. Shekelle, MD, PhD, RAND
Corporation, 1776 Main Street, Santa Monica, CA 90401; e-mail,
shekelle@rand.org.
Current author addresses and author contributions are available at www
.annals.org.
References
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RAND Evidence-based Practice Center under contract HHSA290200710062I.)
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Current Author Addresses: Dr. Shekelle: Veterans Affairs Greater Los
Angeles Healthcare System, 11301 Wilshire Boulevard, Los Angeles, CA
90073.
Dr. Pronovost: Johns Hopkins University School of Medicine, 1909
Thames Street, 2nd Floor, Baltimore, MD 21231.
Dr. Wachter: University of California, San Francisco, 505 Parnassus
Avenue, San Francisco, CA 94143.
Ms. McDonald: Stanford University, 117 Encina Commons, Stanford,
CA 94305-6019.
Drs. Schoelles and Reston: ECRI Institute, 5200 Butler Pike, Plymouth
Meeting, PA 19462-1298.
Dr. Dy: Johns Hopkins University, Room 609, 624 North Broadway,
Baltimore, MD 21205.
Dr. Shojania: Sunnybrook Health Sciences Centre, Room H468, 2075
Bayview Avenue, Toronto, Ontario M4N 3M5, Canada.
Dr. Adams: Kaiser Permanente, Division of Research, 2000 Broadway,
Oakland, CA 94612.
Dr. Angood: American College of Physician Executives, 400 North Ashley
Drive, Suite 400, Tampa, FL 33602.
Dr. Bates: American College of Physician Executives, 400 North Ashley
Drive, Suite 400, Tampa, FL 33602.
Dr. Bickman: Center for Evaluation and Program Improvement, Vanderbilt
University’s Peabody College, Peabody #151, 230 Appleton
Place, Nashville, TN 37203.
Dr. Carayon: University of Wisconsin-Madison, 3126 Engineering Centers
Building, 1550 Engineering Drive, Madison, WI 53706.
Dr. Donaldson: Department of Surgery & Cancer, Division of Surgery,
Imperial College London, Room 1090a, 10th Floor, QEQM Building,
St Mary’s Hospital, Praed Street, London W2 1NY, United Kingdom.
Dr. Duan: New York State Psychiatric Institute, 1051 Riverside Drive,
Unit 48, New York, NY 10032.
Dr. Farley: RAND Corporation, 4570 5th Avenue #600, Pittsburgh, PA
15213.
Dr. Greenhalgh: Global Health, Policy and Innovation Unit, Centre
for Primary Care and Public Health, Blizard Institute, Barts and The
London School of Medicine and Dentistry, Yvonne Carter Building,
58 Turner Street, London E1 2AB, United Kingdom.
Dr. Haughom: PeaceHealth, 770 East 11th Avenue, Eugene, OR 97401.
Dr. Lake: University of Pennsylvania School of Nursing, Room 302
Fagin Hall, 418 Curie Boulevard, Philadelphia, PA 19104-4217.
Dr. Lilford: University of Birmingham, Room 110, 90 Vincent Drive,
Edgbaston, Birmingham B15 2TT, United Kingdom.
Dr. Lohr: RTI International, 3040 Cornwallis Road, PO Box 12194,
Research Triangle Park, NC 27709-2194.
Dr. Meyer: Dartmouth-Hitchcock, One Medical Center Drive, Lebanon,
NH 03756.
Dr. Miller: Johns Hopkins Children’s Center, 200 North Wolfe Street,
Room 2094, Baltimore, MD 21287.
Dr. Neuhauser: Case Western Reserve University, 10900 Euclid Avenue,
Cleveland, OH 44106-4945.
Dr. Ryan: RAND Corporation, 1776 Main Street, Santa Monica, CA
90401.
Dr. Saint: Veterans Affairs Ann Arbor Healthcare System, 2215 Fuller
Road, Ann Arbor, MI 48105.
Dr. Shortell: University of California, Berkeley, 50 University Hall, MC
7360, Berkeley, CA 94720-7360.
Dr. Stevens: Dartmouth Institute for Health Policy and Clinical Practice,
30 Lafayette Street, Lebanon, NH 03766.
Dr. Walshe: University of Manchester, Booth Street West, Manchester
M15 6PB, United Kingdom.
Author Contributions: Conception and design: P.G. Shekelle, P.J. Pronovost,
R.M. Wachter, K.M. McDonald, K. Schoelles, S.M. Dy, K.
Shojania, J.T. Reston, A.S. Adams, P.B. Angood, D.W. Bates, L. Bickman,
P. Carayon, L. Donaldson, N. Duan, D.O. Farley, T. Greenhalgh,
J.L. Haughom, E. Lake, R. Lilford, K.N. Lohr, G.S. Meyer, M.R. Miller,
D.V. Neuhauser, G. Ryan, S. Saint, S.M. Shortell, D.P. Stevens, K.
Walshe.
Analysis and interpretation of the data: P.G. Shekelle, P.J. Pronovost,
R.M. Wachter, K.M. McDonald, K. Schoelles, S.M. Dy, K. Shojania,
J.T. Reston, A.S. Adams, P.B. Angood, D.W. Bates, L. Bickman, P.
Carayon, L. Donaldson, N. Duan, D.O. Farley, T. Greenhalgh, J.L.
Haughom, E. Lake, R. Lilford, K.N. Lohr, G.S. Meyer, M.R. Miller,
D.V. Neuhauser, G. Ryan, S. Saint, S.M. Shortell, D.P. Stevens, K.
Walshe.
Drafting of the article: P.G. Shekelle, P.J. Pronovost, R.M. Wachter.
Critical revision of the article for important intellectual content: P.G.
Shekelle, P.J. Pronovost, R.M. Wachter, K.M. McDonald, K. Schoelles,
S.M. Dy, K. Shojania, J.T. Reston, A.S. Adams, P.B. Angood, D.W.
Bates, L. Bickman, P. Carayon, L. Donaldson, N. Duan, D.O. Farley, T.
Greenhalgh, J.L. Haughom, E. Lake, R. Lilford, K.N. Lohr, G.S. Meyer,
M.R. Miller, D.V. Neuhauser, G. Ryan, S. Saint, S.M. Shortell, D.P.
Stevens, K. Walshe.
Final approval of the article: P.G. Shekelle, P.J. Pronovost, R.M. Wachter,
K.M. McDonald, K. Schoelles, S.M. Dy, K. Shojania, J.T. Reston,
A.S. Adams, P.B. Angood, D.W. Bates, L. Bickman, P. Carayon, L.
Donaldson, N. Duan, D.O. Farley, T. Greenhalgh, J.L. Haughom, E.
Lake, R. Lilford, K.N. Lohr, G.S. Meyer, M.R. Miller, D.V. Neuhauser,
G. Ryan, S. Saint, S.M. Shortell, D.P. Stevens, K. Walshe.
Statistical expertise: K. Shojania, N. Duan, D.V. Neuhauser.
Obtaining of funding: P.G. Shekelle, P.J. Pronovost, R.M. Wachter,
K.M. McDonald, K. Schoelles.
Collection and assembly of data: P.G. Shekelle, P.J. Pronovost, R.M.
Wachter, K.M. McDonald, K. Schoelles, S.M. Dy, K. Shojania, J.T.
Reston, A.S. Adams, P.B. Angood, D.W. Bates, L. Bickman, P. Carayon,
L. Donaldson, N. Duan, D.O. Farley, T. Greenhalgh, J.L. Haughom, E.
Lake, R. Lilford, K.N. Lohr, G.S. Meyer, M.R. Miller, D.V. Neuhauser,
G. Ryan, S. Saint, S.M. Shortell, D.P. Stevens, K. Walshe.
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