Patient safety strategies: what's proven, what isn't, what we should adopt

A review was recently published in the Annals of Internal Medicine.

It's difficult to parse because it only cites other reviews and policy documents, not primary sources. It lists ten measures “strongly encouraged” and twelve “encouraged” for “adoption now.”

The strongly encouraged measures are:

1) Pre-op and anesthesia checklists
2) Central line checklists and other bundles
3) Process interventions to reduce urinary catheter use (reminders, etc.)
4) VAP bundles
5) Hand cleaning
6) Do not use abbreviation lists
7) Interventions to reduce pressure ulcers
8) Barrier precautions
9) Ultrasound guidance for central line placement
10) Interventions to increase VTE prophylaxis

Items 1 and 2 have good evidence to support them. Anesthesia should be singled out as a remarkable success story but that effort was started decades ago and predates what we think of today as the patient safety movement. And it was done quietly, without the hype and public policy intrusions that characterize today's effort.

Interventions to reduce urinary catheter use (item 3) seem reasonable even if not evidence based. I have not formally reviewed the topic but have followed it closely and am aware of no strong research evidence that such interventions actually improve outcomes. Things are going in the right direction, though (somebody must be doing something right) based on a study I cited over a year ago demonstrating a decline in catheter related UTI. The trend cannot be attributed to Medicare's “no pay for errors” initiative concerning catheters, however, because it long predated the policy.

The evidence has been mixed concerning item 4 (VAP bundles). We are on a learning curve as to which components are most effective.

Item 5, hand washing, has been recognized as beneficial for over a century. Efforts to improve adherence are laudable. Giving it the status of a reportable measure, however, may distract from other equally if not more important infection control measures. The stethoscope, for example, of little clinical use today due to vanishing operator skill, remains in heavy use as a CPT coding instrument and is arguably as important as the hands in spreading infection (one in three stethoscopes carry MRSA).

I won't go over the rest of the top ten point by point. All are good ideas but suffer from lack of supporting evidence and/or the unintended consequences of turning them into reportable measures. Most have already been widely adopted for years if not decades.

Put mildly, items 11-22 are a little more interesting:

11) Multicomponent interventions to reduce falls
12) Use of clinical pharmacists to reduce adverse drug events
13) Documentation of patient preferences for life sustaining treatments
14) Obtaining informed consent for procedures
15) Team training
16) Medication reconciliation
17) Practices to reduce radiation exposure
18) The use of surgical outcome measures and report cards
19) Rapid response systems
20) Use of complementary methods to detect adverse events and medical errors
21) Computerized physician order entry
22) Simulation exercises

My head swims. OK, let's go through it.

11 and 12....check. We've been doing them for years.
13....pretty much implemented by law in 1990 and a nearly universal practice for many years.
14, 15....not exactly new ideas
16....med rec? Hmmm. Seems I recall that becoming a Joint Commission standard seven years ago. A wonderful idea in the abstract but a failure in the real world. Not that we shouldn't keep trying, but it's been a failure.
17....OK, why not?
18....Evidence in support of public reporting has been mixed but largely negative. It's loaded with unintended consequences.
19....Evidence for benefit from rapid response systems weighs slightly in favor of them but it is fairly weak. Almost all hospitals already have them due to Joint Commission's standard for systems to summon help for deteriorating patients.
20....OK
21....Ahh yes. CPOE. Almost all the research in support of it involves artificial surrogates. There is little if any evidence that it improves meaningful clinical outcomes. There is some evidence that it may be harmful early after adoption. In essence CPOE adds secretarial duties to the doctor's work flow thus replacing the unit secretary. Proponents argue that it eliminates a processing step thereby eliminating an opportunity for error. It is equally plausible that the eliminated step (the unit secretary) is a layer of safety and that the secretarial duties distract the doctor from clinical decision making. Well, whatever one's belief about benefit versus harm it's a moot point because we are well on our way to universal adoption. If experience with CPOE has taught us anything it's that haste magnifies the unintended consequences, so to use it for all it's worth and avoid harm we must go slow in development, training and implementation. That's why I am uncomfortable with any pressure for “adoption now” as a safety measure.
22....Simulation exercises? Sounds like a great idea. Resource intensive though. Where's the evidence?

Aside from the problem that much of the above lacks evidential support, there are no new ideas presented. Most of the measures, evidence based or not, have been widely adopted for some time. So I would find these recommendations to be of little help in advancing the cause of patient safety. But the paper does shed light on why the patient safety movement has failed to live up to its promise. The Consumers Union declared the patient safety movement a failure a decade after the IOM report which many credit with the start of the movement. More recently Bob Wachter, one of the authors of the Annals paper and an ardent systems guy to boot worried that the patient safety movement is in danger of flickering out. He cites physician burnout as one of the reasons.

So why in the world would physicians burn out on patient safety? I think it's because doctors want tools, not rules. They recognize that rules as promulgated by today's systems approaches to patient safety, being onerous and loaded with unintended consequences, should be supported by good evidence. But they're not, for the most part. And as important as systems of care are (yes, I do believe we need a systems approach to patient safety) doctors all too often see them as substitutes for thought and judgment.

Speaking of unintended consequences I'll conclude with one that deserves special mention. When the Institute of Medicine launched the patient safety movement its intention was to de-emphasize blame (as implied in the title of its report To Err is Human) in order to create a culture of transparency and facilitate reporting and analysis of adverse outcomes. But the IOM got carried away in its zeal and egregiously hyped the data on medical harm by equating it to a jumbo jet crashing daily. Even worse than hyping, the IOM actually misrepresented the study on which it based its claims, prompting a lead author of the original report to issue, in the New England Journal of Medicine, a criticism of their spin. A retraction of sorts. But it received little notice and the IOM hype took on a life of its own leading to a heightened culture of blame concerning patient safety, the opposite effect to what was originally intended. I've detailed the whole mess here and other places.