Informed Consent Form for a PSA test

In view of the potential approval of the latest USPSTF recommendation “as is”, prostate cancer awareness for uninformed men has presently become a more important priority than ever. Creating such informed consent form for a test is difficult for several reasons. The form needs to be concise and written in understandable language for men to be able to decide to be tested or not. What follows is a work in process document and support documentation should be added. I am just trying to keep it as short and readable as possible.


Testing for prostate cancer Pros and Cons

Patient's information for an informed consent decision: PSA/DRE testing for prostate cancer

Read this information carefully before deciding whether to be tested or not.
Prostate-specific antigen (PSA) is a blood test. Blood will be drawn from your arm and submitted for chemical analysis. Results will be compared with a normal range, adjusted for age.

Digital Rectal Examination (DRE) is a procedure by which the physician introduces his gloved finger in your rectum in order to "feel" the prostate for any irregularities.

1. At present, doctors are divided over the advisability of testing with PSA and DRE in an asymptomatic man. As a result, each man should be informed of the potential risks and benefits before deciding if he wants to be tested or not. Prostate cancer remains the second cause of cancer death in men.

2. The decision about having the PSA and DRE depends on each man's goals, fears and willingness to accept risk. There is risk in taking the test and detecting cancer and getting treated with potentially unpleasant side effects. There is also risk in deciding against the test, since prostate cancer has very few symptoms and the disease can be advanced and incurable before detected at a later point.

3. The disease is more prevalent in older men; men with a family history of the disease and for unknown reasons in African-American men.

4. The decision is yours. Learn as much as possible before deciding.

INFORMED CONSENT FORM

AGAINST TESTING STATEMENTS:

Studies that assess the value of testing with PSA and DRE have resulted in divergent results and the study that supports screening showed that many men have to be tested (and treated) to save one life. This can result in treating many who never might need treatment.

At present, there are few completed randomized clinical trials to demonstrate that testing with PSA and DRE can reduce a man's chances of dying or suffering from prostate cancer. There are studies in progress that demonstrate preliminary evidence that early detection and effective treatment can alter the natural course of the disease and improve survival.

Many men who have prostate cancer will die from other causes without suffering any effects from the disease. Therefore neither testing with PSA and DRE nor treatment is necessary or beneficial to them.

Current treatments may cause unpleasant side effects in some men. Incontinence and impotence in various degrees are among the most prevalent and sometimes difficult to overcome

Improving early detection is not a guarantee that cancer deaths will be prevented. No testing with PSA and DRE is the best way to maximize a man's quality of life, as long as you understand that the disease might continue to progress, ultimately demonstrate symptoms and could eventually, if you live long enough result in an advanced diagnosis.
Such symptoms of progression can impact the patient’s quality of life.

The biggest benefit of testing is in men with a life expectancy of 10 to 15 years. As men get older this benefit decreases.

The actual test (PSA/DRE) is usually harmless. If the results are abnormal, you might be offered a biopsy. This test can lead to detection of prostate cancer and further treatment complications.


PRO TESTING STATEMENTS:

Prostate cancer is a progressive disease with few symptoms and many times without any symptoms, so you could have prostate cancer without having symptoms.

The disease is more prevalent with advancing age. Men should be aware of this as early as possible to be able to make an informed decision. The age of increased risk is 50 for whites or 45 for blacks. Family history of prostate cancer or race such as African-American men are at higher risk to develop prostate cancer AND should be tested at age 40 or less.

Presently, 42% of men older than 50 years will have prostate cancer during their lifetime, 9.5% will have disease that causes problems and is considered clinically significant and 2.9% will die of the disease.

Prostate cancer contained within the prostate is potentially curable. Early-stage prostate cancer is usually contained within the prostate. Prostate cancer that has extended beyond the prostate, called advanced prostate cancer, is considered incurable at the present time.

At least two studies have demonstrated that early detection and effective treatment has resulted in a survival benefit by altering the natural course of the disease.

A blood test, called Prostate-Specific Antigen, - PSA - can detect prostate cancer. The value of this test is that by serial testing it can predict the incidence of cancer well ahead of the disease demonstrating clinical significance. PSA/DRE testing improves early detection of prostate cancer, especially in men without symptoms.

Since the inception of PSA and DRE use there has been a 40.0 % reduction in prostate cancer mortality between 1993 and 2005. This reduction in mortality remains unexplained.

The real value of the PSA/DRE test combination is to establish a baseline measurement and then do periodic measurements. If the measurements vary considerably from year to year, this warrants investigation (variation of 0.75 ng/ml or more in PSA).

Recent studies supported the notion that if men, starting at age 40, get tested with PSA every 5 years, these tests should be able to project a 25-year risk analysis for diagnosis of prostate cancer and/or clinically significant prostate cancer. This analysis should project the timeliness of PSA testing based on test results. That is some men will need to be tested periodically while others will not based on risk

Without PSA and DRE testing, a high percentage of men will be diagnosed with advanced prostate cancer, incurable disease, rather than being diagnosed earlier, with potentially curable disease, as it was the case before the commercialization of the PSA test.

I, ___(signature)______________________ have read this information and after evaluation have decided to: Defer test ( ) Accept test ( )


This material has been prepared with the available information current at this time. The intent is to motivate men to understand the benefit/risk value of PSA/DRE testing and decide for or against the test. A form created by Dr. Gerald Chodak years ago was used as the base for this document.

Prepared by Ralph Valle, Prostate Cancer Survivor. Phoenix, Arizona.

Ralph,
Well thought out. But I'd like to add an additional line item in the "For" section. Hopefully you can rewrite it better than I can say it.
The DRE is subjective and dependent upon the skill of the doctor.
My GP gave me a DRE and did not notice anything significant. "A little firmness on one side." (Remember, I had just had a PSA come back at 17!). I went to the Uro and he did the same exam and he called it "Serious". He also identified "potential EPE" and ordered a biopsy ASAP. It showed 7 positive out of 12 with up to 70%. Surgery Pathology showed EPE, PNI, ...

So, two docs, two totally different diagnoses within 1 weeks of each other. Who was right? The Uro, of course. He has more experience.

The PSA test, even with its problems, is objective. With my "normal" DREs, no symptoms, no problems, no history of PCa, had I relied only upon my GP's limited DRE skills, I'd be dead.

How do you word that into an informed consent line item? Objective vs Subjective.
Jeff

PS the DRE performed by my GP was not uncomfortable at all. The DRE by the Uro caused me to ejaculate on the table.
Two DREs from two Doc. It was a totally different animal with totally different results. Further proof of subjectivity.

I agree with Ziggy.  Also, the website http://www.cancer.org/acs/groups/cid/documents/webcontent/003014-pdf.pdf

discusses consent for cancer "treatments" which require informed consent, and distinguishes those from "simple consent" to things like blood testing.  I've been looking around on the internet and have been unable to find any "informed consent" for blood testing, other than when the blood is to be used in a study, or when it involves HIV testing.. 

PSA testing is simply a blood test.  If its role needs to be better explained to a patient, that would likely happen verbally between the doctor and the patient.  I just can't envision signing an informed consent for a simple blood draw.

I can't honestly say I've ever thoroughly read the consent form, even before my surgery, and I doubt men would take the time to study a consent form before a simple blood draw.

I think we're getting carried away with this.  My nurse wife says their consent form for HIV testing is about three lines long.

 

The form is great but way too wordy in my opinion. After that first paragraph you will lose a lot of attention. I saw Chodak's original document and thought that that one was too wordy.

Guys, Ralph is exactly the kind of active advocate that can get this to the right resources. He is a very respected participant in the major PCa groups in the US and he is a past Harry Pinchot award winner recognizing his outstanding efforts for men through nearly 20 years of effort. Don't take this effort too lightly. I support him in this effort.

For many men this stuff isn't taken seriously enough. That is a problem. I believe it's incumbent on the past patients to present what they would like to see done better for future patients. If you don't want to participate in the discussion then don't. But this effort needs to be completed by November 9 which is the close date for the USPSTF comments on the draft recommendation. They may use it or not, but they will be thinking about another approach than just sweeping screening under the rug.

The more in conversation that this topic is, the more in awareness to potential or new patients is accomplished.

Clocknut,
You are correct about the consent forms being too much for a patient. I personally don't even remember mine. There needs to a simpler way to say that prostate cancer is two diseases, that knowledge of having the disease is commonly misunderstanding, and that not all patients that test positive for the disease are in need of treatment.

Ralph,
What do you think about recommending a "cooling off period" for all G3+3=6 patients in the form. In other words a general recommendation that says all G6 diagnoses should wait through 90-180 days of monitoring before active therapy should be performed? Putting something to that effect into a statement would help a patient find the time to learn more before acting on the "shocking" diagnosis. This would make patients think about why this is as opposed to having a complex form full of "maybe" situations.

Just thinking out loud...

Tony

Tony,
I know how difficult it is to create an unbiased, understandable, basic language and concise form that is targeted to men who have never had a PSA test and who have no idea about what prostate cancer is.

This form is like a Chinese restaurant menu. Select what is really important; change words that are too technical or obtuse; add important issues not included and last but not least do not dilute the effort if you think that this is not an important issue for the health of men.

Adding a "cooling off period" here is too much at this point. This is for a man to agree to be tested or not and not to decide what to do if diagnosed. It should be as simple as possible and to inform men about the benefits/risks of testing with PSA. Really more complicated that it seems and therefore more difficult to do.

For example. The primary issue with the USPSTF recommendation is to avoid over treatment. This is based on the premise that there is no survival benefit in treated patients. What is the truth or current reality? For some of us, the reduction in PCa mortality is an indication that the USPSTF recommendation has to be ignoring this data point and giving the two screening trials excessive weight in their decision. If early detection by PSA testing and treatments are not preventing deaths, what is causing the reduction in PCa mortality? It is mind boggling to say the least...

BTW, you give me more credit than deserved. I am just another cog on the wheel. Just a little one and by now a little worn out from too many years of battles. Still, this recommendation is so gross and so damaging that I felt compelled to battle some more and do something about it. I have already commented to the Task Force online.

This form is not going to change the recommendation. Physicians that diagnose and treat prostate cancer should all be fighting the effect that this recommendation will have. The same with all advocacy organizations. I am hoping for that although I am not holding my breath. The form, once developed and required for GPs to provide to men, should at least give uninformed men a chance to decide to be tested or not.

RalphV

I'm not diagreeing with anything that's been said in this thread, but let me ask again, can anyone provide an example of a blood test requiring "informed consent"? HiV testing does, but that's a special circumstance. Blood drawn to be used in clinical studies requires informed consent, but that again is a different circumstance.

I don't see where the PSA test requires special treatment in this regard. It's a blood test, as are tests for diabetes, cholesterol, and many other disorders.

I don't think the DRE requires "informed consent."

Certainly informed consent becomes an issue at the time of biopsy, where actual tissue is being taken from the patient, and after which significant life-altering decisions may have to made, and it's at that point that the patient needs to be thoroughly advised of the significance of his PSA results, treatment options, side effects, long-term survival rates, and so forth. That's where Ralph's comprehensive list that looks at both sides of the issues needs to be brought into play.

Clock,
One of the complaints given by those that oppose the PSA test is that it is given to men without letting them know. Since the USPSTF current recommendation is for GPs not to offer the test to men without symptoms, how will these men at risk because of age, family history or race would know that they are being denied the test. In other words, the decision is left to the physician. A required informed consent form would give the patient the right to chose. It is a convoluted way to prevent asymptomatic men from being denied a PSA. At the same time it provides a small amount of prostate cancer awareness at the appropriate age.

RalphV