Guidelines - Friend or Foe?

[RadOncMegatron]

In my mailbox, I received the latest ACR journal picks and as always, Dr. Recht makes some great insights.

Here is what he says:

There is often very limited evidence, especially from randomized trials, for many important decisions faced in the clinic [1]. This is especially true for technical aspects of radiation therapy. Thus, panels tasked with creating clinical practice guidelines frequently must decide between stating that there are insufficient data to make concrete recommendations or making recommendations based on consensus among the members, realizing the lack of evidence but wanting to give "reasonable" answers to the perplexed. The first alternative tends to make the guideline sponsor and the intended audience unhappy. The second runs the risk that the imprimatur of a major professional society may give tentative recommendations excessive authority in the minds of practitioners or third parties (such as health insurers) by making it seem that a question is settled.

The two articles selected this month illustrate how different conclusions can arise from choosing between these philosophical and methodologic choices. Smith and colleagues updated the ASTRO whole-breast irradiation (WBI) guideline published in 2011 [2]. They also added recommendations regarding the use of a boost and many technical issues not discussed before. The second article, by myself and colleagues, was created in reaction to the ASTRO guideline. It reflects our belief that there was inadequate evidence for many recommendations and that the guideline did not consider plausible (and widely-used) alternative approaches.
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In my naivete, I thought that guidelines were good, but little did I know there is some push back on this through out medicine.

Article here : The Need to Systematically Evaluate Clinical Practice Guidelines

Dr. Vinay Prasad also has been calling attention to this issue and clinical trial problems in general. A little snippet can be found here: Vinay Prasad, MD, on 'Medical Reversal'

I am not taking a position nor endorsing any side (nor any of the above linked articles). I am just putting it out there for discussion.

Quite frankly we all feel the tension of ourselves being highly trained authorities that are tested to death and then having to further submit to guidelines we don't necessarily agree with. With that said, I'm sure we all love guidelines too b/c a lot of them are very good.

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[scarbrtj]

On the whole, foe. Guidelines (especially evidence-weak guidelines like Abe talks about) are a form of paternalism. A paternalism which most of us are too eager to accept. Over half of all published medical reports come with inappropriate amounts of "spin." Don't be naive and think that guidelines don't also. Guidelines and their sheen of authority allow Evicore to come forth with its own guidelines. That's a detriment to us all, no doubt.
EDIT: The TL;DR from Abe is basically "choice of WBI fractionation scheme and the overall treatment plan should be the prerogative of the treating physician" and not a situation of hypofractionation for all, and that conventional fractionation is still totally fine.

 

[medgator]

On the whole, foe. Guidelines (especially evidence-weak guidelines like Abe talks about) are a form of paternalism. A paternalism which most of us are too eager to accept. Over half of all published medical reports come with inappropriate amounts of "spin." Don't be naive and think that guidelines don't also. Guidelines and their sheen of authority allow Evicore to come forth with its own guidelines. That's a detriment to us all, no doubt.
EDIT: The TL;DR from Abe is basically "choice of WBI fractionation scheme and the overall treatment plan should be the prerogative of the treating physician" and not a situation of hypofractionation for all, and that conventional fractionation is still totally fine.

Cigna/evicore is the first to wonder why you aren't hypo-fractionating breast or prostate, but will still make you submit 3D vs imrt plan comparisons in stage III nsclc because the 0617 data clearly supporting imrt was a "secondary, unplanned" analysis (per my discussion with the p2p RO physician at evicore).

 

[Gfunk6]

While I agree that guidelines are generally a good idea - standardization makes the delivery of care safer and cost efficient - we need to be skeptical of the source of these guidelines and their motivation.

Insurance based guidelines are more designed to protect the conpany’s bottom line and they will not share their list of “experts” or their rationale.

Our practice has created physician based guidelines which were built by evidence and consensus. They are designed to streamline standard cases but are not meant to strongarm physicians with atypical patients.

 

[Krukenberg]

While I agree that guidelines are generally a good idea - standardization makes the delivery of care safer and cost efficient - we need to be skeptical of the source of these guidelines and their motivation.

Insurance based guidelines are more designed to protect the conpany’s bottom line and they will not share their list of “experts” or their rationale.

Our practice has created physician based guidelines which were built by evidence and consensus. They are designed to streamline standard cases but are not meant to strongarm physicians with atypical patients.

I think we’ve all seen and heard about older Rad Oncs not practicing standard of care. If the guidelines get them up to speed on today’s best evidence then it’s a good thing.

 

[evilbooyaa]

Overall guidelines are good - over-reliance on them is bad.

I think insurance-based guidelines are bad, but I think having specialty-created guidelines (like WBI, prostate hypofrac, etc.) are necessary for some amount of self-regulation.

 

[RickyScott]

Overall guidelines are good - over-reliance on them is bad.

I think insurance-based guidelines are bad, but I think having specialty-created guidelines (like WBI, prostate hypofrac, etc.) are necessary for some amount of self-regulation.

Agreed. If we dont create them, someone else will, and I am by no means a fan of ASTRO.

 

[scarbrtj]

but I think having specialty-created guidelines (like WBI, prostate hypofrac, etc.) are necessary for some amount of self-regulation.

I think the first ASTRO-created published guideline was around 2010. ASTRO started in 1958. That was about a half-century without any guideline afflatus; folks survived, patients were fine, doctors were OK, etc. There is no ASTRO guideline on rectal cancer, or testicular cancer, or plantar fasciitis. I was in residency when the first NCCN guidelines were published around 2000.... they were great, we loved 'em. In retrospect, be careful what you wish for. Like when Kirk asked, "What does God need with a starship," what does a person who goes to med school, trains in a specialty, succeeds in training and becomes board certified (and maintains their certification) need with a guideline? Wasn't that the whole purpose of the last decade and a half of his/her life? Guideline inculcation?

 

[evilbooyaa]

Yeah, but in 1958 there wasn't insurance trying to limit what people could do. Evolving times. If there aren't guidelines about utilization of resources, insurance companies will make them for us.

 

[Chartreuse Wombat]

As imperfect as guidelines are I think that this train has left the station. Increasingly payors judge treatment according to algorithms/guidelines. As pointed out, it is better that the physicians develop these rather than non-physicians.

 

[medgator]

Had 2 experiences with evicore this week.

First one was a lumpectomy patient where I had to treat nodes but the RN reviewer only wanted to approve 20fx until I pointed out I needed to treat nodes.

Second was an MD reviewer who insisted imrt isn't standard of care in lung patients with extensive N2 nodal disease and got really testy when I told her to read up on this before essentially forcing me to get a 3D vs imrt comparison.

They'll pick up guidelines that contain costs almost immediately like breast hypofx but point out the flaws in imrt data in locally advanced lung despite clear benefits in lung esophagus and cardiac dose.

Humana and cigna both seem to be the worst offenders and both use evicore.

 

[RickyScott]

Had 2 experiences with evicore this week.

First one was a lumpectomy patient where I had to treat nodes but the RN reviewer only wanted to approve 20fx until I pointed out I needed to treat nodes.

Second was an MD reviewer who insisted imrt isn't standard of care in lung patients with extensive N2 nodal disease and got really testy when I told her to read up on this before essentially forcing me to get a 3D vs imrt comparison.

They'll pick up guidelines that contain costs almost immediately like breast hypofx but point out the flaws in imrt data in locally advanced lung despite clear benefits in lung esophagus and cardiac dose.

Humana and cigna both seem to be the worst offenders and both use evicore.

Go through this every week. Problem is that it typically not up to reviewer, who may not have much discretion on their policy.

 

[medgator]

Go through this every week. Problem is that it typically not up to reviewer, who may not have much discretion on their policy.

You'd hope they would report back to their hire ups to get with the times, but no.

 

[Palex80]

Especially the field of palliative radiation therapy lacks alot of evidence. Some trials were clearly poorly designed / underpowered to detect any differences.

If we were to go "by the book" then I should no longer offer WBRT to NSCLC patients with brain mets, which were candidates for WBRT and non-stereotactic approaches. That's at least what QUARTZ showed.
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)30825-X/fulltext

Bone mets is another issue. I am seeing several colleagues offering SBRT for bone mets and sometimes doing it in patients with rather not very favorable prognosis. Why? Because we have dozens of Phase II trials on SBRT for bone mets but no randomized trials testing it against "standard" RT.

 

[medgator]

RN reviewer at Evicore's nasty cousin, AIM, is telling me that more than 30 fx in stage III nsclc is not medically necessary but she still wants a 3D vs IMRT comparison.

I like how they are picking and choosing whatever they want out of 0617 to contain costs and calling it "medically necessary."

Many of us never treat nsclc using either dose from that study (63-66 is my go to dose) and NCCN continues to endorse 60-70 Gy/30-35 fx... Can't wait for my next p2p conversation.

 

[OTN]

After 0617 came out I went to 30 fractions from 35 and never went back, so I really can't blame them there, to be honest. IMRT, though, really should be the standard of care after the same data was analyzed.

 

[seper]

If they are playing hardball, but your gut feeling to is to gently dose-escalate, I'd consider 2.1 Gy X 30 = 63 Gy. RTOG 1106 uses 2.2 Gy with chemo which is well tolerated.

RN reviewer at Evicore's nasty cousin, AIM, is telling me that more than 30 fx in stage III nsclc is not medically necessary but she still wants a 3D vs IMRT comparison.

I like how they are picking and choosing whatever they want out of 0617 to contain costs and calling it "medically necessary."

Many of us never treat nsclc using either dose from that study and NCCN continues to endorse 60-70 Gy/30-35 fx... Can't wait for my next p2p conversation.

 

[medgator]

If they are playing hardball, but your gut feeling to is to gently dose-escalate, I'd consider 2.1 Gy X 30 = 63 Gy. RTOG 1106 uses 2.2 Gy with chemo which is well tolerated.

I'll check that out, I'll still be a little gun shy if there is extensive N2/3 disease and the esophagus is going to get toasted.

Bottom line is that NCCN continues to endorse 60-70, and evicore/AIM is being disingenuous with how they use data/studies

 

[scarbrtj]

I'll check that out, I'll still be a little gun shy if there is extensive N2/3 disease and the esophagus is going to get toasted.

Bottom line is that NCCN continues to endorse 60-70, and evicore/AIM is being disingenuous with how they use data/studies

Remember when folks were saying 74/37 was good for NSCLC? That was part of the basis for RTOG 0617. It was a Carolina-ish dose. 80.5 Gy in 35 fx was another Carolina-ish dose (for Stage I). Anyways, all that meant to me, back in the halcyon days of dose-escalation for NSCLC, was that something like 73.5/35 should be similar to 74/37 (maybe better!) and so I gave 73.5/35 for a long time in Stage III. It's safe. Toasting the esophagus is never fun for patient or MD. As you know, esophageal doses vary widely patient-to-patient (because of PTV volumes/locations) despite the best planning one can do. But 63/30 is well within the BED realm of safety IMHO.
EDIT: And "disingenuous?" No. They're lying liars.