John Williams points to this post by Brad Spellberg, Jaimo Ahn, Robert Centor, who write:
Clinical guidelines greatly influence how doctors care for their patients. . . . Regulators, insurance payers and lawyers can also use guidelines to manage a doctor’s performance, or as evidence in malpractice cases. Often, guidelines compel doctors to provide care in specific ways.
We are physicians who share a common frustration with guidelines based on weak or no evidence. We wanted to create a new approach to medical guidelines built around the humility of uncertainty, in which care recommendations are only made when data is available to support the care. In the absence of such data, guidelines could instead present the pros and cons of various care options.
This sounds like a great idea.
Spellberg et al. continue:
The clinical guidelines movement first began to gain steam in the 1960s. Guideline committees, usually composed of subspecialty experts from academic medical centers, would base care criteria on randomized clinical trials, considered the gold standard of empirical evidence.
So far so good, as long as we recognize that the so-called gold standard isn’t always so good: what with dropout etc., randomized trials have biases too, also there are the usual problems with summarizing studies based on statistical significance or lack thereof, and meta-analysis can be a disaster when averaging experiments of varying quality.
In any case, misinterpretation of randomized trials can be the least of our problems. Spellberg et al. write:
Unfortunately, many committees have since started providing answers to clinical questions even without data from high-quality clinical trials. Instead, they have based recommendations primarily on anecdotal experiences or low-quality data.
Interesting point. If doctors, payers, and regulators are wanting or expecting “guidelines,” then what sort of guidelines do you get when available knowledge is insufficient for strong guidelines? You can see the problem.
Spellberg et al. give several examples where rough-and-ready guidelines led to bad outcomes, and then they give their proposal, which is a more open-ended, and open, approach to creating consensus-based guidelines that recognize uncertainty:
To create a new form of medical guideline that takes the strength of available evidence for a particular practice into account, we gathered 60 other physicians and pharmacists from eight countries on Twitter to draft the first WikiGuideline. Bone infections were voted as the conditions most in need of new guidelines.
We all voted on seven questions about bone infection diagnosis and management to include in the guideline, then broke into teams to generate answers. Each volunteer searched the medical literature and drafted answers to a clinical question based on the data. These answers were repeatedly revised in open dialogue with the group.
These efforts ultimately generated a document with more than 500 references and provided clarity to how providers currently manage bone infections. Of the seven questions we posed, only two had sufficient high-quality data to make a “clear recommendation” on how providers should treat bone infection. The remaining five questions were answered with reviews that provided pros and cons of various care options.
They contrast to the existing standard approach to medical guidelines:
The recommendations WikiGuidelines arrived at differ from current bone infection guidelines by professional group for medical specialists. For example, WikiGuidelines makes a clear recommendation to use oral antibiotics for bone infections based on numerous randomized controlled trials. Current standard guidelines, however, recommend giving intravenous antibiotics, despite the evidence that giving treatment orally is not only just as effective as giving it intravenously, but is also safer and results in fewer side effects.
Interesting. I recognize that I’m hearing only one side of the story. That said, their argument sounds persuasive to me, and of course I’m generally receptive to statements about the importance of recognizing uncertainty.
So I hope this WikiGuidelines for medicine works out and that similar procedures can be done in other fields. The next question will be, who’s on the committee? It could be that it’s easier to get a nonaligned committee for a guideline on bone infections than for something more controversial such as nudge interventions.
I’m all for efforts like this – but there is a political aspect that will make such things difficult. Practice guidelines are part of standard care which has financial implications for what is and is not covered by insurers. True recognition of uncertainty is likely to lead to increased discretion on the part of providers, something I would welcome. However, other parties might resist giving providers more discretion – one way to control costs is to be more authoritarian regarding what is considered acceptable practice. There are also legal impacts associated with the definition of standard care. Ultimately, there will be a tension related to an ongoing power struggle between medical providers and those that pay the bills. So, I think this effort may face an uphill battle. Nonetheless, I think it is a welcome development.
This type of guideline development already exists, at least for cancer screening. I would refer the authors to USPSTF, their rating system, and the evidence review performed for USPSTF by evidence-based practice centers for various cancers.
There have been oncology guidelines for around twenty years set up by the National Comprehensive Cancer Network which is a consortium of centers of excellence. The recommendations are set out in a workflow type of chart. They are quite useful for the in the trenches everyday doc as I was. One does often encounter decision points that require subjective input, but that is the nature of the beast. The “best” treatment known is sometimes based on imperfect studies; actually almost all studies are imperfect in the real world. I think that the guidelines are better than the preexisting system based on deference to authority (and one must say the personal interests, including financial, of the provider).
How well do these guidelines work? I am not aware of a comprehensive review of the system. Trust us; we’re doctors.
Although the bone infection recommendations discussed in the original post do not appear to be an example of this, I want to make the point that sometimes guidelines cannot be based solely on best practices even when the evidence supporting those practices is very strong. Unfortunately, in the US, we live in a highly unequal health care system, and sometimes the clearly best practice requires resources that are not accessible to all. Rural health care facilities, in particular, may not have the necessary personnel, equipment, or technology to provide best practice care in some situations, so guidelines must also accommodate second- or third-best practices in such situations, at least until such time as those resources become universally available.