What’s in a medical guideline?

Maybe less than you think.

By Howard Wolinsky

It seems that guidelines from major medical groups are made to be broken. This is new news for me.

We patients apparently take them more seriously than the sheriffs and undersheriffs of medicine who apply them — often loosely, somewhat based on what the patient market is saying.

From a patient’s point of view, guidelines from major medical organizations sound like the law from on high. It’s true in men on active surveillance (AS) — close monitoring — of very low-risk, low-risk, and intermediate-risk cancers, and likely is true in some other cancers as well.

So it’s no wonder when we are confused and worried about the fact that men on AS may seem, on the surface, to be on the same path yet we receive conflicting advice from our doctors on what to do and when to do it.

A new study found that 70% of patients receive follow-up care that is not guideline-adherent, characterized by insufficient or excessive surveillance testing, potentially diminishing AS effectiveness and contributing to poor patient outcomes. More on the study below.

Opinions on AS vary between patients, doctors, countries. When we compare notes, this is obvious.

Some doctors view AS as a way to avoid radical surgery or radiation and the risks that go with them including impotence and incontinence, Others see AS as a way to defer treatment, especially in low-risk (versus very low-risk) prostate cancers and intermediate-risk prostate cancer.

Intervals between biopsies may vary. Men on AS typically dread these exams. and, More often not in the U.S., they done through the rectum or the “rear passage” as UK docs say, putting us at risk for potentially deadly and disabling sepsis as well as other infections in the anatomic neighborhood.

Some doctors say doing the biopsy through the perineum — the area between the anus and the testicles — absolutely prevents sepsis. Others say the transrectal route can be done safely and avoid sepsis risk. Period.

Intervals between biopsies vary. When I started on this path in 2010, annual transrectal biopsies were the most common approach, and men like me got little warning about the risks of infection.

The guidelines from the American Urological Association, the professional organization for urologists, are under review now. But in recent years, they recommended transrectal biopsies as the preferred approach while the European Association of Urology last year made transperineal biopsies the preferred approach.

These guidelines remain a matter of debate — in the U.S. anyway.

There also is debate over how often to do biopsies. When I started, I had an annual biopsy for the first four years, then my urologist said “we know your prostate pretty well” and so I went on a three-year “biopsy vacation.”

I switched doctors (for a variety of reasons) and my new doctor insisted on a baseline biopsy and MRI — neither of which found evidence for any prostate cancer. [There is debate over whether I underwent a remission. Some say that’s impossible low-risk prostate cancer can only tickle the immune system at most. But others like Laurence Klotz, MD, the pioneering urologist who named AS and helped develop it, think not that much is known and that remission is possible. https://www.medpagetoday.com/special-reports/apatientsjourney/81775

I pointed out to my new urologist that Klotz had his patients wait as long as four to five years between biopsies.

Why can’t I? A few years ago, I told Brian Helfand, MD, PhD, division chief, urology at NorthShore, and clinical associate professor, University of Chicago, my urologist since February 2016 at NorthShore University HealthSystem outside Chicago, that patients are going to revolt against the frequency of biopsies. He insisted the biopsy was his best tool — so tough.

However, to his credit, he has become more flexible in his approach — at least with me. It will be six years since my last biopsy and MRI in July 2016.

And we’re holding steady — maybe in part because COVID-19 has kept me away from doctor’s offices (as well as grocery stores). I have stayed current with my PSA testing and everything appears to be stable.

Eventually, maybe this year, I’ll go in for an exam, and I’ll see what he recommends then. He has suggested I may, at age 74, be done with biopsies. (Several other doctors have recommended this for me. Note: It may be different for you, which is part of the discussion here. Different strokes …

Now, a new study suggests that a whopping 70% of urologists don’t adhere closely to guidelines.

The guidelines from the National Comprehensive Cancer Network (NCCN) are not followed in 70% of cases, researchers reported in September in the Journal of Clinical Oncology.

Sarah Birken, PhD, of Wake Forest School of Medicine in Winston-Salem, North Carolina, and Soohyun Hwang, a doctoral candidate at the University of North Carolina in Chapel Hill, conducted in-depth interviews with 13 U.S. urologists. They presented their findings at ASCO Quality Care Symposium.

Sarah Birken, PhD

They found that AS was “characterized by insufficient or excessive surveillance testing, potentially diminishing active surveillance effectiveness and contributing to poor patient outcomes.”

Sounds scary, right. Wait a minute. Doctors will say to remain calm.

(, right?)

The researchers added: “All urologists [interviewed] referred to the NCCN guideline; however, most urologists adapted the guidelines to their needs and/or comfort level (e.g., following a subset of recommendations; adapting the interval/frequency of serial tests).”

Doctor comfort is a thing?

Birken told me: “As with any treatment or evaluation approach, some variation is to be expected and is desirable. What the MedPage article leaves out (necessarily, since they’re distilling an entire study to a snippet) is that, in the absence of universal ‘rules’, as Dr. Hwang put it, we use NCCN guidelines as a proxy for recommended practice. This approach is intended to account for evidence that, as much as some variation is expected/desirable, there is a lot of variation in all kinds of clinical practice that is unnecessary and in fact harmful. For example, there is general consensus on the fact that AS follow-up should involve serial testing (e.g., PSA, prostate exam, biopsy), but we know that does not happen often enough in practice.”

She added: “At the end of the day, we’re all human trying to do the best with the knowledge we have. It takes a village to improve care and outcomes!”

Doctors recommend different intervals between biopsies. Some of us patients may have biopsies annually, every two years, and even every four to five years. There are similar issues with MRIs.

Here’s what the NCCN recommends: PSAs no more than every six months unless clinically indicated; DREs [Digital Rectal Exams] no more than every 12 months unless clinically indicated; repeat prostate biopsies no more than every 12 months unless clinically indicated. Repeat molecular tumor analysis is discouraged during AS. [ https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1459]

In fact, I have found in talking to many patients on AS that different doctors recommend different intervals for different patients.

Why the variation? Patients are raising concerns about infection risks for biopsies, for example. And doctors may be responding to those concerns, the study reported.

The researchers told MedPage: “At the provider level, the biggest reason for variation of adherence came from the fact that it is difficult to have a cookie-cutter approach for everyone. Based on the bigger umbrella of guidelines, providers adapted active surveillance follow-up care considering patients’ objective risk factors (e.g., age, surveillance period) and patients’ preferences (e.g., discomfort with biopsy, concerns of infection). Individual perspectives and knowledge of the providers on the biopsy and MRI also influenced the way they provide AS follow-up care.” [Emphasis added.]

Patients may be surprised or, like me, shocked. But doctors take these variations in stride, per their comfort levels.

Helfand said: “This study doesn’t surprise me, but it is somewhat sensationalized. Meaning, that there are no universal ‘rules’ that dictate the frequency or manner by which AS should be offered. In fact, more and more I believe that (urologists) have to cater to the patient’s co-morbidities and risks. In addition, they need to get multi-parametric data (biomarkers, imaging, pathology, genomics) to better guide a patient’s surveillance course. Most advanced ‘algorithms’ haven’t been written. Therefore, [it’s] not surprising that many physicians don’t follow these guidelines right now and go based upon their comfort level.”

Brian Helfand, MD, PhD, gloves up for my DRE.

He added: “Some men need to be more closely surveilled than others. Noncompliance by patients can lead to watchful waiting strategies which are not suitable for most.”

I asked Edward “Ted” Schaeffer, MD, PhD, chair of the prostate cancer panel at NCCN about variation. He said it is simply part of the “art of medicine.”

[He also is chair of the Department of Urology Feinberg School of Medicine and Program Director of the Genitourinary Oncology Program at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. His patients have included actors, Robert De Niro and Ben Stiller. https://www.medpagetoday.com/special-reports/apatientsjourney/60753]

Schaeffer suggested that guidelines simply are that — ”guide, guardrail, etc.”

Patients beware: Guidelines seem to be moving targets. Sometimes moving at the speed of the internet.

Back in September, his panel at NCCN recommended that AS no longer be the “preferred’ approach to low-risk prostate cancer, but should be on a par with surgery and radiation. [https://www.medpagetoday.com/special-reports/apatientsjourney/94840] Only a single lonely voice on the panel opposed the guideline change. Thank you, Todd Morgan, MD, of the University of Michigan. (Go blue.)

Matthew Cooperberg, MD, MPH, a urologist at the University of California, San Francisco, led a counterattack against the guideline change through Twitter. Doctors like him worked hard for a quarter-century to win acceptance of AS as the standard of care and fought against the change in the guideline. Patient groups also attacked the new NCCN guideline for low-risk prostate cancer.

(Note: NCCN never changed its position on very-low risk prostate cancer.)

AS advocates — doctors and patients alike — pushed back and NCCN reversed its position in late November. [https://www.medpagetoday.com/urology/prostatecancer/95949]

As to the new study, NCCN’s Schaeffer said: “Look at the footnote we added for the revised AS guideline. We say it there perfectly. Something like ‘panel recognized that there is heterogeneity within patients….’”

In other words,

Howard Wolinsky is a Chicago-based medical journalist. He has been on AS since December 2010. He writes “A Patient’s Journey” blog on low-risk prostate cancer for MedPageToday. See his columns at MedPage Today: https://www.medpagetoday.com/special-reports/apatientsjourney He also now covers primary care for Medscape and helped found the advocacy and support groups for AS from Active Surveillance Patients International (aspatients.org) and the AnCan Virtual Support Group for AS (ancan.org).

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Howard Wolinsky is a Chicago-based medical writer. He has been nominated twice for the Pulitzer Prize for articles for the Chicago Sun-Times.

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Howard Wolinsky

Howard Wolinsky is a Chicago-based medical writer. He has been nominated twice for the Pulitzer Prize for articles for the Chicago Sun-Times.