The Top Patient Safety Strategies That Can Be Encouraged for Adoption Now

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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366 5 March 2013 Annals of Internal Medicine Volume 158 • Number 5 (Part 2) www.annals.org

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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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EHC063-EF. Rockville, MD: Agency for Healthcare Research and Quality;

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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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