USPSTF has modified research plan regarding risks/benefits of PSA screening

Regular readers of this blog news site will be well aware that the US Preventive Services Task Force (USPSTF) is currently re-examining its recommendations as to the use of PSA testing as a means to screen for risk of prostate cancer.

We have just been informed that the USPSTF has posted a revised and final research plan related to the value of PSA testing as a screening mechanism for risk of prostate cancer and we are pleased to see that the revised plan appears to have taken account of several of the issues that Prostate Cancer International and other commentators made in response to the initial research plan near the end of last year.

In particular, the revised plan now appears to take significant note of issues affecting the known risk levels of differing categories of patients for a diagnosis of prostate cancer and the degree to which that baseline risk level may impact the value of regular screening for subsets of patients. This was a very critical issue for Prostate Cancer International, and for some other commentators too.

The new plan also carefully separates the potential harms of PSA testing from the harms related to biopsy and to specific forms of management as a consequence of a positive prostate biopsy because of an elevated PSA result … another key issue for many commentators on the initial plan.

This new research plan will be used as a guide for a systematic review of the available evidence by researchers at an established and independent “evidence-based practice” research center. The resulting evidence review will then be used by the USPSTF as the basis for a new USPSTF set of recommendations on this topic.

In all fairness to the USPSTF, the panel appears to have listened carefully and attentively to many of the criticisms of the initial research plan that had been put forward, and appears to have been willing to make significant adaptations to the research plan in order to address these concerns. Whether this will help to lead to significant modifications to the final recommendations is a question that we aren’t in a position to answer. However, The “New” Prostate Cancer InfoLink and Prostate Cancer International are now much more comfortable that USPSTF is looking at the issue through a much better set of glasses!

8 Responses

  1. Thanks so much for this report! I had called the Task Force once and e-mailed once to try to find out if they were really taking comments to heart, but was told only that the research plan was still in process.

    I like some of the important changes I’m seeing, but am looking for others that were needed. Will study this.

  2. No one is suggesting that the revised research plan is “perfect” (from anyone’s perspective). However, it is a great deal better than it was!


    I have now had time to do an initial read through the plan. The Task Force has indeed made substantial and much needed progress from the clearly inadequate initial plan, but much more improvement is needed! I have already outlined some points and hope to post shortly.

    While this plan has been issued as “final”, we must not settle for that! I’ll just mention one critical failure: the plan fails to include the patient’s empowerment status regarding active surveillance at numerous key points in the analysis! If the Task Force remains blind to that, I am convinced they will fail again.

    Here is another critical concern: the last sentence reads: “The USPSTF made no major changes to the scope of the review or the approach to synthesizing the evidence.” I fear that means they once again have not considered and found a way to tap adequate expertise in prostate cancer. This was a gross failing of the previous Task Force, as most of us probably know. I have no doubt I was just one among many of us who pointed that out specifically in recommended revisions to the research plan, and the apparent failure to change their approach suggests continued stubbornness on the part of the Task Force. While the previous group that blundered so badly appeared to include some highly talented and expert doctors and health professionals, their expertise clearly did not extend to prostate cancer, making them incompetent for their chosen role of assessing the effectiveness of screening. I have some hope this group will see the light and remedy this critical deficiency.


    Those of us who follow research on the New Prostate Cancer InfoLink are well aware that reference 2 below, the US PLCO trial, has fallen into critically serious disrepute as evidence regarding the value of screening versus no screening, primarily because there was heavy screening in both groups, but also due to some other serious issues.

    “2. Andriole GL, Crawford ED, Grubb RL 3rd, Buys SS, Chia D, Church TR, et al. Mortality results from a randomized prostate-cancer screening trial. N Engl J Med. 2009;360(13):1310-9.”

    We are also keenly aware that two major updates have been published regarding reference 3, the main publication of initial results from the European Randomized Study for Screening for Prostate Cancer, known as the ERSPC.

    “3. Schroder FH, Hugosson J, Roobol MJ, Tammela TL, Ciatto S, Nelen V, et al. Screening and prostate-cancer mortality in a randomized European study. N Engl J Med. 2009;360(13):1320-8.”

    Those updates document that the number of screenings needed to save a life has plunged with just four additional years of follow-up, despite rather porous screening and some other issues that under-emphasize the true impact of screening, making it highly likely that the true favorable impact has been underestimated. Those updates also document a shift from a “significant” favorable impact for screening to a “substantial” favorable impact. Several sub-studies have strongly suggested even more favorable impact when key issues are considered, such as “non-compliance” and “contamination”. Moreover, the “13 year” update for the first time reported that follow-up since diagnosis in both arms was very short in terms of the total fuse for our disease: just 6.4 years in the screening arm and 4.3 years in the non-screening arm.

    I am at a loss in understanding why the Task Force would still cite the PLCO study, which clearly has limited relevance to the key matters, and why they would cite the now obsolete results from the ERSPC. Yes, those initial results are important to understand the vitally important trend as follow-up becomes more mature, but as a stand-alone snapshot the results are highly misleading.

    It’s a near certainty that many of us commented on these critical matters, yet the Task Force is not reassuring us that they received the message. Most disturbing!

    Any reassuring insights or guesses about sound reason for their reference choices?

  5. Sitemaster,

    I’m reminded of Joe E. Brown’s line at the end of the movie “Some Like It Hot”: “Nobody’s perfect!” I do see that the USPSTF research plan fits what is needed at least as well as Jack Lemmon’s character fit Joe E. Brown’s characters matrimonial requirements.

  6. Dear Jim:

    They mention these studies because they are the only two studies that have ever been designed and conducted to evaluate the possible risks and benefits of PSA screening. We are going to need to be patient and see what the research group says about the most recent data from these studies as part of their report to the USPSTF. You are passing judgment based on the last evaluation. Some of us are withholding judgment in hopes that the USPSTF will “do better” this time around — although I will tell you frankly that I am not expecting any type of enthusiastic endorsement for mass, frequent PSA testing, nor to I believe that that is justifiable.

  7. Response to May 1 at 8:12 am – whether to settle for the Task Force’s “final plan” re screening for prostate cancer

    Hi Sitemaster,

    Thanks for your thoughts, as always.

    The “patience” route may be productive, but I am going to try again, but persistently this time, to interact with the Task Force about weak points in their “final plan”. I am contemplating working with my US congressman and perhaps also senators to motivate the Task Force to reopen work on their research plan. There is an important government connection, which is that the Affordable Care and Patient Protection Act links insurance coverage of screenings to recommendations of the Task Force. Congress needs to address situations in which the Task Force is demonstrating incompetence for what is, in effect, a regulatory role.

    Based on the Task Force’s failure to address a number of rather obvious key flaws in their initial draft plan, and their woefully botched job last time around, I am at this point pessimistic about their ability to do a competent job. Among many discouraging points, their inclusion of the PLCO study is particularly telling, as it is of no value at all in discerning the value of wise screening versus no screening. Though PLCO does have some useful information about ancillary issues, such as side effects, that does not warrant the prominence given the study in the “final” research plan, prominence which leads me to believe the Task Force is still wearing blinders and has not tapped adequate expertise in prostate cancer.

    I was at the point of writing a book about the Task Force and prostate cancer screening when the initial plan and request for comments was published. I already had a title, a co-author I would like to recruit, and many points to cover. (Actually, I would like to recruit two co-authors.) I deferred the effort when it initially looked like the current Task Force might be open to much needed input and sufficiently competent. Now I will resume work, hoping that the Task Force takes off its blinders and sees the light, which would spare me the time and effort needed for the book. If that book is published, the Task Force will be humiliated, and I have no desire to do that if it is not necessary to protect American men and their loved ones from what to me is a form of medical manslaughter, albeit legal.

    You and I see eye-to-eye on mass screening. You wrote above: “… although I will tell you frankly that I am not expecting any type of enthusiastic endorsement for mass, frequent PSA testing, nor to I believe that that is justifiable.” My comments to the Task Force on their initial plan included this as my position and suggested ultimate recommendation: “The US Preventive Services Task Force recommends that informed screening, where intervals are tailored to individuals and active surveillance is emphasized as a key approach if prostate cancer is diagnosed and is characterized as ‘low risk,’ is of net benefit for men with a life expectancy of at least 10 years. The Task Force also recommends that uninformed screening is likely to lead to more harm than benefit for most men.”

  8. Jim:

    Good luck with getting anyone in Congress to do anything meaningful in the next 8 months!


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