What's in a medical guideline? Maybe less than you might think.
But a cookie-cutter approach may not serve patients best, either.
(Editor’s note: Before I started this Substack newsletter in January 2022, I experimented with Medium.com. This was one of the last columns I wrote there. It was an eye-opener for me. I always thought medical guidelines were like the law. But it turns out that’s not the case, especially among urologists. I gave myself permission to reprint and update this Medium column from January 2022.)
By Howard Wolinsky
It seems that guidelines from major medical groups are made to be broken. We patients may take them more seriously than do the doctors who supposedly enforce them.
From a patient’s point of view, guidelines from major medical organizations sound like the law from on high. But we patients on Active Surveillance (AS) —close monitoring of low-risk or favorable intermediate-risk prostate cancer—often encounter discrepancies in guidelines, between medical societies within and between countries and individual urologists.
It can be like the Wild West out there in Active Surveillance-land. And individual doctors may make their own recommendations.
Take Digital Rectal Exams. Movember, the leading men’s health organizations based in Australia, is anti-DRE (I served on the guideline consensus committee) while American Urological Asociation conditionally recommends DRE.
Or take transperineal (TP) vs. transrectal (TR) prostate biopsy. The European Association of Urologists prefers TPs while AUA now gives equal weight to TP and TR. (I served as a consumer reviewer for AUA in 2023 and recommended against AUA’s position; they didn’t go far enough and should done what the Europeans did, IMHO, gave priority to TP.)
Plus, individual doctors may have their preferences regarding DREs and TPs, intervals between MRIs and biopsies, frequency of PSAs, targeted vs. non-targeted biopsies. You name it, and you can probably find equal and opposite guidelines.
It’s no wonder when we are confused about the fact that AS patients 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 and how long to follow guidelines.
I’m on AS lite now—which some doctors don’t consider AS at all since I have not had a MRI or biopsy in eight years—after previously being on annual biopsies. Now some urologists do biopsies every other year or every four to five years.
My urologist says I am on AS. Your doctor may say I’m on Watchful Waiting, a less-intense version of AS. I say I’m on passive-aggressive surveillance.
It’s dealer’s choice at the AS Casino Royale. Or , according to the 2003 movie, “Pirates of the Carribean,” More of a guideline than a rule.” meaning something is more of a recommendation than a strict requirement. It implies that there is room for interpretation, flexibility, and individual judgment.
Prostate cancer guidelines from the National Comprehensive Cancer Network (NCCN) are not followed in 70% of cases, North Carolina researchers reported in September 2021 in the Journal of Clinical Oncology.
Sarah Birken, PhD, of Wake Forest School of Medicine in Winston-Salem, North Carolina, and Soohyun Hwang, a PhD then at the University of North Carolina in Chapel Hill, conducted in-depth interviews with 13 U.S. urologists. The researchers presented their findings at ASCO Quality Care Symposium.
They found AS was “characterized by insufficient or excessive surveillance testing, potentially diminishing active surveillance effectiveness and contributing to poor patient outcomes.”
The researchers added: “All [interviewed] urologists 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).”
Birken told me: “As with any treatment or evaluation approach, some variation is to be expected and is desirable. … in the absence of universal ‘rules,’ … 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, she said, 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]
Still, the patient voice is starting to be heard. In Norway, the death of a single patient from a transrectal biopsy was front-page news. Patients there walked with their prostates—hearts and minds following— to urologists who offered TP.
Economist Adam Smith’s “invisible hand” in effect forced urologists to switch to transperineal as patients looked out after their self-interest in staying alive. The dead patient’s daughter and his urologist campaigned for change, and the European Association of Urologists designated transperineal biopsies as the preferred approach,
You can be a Super-Activist and sign my petition to phase out the transrectal biopsy at change.org: https://chng.it/7bQsWSfK
Why the variation in biopsies? Patients are raising concerns about infection risks for biopsies, for example. And doctors may be responding to those concerns, the study reported.
As a patient your whispers and shouts about your preferences such as the route of a biopsy are having an impact as patients are demanding transperineal biopsies, for example. Also, patients are demanding anesthesia to be knocked out during TPs, not the original intention with the procedure, which many leaders in the field thought should be done in urologist’s offices,
It isn’t just science talking, but the marketplace.
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.]
Brian Helfand, MD, PhD, chief of urology at NorthShore University HealthSystem, who has been my urologist for the past eight years, 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 last DRE. Doctors debate the value of 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.”
[Schaeffer 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. in Chicago. He has been the urologic oncologist to the stars,including Robert De Niro and Ben Stiller. https://www.medpagetoday.com/special-reports/apatientsjourney/60753]
Schaeffer suggested that guidelines simply are that—guides and guard rails.
Patients beware: Guidelines seem to be moving targets. Sometimes moving at the speed of the internet.
Back in September 2021, the NCCN prostate cancer panel 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, urology chief ar the University of Michigan Medicine. (Go Blue.)
Matthew Cooperberg, MD, MPH, a urologist at the University of California, San Francisco, led a counterattack against the guideline change through a Twitterstorm. Doctors like him and Morgan worked hard for a quarter-century to win acceptance of AS as the standard of care for low-risk patients and fought against the change in the guideline. Patient groups, including AnCan Foundation, Active Surveillance Patients International, and ZERO, joined together to fight the new NCCN guideline for low-risk prostate cancer.
It was a rare event for the advocates. But it worked. NCCN reversed its position in late November 2021 and reinstated AS as the preferred choice for low-risk patients: [https://www.medpagetoday.com/urology/prostatecancer/95949]
Again, your voice can be heard on these issues.
As to the Birken 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 meaning there are differences between patients…’”
So urologists and patients need to collaborate to find the best approaches based on individual situations.
For more information on the Wake Forest study, go to the Journal of Clinical Oncology: https://ascopubs.org/doi/abs/10.1200/JCO.2020.39.28_suppl.12 and to MedPage https://www.medpagetoday.com/reading-room/asco/prostate-cancer/96528
Clock’s ticking: The Active Surveillor’s ‘AS 25’ webinar coming up Jan. 4, 2025
By Howard Wolinsky
Paid subscribers and founding members to this newsletter get a free pass to “AS25,” (Active Surveillance 2025), a special program this newsletter is hosting noon-1:30 p.m., Saturday ,Jan. 4, 2025.
Please join us to hear about the latest developments in AS. Sign up ] for a paid subscription here:
I’ll take care of the rest.
Speakers include:
--Jonathan Epstein, MD, former chief pathologist at Johns Hopkins University School of Medicine, one of the world's leading pathologists. Epstein, now based in New York, will be making his first appearance before a patient audience in almost two years,
—Brian Helfand, MD, PhD, chief of urology at NorthShore University HealthSystem outside Chicago, an expert not only in prostate cancer but also in molecular biology.
—Christian Pavlovich, MD, who runs the Active Surveillance program at Johns Hopkins and recently co-authored a major study on diet.
—Timothy Showalter, MD, MPH, medical director of Artera AI, which has made news with its prostate test to help patients decide whether to go on AS.
This is the first program TheActiveSurveillor.com has hosted. I am providing a premium to paid subscribers and trying to keep this newsletter afloat.
If you can’t afford it, or have special circumstances (such as living in a country facing a banking boycott from the U.S. or are a “working” musician), let me know and we’ll work it out.
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I am curious about your experience about going on AS and the support you receives from your partner/spouse. Can you share your thoughts by answering the questionnaire here: https://docs.google.com/forms/d/e/1FAIpQLSfslJOsvi3wGiHJrtFcYey4Ntl8vsNBWiJ51cN8KAkIQ8xAtw/viewform