the state of the evidence in patient safety kaveh g. shojania, md canada research chair in patient...
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![Page 1: The State of the Evidence in Patient Safety Kaveh G. Shojania, MD Canada Research Chair in Patient Safety and Quality Improvement Department of Medicine](https://reader035.vdocument.in/reader035/viewer/2022062422/56649f065503460f94c1c51f/html5/thumbnails/1.jpg)
The State of the Evidence The State of the Evidence
in Patient Safety in Patient Safety
Kaveh G. Shojania, MDCanada Research Chair in Patient Safety
and Quality Improvement
Department of Medicine
Sunnybrook Hospital
University of Toronto
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• Concise, evidence-based reviews of over 75 specific patient safety practices
• Over 140,000 copies obtained since publication in 2001
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Peri-operative beta-blockers to reduce cardiac complications of non-cardiac surgery
• 5 randomized trials at time of AHRQ report (2001)
– Total patients ~ 600 across all 5 trials
– Substantial benefit: 1 major event averted for every 4-8 patients treated
Received 2nd highest evidence rating in AHRQ report
• Meta-analysis of 21 trials subsequently showed questionable benefit and increases in harm (2005)
• Recent mega-trial showed increased total mortality (Devereaux et
al. Lancet 2008)
Shojania et al. Making Healthcare Safer. 2001.
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Other Examples of Major Changes or Starkly Conflicting Evidence
• Universal MRSA screening
• Hip protectors to prevent fall-related injuries
• Supplemental oxygen to decrease postoperative
infections
• Acetylcysteine to prevent contrast-nephropathy
• Rapid response teams
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• ‘Survival analysis’ of 100 meta-analyses reviewed in ACP
J Club
• Major qualitative or quantitative changes in evidence
occurred for 23% within 2 years and for 15% within 1 year
–7% were already out of date at time of publication
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• Multifaceted interventions (13 studies) showed a borderline
significant reduction in falls but not fractures
• No other strategy (hip protectors, removal of physical
restraints, fall alarm devices, changes in the physical
environment, medication review in hospital) showed
consistent, significant effects on falls, fallers, or fractures
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“Safety of Patients Isolated for Infection Control” (Stelfox et al. Jama 2003)
Isolated patients twice as likely to experience adverse events (31 vs 15 adverse events per 1000 days; P<.001).
Included significant difference in preventable events (20 vs 3 adverse events per 1000 days; P<.001)Isolated patients also more likely to• have no vital signs recorded as ordered (51% vs 31%; P<.001)
• have days with no physician progress note (26% vs 13%; P<.001)
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Catheter-related bloodstream infections showed a significant decrease from 0.62 (95% CI: 0.47 to 0.81) at baseline to 0.34 (95% CI, 0.23 to 0.50) at 18 months.
• missing data for approx 40% of ICU months
• CRBSIs definition open to bias
• no corroborating blood culture results
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Main Arguments Against Needing Evidence in Patient Safety
• Too challenging: interventions are too complex to
study using conventional EBM paradigm
• Some interventions are self-evident
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Villages…were pair-matched and randomly allocated to receive the intervention at study onset… or 3 years later…
Loans were provided to poor women who enrolled in the intervention group. A participatory learning and action curriculum was integrated into loan meetings, which took place every 2 weeks…
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Cluster RCTs in Patient Safety/QI
• Rapid response teams – Hillman et al. Lancet 2005
• Teamwork training– Nielsen et al. Obstet Gynecol. 2007
• Computerized decision support– Eccles et al. BMJ. 2002
• Feedback of acute MI performance data to hospitals– Beck et al. Jama 2005
• PDSA and Chronic Care Model
– O’Connor et al. Diabetes Care. 2005
Without these trials, we would waste huge amounts of money on
ineffective (versions of these) interventions
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“Parachute use to prevent death and major trauma related
to gravitational challenge: systematic review of
randomised controlled trials.”
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Lethal errors involving injections of concentrated KCl
Remove concentrated
potassium from clinical areas
“forcing function” that prevents
errors from happening
Concentrated KCl resembles other iv
solutions
A simple, obviously beneficial patient safety intervention
Sobering example of hospital where delays in receiving KCl from Pharmacy resulted in surreptitious hording of KCl on wards
Increase, rather than
decrease in hazard
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State of the Evidence in Patient Safety
• Superficial knowledge about epidemiology of many
important safety problems and their causes
• Few established, highly effective interventions
– most things either don’t work or we don’t know if they
work
• Those interventions that do work are often costly,
complex, and may even create new problems
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Evidence vs. Action
• Robust evidence directly
informs a minority of clinical
situations.
often treat patients on basis
of anecdotal experience
– But we don’t turn these
practices into major
recommendations
• In patient safety, robust
evidence lacking for almost
everything
individual hospitals proceed
with promising strategies
– But widespread
dissemination will require
rigorous evaluation to
confirm benefit in wide
range of settings
Auerbach et al. NEJM. 2007
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Suggested Framework for EvaluationBenefit self-evident?
Y N
RCT feasible?Monitor introduction
Y N
(cluster) RCT
Controlled Before-After Study or
Interrupted Time Series
Multivariate modelling
Y N
KCl removal
RRTs, Teamwork
P-4-PWork hour
reductions
High volume providers,
Staffing ratios
Prospective evaluation
Modified from R.J. Lilford
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Conclusions
• Evidence in patient safety still fairly sparse
– but about what one would expect for a field this young
• Scant attention to implementation issues, unintended
consequences, and costs
• Need to distinguish levels of evidence to proceed locally with
a given intervention and that required for dissemination
Precisely because of complexity and contextual factors, we
need large-scale evaluations to determine what intervention
components required to achieve benefit in which settings