Making health care safer II: an updated critical analysis of the evidence for patient safety practices.
01 Mar 2013-Iss: 211, pp 1-945
TL;DR: The evidence supporting the effectiveness of many patient safety practices has improved substantially over the past decade, and evidence about implementation and context has also improved, but continues to lag behind evidence of effectiveness.
Abstract: Objectives To review important patient safety practices for evidence of effectiveness, implementation, and adoption. Data sources Searches of multiple computerized databases, gray literature, and the judgments of a 20-member panel of patient safety stakeholders. Review methods The judgments of the stakeholders were used to prioritize patient safety practices for review, and to select which practices received in-depth reviews and which received brief reviews. In-depth reviews consisted of a formal literature search, usually of multiple databases, and included gray literature, where applicable. In-depth reviews assessed practices on the following domains: • How important is the problem? • What is the patient safety practice? • Why should this practice work? • What are the beneficial effects of the practice? • What are the harms of the practice? • How has the practice been implemented, and in what contexts? • Are there any data about costs? • Are there data about the effect of context on effectiveness? We assessed individual studies for risk of bias using tools appropriate to specific study designs. We assessed the strength of evidence of effectiveness using a system developed for this project. Brief reviews had focused literature searches for focused questions. All practices were then summarized on the following domains: scope of the problem, strength of evidence for effectiveness, evidence on potential for harmful unintended consequences, estimate of costs, how much is known about implementation and how difficult the practice is to implement. Stakeholder judgment was then used to identify practices that were "strongly encouraged" for adoption, and those practices that were "encouraged" for adoption. Results From an initial list of over 100 patient safety practices, the stakeholders identified 41 practices as a priority for this review: 18 in-depth reviews and 23 brief reviews. Of these, 20 practices had their strength of evidence of effectiveness rated as at least "moderate," and 25 practices had at least "moderate" evidence of how to implement them. Ten practices were classified by the stakeholders as having sufficient evidence of effectiveness and implementation and should be "strongly encouraged" for adoption, and an additional 12 practices were classified as those that should be "encouraged" for adoption. Conclusions The evidence supporting the effectiveness of many patient safety practices has improved substantially over the past decade. Evidence about implementation and context has also improved, but continues to lag behind evidence of effectiveness. Twenty-two patient safety practices are sufficiently well understood, and health care providers can consider adopting them now.
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TL;DR: An extended model of the SEIPS, SEIPS 2.0 is a new human factors/ergonomics framework for studying and improving health and healthcare that describes how sociotechnical systems shape health-related work done by professionals and non-professionals, independently and collaboratively.
Abstract: Healthcare practitioners, patient safety leaders, educators and researchers increasingly recognise the value of human factors/ergonomics and make use of the discipline's person-centred models of sociotechnical systems. This paper first reviews one of the most widely used healthcare human factors systems models, the Systems Engineering Initiative for Patient Safety (SEIPS) model, and then introduces an extended model, 'SEIPS 2.0'. SEIPS 2.0 incorporates three novel concepts into the original model: configuration, engagement and adaptation. The concept of configuration highlights the dynamic, hierarchical and interactive properties of sociotechnical systems, making it possible to depict how health-related performance is shaped at 'a moment in time'. Engagement conveys that various individuals and teams can perform health-related activities separately and collaboratively. Engaged individuals often include patients, family caregivers and other non-professionals. Adaptation is introduced as a feedback mechanism that explains how dynamic systems evolve in planned and unplanned ways. Key implications and future directions for human factors research in healthcare are discussed.
773 citations
Cites methods from "Making health care safer II: an upd..."
...The SEIPS model has appeared in national reports such as Making Health Care Safer II (Shekelle et al. 2013), adopted by patient safety leaders (Gurses et al....
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TL;DR: Research and practical applications of the SEIPS model, a human factors systems approach that has been successfully applied in healthcare research and practice, are described.
494 citations
Cites background from "Making health care safer II: an upd..."
...…as a scientific discipline that can produce knowledge to redesign healthcare systems and processes and improve patient safety and quality of care (Carayon et al., 2013; Gurses et al., 2012b; Institute of Medicine, 2012; Leape et al., 2002; Pronovost and Goeschel, 2011; Pronovost and Weisfeldt,…...
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TL;DR: The present status of Choosing Wisely programs in 12 countries is described, which articulates key elements, a set of five principles, and describes the challenges countries face in the early phases of Cho choosing Wisely.
Abstract: Much attention has been paid to the inappropriate underuse of tests and treatments but until recently little attention has focused on the overuse that does not add value for patients and may even cause harm. Choosing Wisely is a campaign to engage physicians and patients in conversations about unnecessary tests, treatments and procedures. The campaign began in the United States in 2012, in Canada in 2014 and now many countries around the world are adapting the campaign and implementing it. This article describes the present status of Choosing Wisely programs in 12 countries. It articulates key elements, a set of five principles, and describes the challenges countries face in the early phases of Choosing Wisely. These countries plan to continue collaboration including developing metrics to measure overuse.
435 citations
TL;DR: Surgical checklists were associated with increased detection of potential safety hazards, decreased surgical complications and improved communication among operating staff, and represent a relatively simple and promising strategy for addressing surgical patient safety worldwide.
Abstract: Background Surgical complications represent a significant cause of morbidity and mortality with the rate of major complications after inpatient surgery estimated at 3–17% in industrialised countries. The purpose of this review was to summarise experience with surgical checklist use and efficacy for improving patient safety.
Methods A search of four databases (MEDLINE, CINAHL, EMBASE and the Cochrane Database of Controlled Trials) was conducted from 1 January 2000 to 26 October 2012. Articles describing actual use of the WHO checklist, the Surgical Patient Safety System (SURPASS) checklist, a wrong-site surgery checklist or an anaesthesia equipment checklist were eligible for inclusion (this manuscript summarises all but the anaesthesia equipment checklists, which are described in the Agency for Healthcare Research and Quality publication).
Results We included a total of 33 studies. We report a variety of outcomes including avoidance of adverse events, facilitators and barriers to implementation. Checklists have been adopted in a wide variety of settings and represent a promising strategy for improving the culture of patient safety and perioperative care in a wide variety of settings. Surgical checklists were associated with increased detection of potential safety hazards, decreased surgical complications and improved communication among operating staff. Strategies for successful checklist implementation included enlisting institutional leaders as local champions, incorporating staff feedback for checklist adaptation and avoiding redundancies with existing systems for collecting information.
Conclusions Surgical checklists represent a relatively simple and promising strategy for addressing surgical patient safety worldwide. Further studies are needed to evaluate to what degree checklists improve clinical outcomes and whether improvements may be more pronounced in particular settings.
409 citations
RAND Corporation1, Johns Hopkins University2, University of California, San Francisco3, Stanford University4, ECRI Institute5, University of Toronto6, American College of Physician Executives7, Vanderbilt University8, University of Wisconsin-Madison9, St Mary's Hospital10, Columbia University11, Queen Mary University of London12, University of Pennsylvania13, University of Birmingham14, RTI International15, Dartmouth College16, Case Western Reserve University17, University of California, Berkeley18, University of Manchester19
TL;DR: To improve patient safety the authors needed to identify hazards, determine how to measure them accurately, and identify solutions that work to reduce patient harm.
Abstract: 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.
278 citations
Cites background or methods from "Making health care safer II: an upd..."
...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....
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...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)....
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...A summary of the evidence for all 41 PSSs is available in Table 1 of Chapter 44 in that report (9)....
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...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....
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References
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Book•
01 Jan 1974TL;DR: The authors described three heuristics that are employed in making judgements under uncertainty: representativeness, availability of instances or scenarios, and adjustment from an anchor, which is usually employed in numerical prediction when a relevant value is available.
Abstract: This article described three heuristics that are employed in making judgements under uncertainty: (i) representativeness, which is usually employed when people are asked to judge the probability that an object or event A belongs to class or process B; (ii) availability of instances or scenarios, which is often employed when people are asked to assess the frequency of a class or the plausibility of a particular development; and (iii) adjustment from an anchor, which is usually employed in numerical prediction when a relevant value is available. These heuristics are highly economical and usually effective, but they lead to systematic and predictable errors. A better understanding of these heuristics and of the biases to which they lead could improve judgements and decisions in situations of uncertainty.
31,082 citations
01 Jan 2000
TL;DR: Boken presenterer en helhetlig strategi for hvordan myndigheter, helsepersonell, industri og forbrukere kan redusere medisinske feil.
Abstract: Boken presenterer en helhetlig strategi for hvordan myndigheter, helsepersonell, industri og forbrukere kan redusere medisinske feil.
16,469 citations
TL;DR: This letter is in response to your two Citizen Petitions, requesting that the Food and Drug Administration (FDA or the Agency) require a cancer warning on cosmetic talc products.
Abstract: This letter is in response to your two Citizen Petitions dated November 17, 1994 and May 13, 2008, requesting that the Food and Drug Administration (FDA or the Agency) require a cancer warning on cosmetic talc products. Your 1994 Petition requests that all cosmetic talc bear labels with a warning such as \"Talcum powder causes cancer in laboratory animals. Frequent talc application in the female genital area increases the risk of ovarian cancer.\" Additionally, your 2008 Petition requests that cosmetic talcum powder products bear labels with a prominent warning such as: \"Frequent talc application in the female genital area is responsible for major risks of ovarian cancer.\" Further, both of your Petitions specifically request, pursuant to 21 CFR 1 0.30(h)(2), a hearing for you to present scientific evidence in support of this petition.
9,350 citations
TL;DR: In hospitals with high patient- to-nurse ratios, surgical patients experience higher risk-adjusted 30-day mortality and failure-to-rescue rates, and nurses are more likely to experience burnout and job dissatisfaction.
Abstract: ContextThe worsening hospital nurse shortage and recent California legislation
mandating minimum hospital patient-to-nurse ratios demand an understanding
of how nurse staffing levels affect patient outcomes and nurse retention in
hospital practice.ObjectiveTo determine the association between the patient-to-nurse ratio and
patient mortality, failure-to-rescue (deaths following complications) among
surgical patients, and factors related to nurse retention.Design, Setting, and ParticipantsCross-sectional analyses of linked data from 10 184 staff nurses
surveyed, 232 342 general, orthopedic, and vascular surgery patients
discharged from the hospital between April 1, 1998, and November 30, 1999,
and administrative data from 168 nonfederal adult general hospitals in Pennsylvania.Main Outcome MeasuresRisk-adjusted patient mortality and failure-to-rescue within 30 days
of admission, and nurse-reported job dissatisfaction and job-related burnout.ResultsAfter adjusting for patient and hospital characteristics (size, teaching
status, and technology), each additional patient per nurse was associated
with a 7% (odds ratio [OR], 1.07; 95% confidence interval [CI], 1.03-1.12)
increase in the likelihood of dying within 30 days of admission and a 7% (OR,
1.07; 95% CI, 1.02-1.11) increase in the odds of failure-to-rescue. After
adjusting for nurse and hospital characteristics, each additional patient
per nurse was associated with a 23% (OR, 1.23; 95% CI, 1.13-1.34) increase
in the odds of burnout and a 15% (OR, 1.15; 95% CI, 1.07-1.25) increase in
the odds of job dissatisfaction.ConclusionsIn hospitals with high patient-to-nurse ratios, surgical patients experience
higher risk-adjusted 30-day mortality and failure-to-rescue rates, and nurses
are more likely to experience burnout and job dissatisfaction.
4,911 citations
TL;DR: The incidence of serious and fatal adverse drug reactions in US hospitals was found to be extremely high, and data suggest that ADRs represent an important clinical issue.
Abstract: Objective.—To estimate the incidence of serious and fatal adverse drug reactions
(ADR) in hospital patients.Data Sources.—Four electronic databases were searched from 1966 to 1996.Study Selection.—Of 153, we selected 39 prospective studies from US hospitals.Data Extraction.—Data extracted independently by 2 investigators were analyzed by a random-effects
model. To obtain the overall incidence of ADRs in hospitalized patients, we
combined the incidence of ADRs occurring while in the hospital plus the incidence
of ADRs causing admission to hospital. We excluded errors in drug administration,
noncompliance, overdose, drug abuse, therapeutic failures, and possible ADRs.
Serious ADRs were defined as those that required hospitalization, were permanently
disabling, or resulted in death.Data Synthesis.—The overall incidence of serious ADRs was 6.7% (95% confidence interval
[CI], 5.2%-8.2%) and of fatal ADRs was 0.32% (95% CI, 0.23%-0.41%) of hospitalized
patients. We estimated that in 1994 overall 2216000 (1721000-2711000) hospitalized
patients had serious ADRs and 106000 (76000-137000) had fatal ADRs, making
these reactions between the fourth and sixth leading cause of death.Conclusions.—The incidence of serious and fatal ADRs in US hospitals was found to
be extremely high. While our results must be viewed with circumspection because
of heterogeneity among studies and small biases in the samples, these data
nevertheless suggest that ADRs represent an important clinical issue.
4,764 citations