Patient safety — how much is enough?
Introduction
Since the Institute of Medicine reports [1], [2] we are all now very aware of the incidence and costs of preventable adverse events in health care. Hospitals have been inundated with recommendations and requirements from accreditation agencies, government departments, drug and equipment vendors, and improvement organizations. Yet little guidance is available on the relative priority of various changes, and costs and effects of most improvements have not been carefully studied. If we are to gain the maximum reduction in harm for whatever resources hospitals can put into safety, we need to collect and use cost-effectiveness evidence both to prioritize proposed safety improvements and to target new research. This paper proposes a method to generate the necessary evidence.
Section snippets
The old paradigm: the person approach
Attempting to avoid errors has been part of health care since its beginnings. Medical and nursing students are taught “First, do no harm” [3], and trained to take personal responsibility for patient safety. The person approach [4] sees errors as a failure of duty by health care providers; in this “blame, shame, and name” model, providers who are caught making errors are assumed to be incompetent, to be careless, and to deserve punishment often including banishment from providing health care in
The new paradigm: the system approach
Modern health care is a complex system, and errors are normal in complex systems [9]. The vast literature about safety in aviation (another complex system) is beginning to be reported in the medical literature [10], [11]. However, health care remains years behind other systems in learning about error reduction [1]. During the 1990s there was an explosion in information about errors and error reduction in health care, including research from the fields of cognitive psychology and human factors
Pursuing perfection?
“First, do no harm” drives health care providers to seek perfect, harm-free performance. Yet modern medicine, like modern life generally, cannot always be made perfectly safe. Holding perfection as an ideal is inspiring and perhaps necessary to discourage complacency [18]; but there can be great harm in trying to achieve it, because near-perfection often imposes near-infinite costs. The closer we get to perfection in any particular area, the more likely it becomes that we could have gotten a
Costs and benefits — why economic evaluation?
If more safety means less of “something else”, it becomes essential to ask “which something else?” What must we give up, to make health care safer? There is no one answer to this question. For example, different safety improvements may:
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cost very little, and create huge health care savings by avoiding patient injuries that can be corrected, but at great cost [22];
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cost very little, and save life, but produce little in direct health care savings;
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cost a great deal, and produce only small reductions
Setting priorities
When costs are not considered, high costs can result. Most health regions can adopt only a fraction of recommended improvements due to constrained finances and limited staff time to safely implement changes. This creates a danger of adopting improvements not in order of their cost-effectiveness, and real examples exist: the universal precautions (recommended by the US Centers for Disease Control to prevent worksite transmission of HIV to health care workers) apparently cost from $ 100,000 to $
Producing the evidence
Since even information has a cost, we need to obtain information in order of its cost-effectiveness. The economic evaluation loop (EEL) proposed here (Fig. 2) outlines a process that will ensure we direct our scarce research efforts to the areas where new information has greatest value.
In Step 1, an initial estimate is made of base-case (expected) costs and benefits (in QALYs) for all alternative strategies. This initial synthesis combines existing research, from whatever source, and may
Value added? An example
Why do we need the economic evaluation loop (EEL)? Does not research automatically produce the needed knowledge? What is added by this new framework that could possibly be worth creating yet another acronym?
We need the EEL because critical information gaps are not obvious until economic appraisal has been attempted, and sensitivity analysis performed. If we ignore costs, and focus only on effectiveness, we can easily generate a long list of “good things to do” yet have no idea which things
The way forward
What is the solution? Leape et al. [36] recommend that patient safety improvement should be based on “reasonable judgements based on the best available evidence”. They also note that “some effective practices are costly, and it would not be practical to implement all of them. Thus, it is necessary to have a method for prioritizing them whether or not they have been subjected to randomized trials. Methods for prioritizing safety practices should be a key area for future research.”
The EEL
A tale of two changes
Comparing two safety changes, one implemented several years ago and one announced recently shows the need for good evidence on costs and effects to support rational policy.
Conclusion
Basing safety improvement recommendations only on existing research evidence will not promote cost-effective reductions in patient harm. Use of the economic evaluation loop to set both implementation and research priorities for patient safety is necessary and sufficient to allow us both to gain the maximum harm reduction for our safety improvement spending, and to recognize “enough safety” when we see it. Bring on the economists!
Acknowledgements
The author thanks Dr. David Feeny (University of Alberta); Dr. Peter Norton (University of Calgary); Dr. Malcolm Maclure (University of Victoria); Dr. Robert C. Lee (University of Calgary); and the journal's anonymous reviewer, for helpful comments on evolving drafts of the paper. The author remains solely responsible for content, errors, or omissions. The author gratefully acknowledges career and research funding support from the Michael Smith Foundation for Health Research, Vancouver, BC,
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