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Prostate cancer and the PCP: the screening dilemma

2015; Wiley; Volume: 69; Issue: 12 Linguagem: Inglês

10.1111/ijcp.12745

1742-1241

Matt T. Rosenberg, Alexia Spring, E. David Crawford,

Bladder and Urothelial Cancer Treatments

The primary care provider (PCP) is in a difficult position with the myriad of recommendations regarding the screening of prostate cancer. New guidelines suggest that testing the general population lacks evidence whereas others state that it is appropriate in the correct patient. Universally all of the recommendations state that the PCP should involve the patient in a ‘shared decision process’ with whichever guideline they chose to follow. Regardless of the provider's belief or agreement with any of the guidelines one must question the feasibility of this process. Time and lack of urologic education are both obstacles for the PCP who is the gatekeeper for patient evaluation. In this perspective piece, the origin of the prostate-specific antigen (PSA) test is explored along with what the value truly means. The implementation of shared decision making is objectively reviewed as well as the ramifications of the entire process. In an endeavour to simplify screening for prostate cancer a logically based algorithm is offered. Eliminating the PSA as a screening test may be correct for some, but others may suffer and miss an opportunity for disease treatment. Understanding the limitations of what we know, embracing them and making a conscientious and intelligent decision is what we do as providers and how we can serve our patients best. The PCP is the gatekeeper for prostate cancer screening. The struggles facing the primary care provider (PCP) regarding the detection and treatment of prostate cancer are not new; they have just recently become more problematic. For the 20 some odd years that I have been working as a PCP this has never been straight forward. Who to screen? How often to screen? When to stop screening? Why is 4 a magic number? When did it change to 2.5? Why is a velocity of 0.75 so important, and why is a change of 0.5–1.0 (a doubling) less important than a change of 3.0–3.75 (a 25% increase)? What is PSA density? What is the value of percent free PSA, complex PSA, Phi, 4K, PCA3? All these numbers going through my head and on top of it I am thinking I could be sued for missing prostate cancer. If I am confused, and I studied Urology for 6 years before switching into primary care, what are my colleagues thinking? The American Urologic Association (AUA) did not make this easy. Their guidelines have never been especially clear. I recall sitting at the annual meeting in 2010 awaiting the new guidelines hoping it would be made more user friendly, whereas, in my opinion, they were made that much harder to follow. Ouch, I just want to know what is best for my patient. Now, fast forward to the USA Preventative Services Task Force (USPSTF) recommendations in 2012 and they did in fact make it easier. Don't screen! Sure, there are a few more details than just not screening at all, but this is really the current framework in the USA at the present time. So now, in 2015 we have a war of words and guidelines. The USPSTF has one view, the AUA has another and many other groups offer their various permutations. Unfortunately, this leaves the PCP in the middle, trying to figure out what to do. Actually, that is not true; the patient is in the middle. Whatever road we follow, or recommendation we make, the patient is the one who faces the consequences of the ultimate outcome. My objective in this perspective piece was not to point the finger of who is right and who is wrong but to be objective with the information that we have so my colleagues can make the best decision for the patient that trusts them to do so. With that in mind, let us start with the prostate cancer basics: Prevalence and Impact. Not only is prostate cancer the most common noncutaneous malignancy in males, but it also has one of the lowest percentage mortalities compared with other cancers. A significant dichotomy exists as the lifetime risk of a diagnosis of prostate cancer in a US male is 17% and the lifetime risk of dying of the disease is 3% 1. Age is a risk factor, as is race and family history. The prevalence is highest in African American men who also have a higher risk of mortality from prostate cancer. Caucasian males have the next highest risk and those of Asian descent have one of the lowest. The impact of prostate cancer is fairly obvious in that it can be fatal and even if you do not die of this disease there is a tremendous emotional toll. Enough said. Screening is the process of identifying apparently healthy people who may be at increased risk of a disease or condition. They can then be offered information, further tests and appropriate treatment to reduce their risk and/or any complications arising from the disease or condition 2. Historically, there are two ways to screen for prostate cancer, the digital rectal examination (DRE) and PSA blood test. The DRE assists in picking up cancers in the posterior peripheral zone of the prostate. DRE is simple and inexpensive but you cannot obviously feel the entire prostate with your finger. Some screening studies now omit the DRE. I tell my patients it is like examining one slice of an orange in order to evaluate the entire fruit. The PSA is actually the second blood test used in prostate cancer. The first was acid phosphatase and this was introduced in 1939, but it was not very sensitive in detecting early disease. PSA was discovered in 1970 and was the basis of the ‘rape test’ and was found to be elevated in men with prostate cancer in 1980. In 1986 the Food and Drug Administration (FDA) approved PSA to be used in monitoring prostate cancer recurrence and then in 1994 the lab was approved for screening in conjunction with the DRE. The key point here, and something to remember throughout this paper, is that PSA was never approved to be used alone. So, what is PSA? I have already explained that it stands for prostate specific antigen, which, in fact tells the real story. It is a laboratory value that is prostate-specific and elevations occur not only in cancer, but also with benign prostate hypertrophy (BPH), prostatitis and trauma. The most common cause for an elevated PSA is actually BPH. Despite the urban myth, it does not go up with sexual activity or a screening DRE. There are minor variations in levels, day to day or week to week, as well as variability in different assays. Certain medications have an effect on the PSA level, such as statins and 5-alpha reductase inhibitors. This point is very important to reiterate, PSA is not prostate cancer specific, and was never meant to be used as such. To say it is accurate in diagnosing any specific malady in tremendously misleading. In reality, the sensitivity is highest at low levels while the specificity is highest at elevated levels 3. It has always been important to emphasise to a patient that they could still have prostate cancer with a low PSA and have benign disease with a high value. The PSA has historically been best used as a tool in combination with other risk factors such as an abnormal DRE or family history 4. With the prior information as a primer, we should now ask about the historical result of prostate cancer screening. In the years following the introduction of PSA screening by the FDA, there was a 49% decline in mortality with prostate cancer 5. Some experts speculated that it was a direct result of earlier detection via screening, while others pointed to better therapy with radiation and surgery and overall better medical care, such as cholesterol treatment and control of hypertension. Some lauded earlier use of hormonal therapy and other attributed this to improved lifestyles. Some said it made no difference as we just found more patients with insignificant disease. This last reason, seemed to get the most attention and created plenty of controversy. The continued debate prompted two separate studies looking specifically at the PSA, one in the USA and the other in Europe. The project in the USA was part of the Prostate, Lung, Colorectal and Ovarian study 6. In the prostate arm of this study, they looked at 76,694 men who were either screened with yearly PSA or nothing at all. After 13 years of follow-up there was no mortality benefit for organised annual screening compared with opportunistic screening. The results have been hotly debated with the main complaint being that there were a large number of prescreened patients resulting in a contaminated control group. Other issues were with the single point cut off for the PSA value and that the length of follow-up was too short 7. To further the controversy, a review of the data by Crawford and D'Amico identified a benefit in men who were in good health 8. The European Randomised Study of Screening for Prostate Cancer included 182,000 men who were either screened with a PSA every 4 years (no DRE) or not 9. The results showed a 25% reduction in metastatic disease and a 20% reduction in mortality. They showed that 1055 men needed to be screened for 11 years to save one man from prostate cancer. These results were also debated with the critics noting that of the seven studies in five countries, only two showed benefit (Dutch and Swedish). Again the length of follow-up was questioned with the idea that over a longer period, more benefit would be seen. In a 2012 review of the data, Schröder et al. showed that after 8–10 years the mortality benefit of screening started to considerably separate from the control group, with this benefit increasing each year thereafter 10. As a result of the conflicting data presented by the European and American studies, things got really heated. There is one camp which states that we grossly over diagnose prostate cancer. They rightfully point out that 50% of the men that are found to have prostate cancer would not have symptoms in their lifetime and suffer needlessly. They become unnecessary patients and potentially have unpleasant outcomes such as erectile dysfunction, incontinence and other complications from biopsies, surgeries, radiation or chemotherapy. The opposing camp adamantly points out that if we don't screen then there are men who will be denied the opportunity for life saving intervention. Each side makes a convincing argument, which unfortunately leaves the treating provider not sure what to believe. After a thorough and conscientious review of the literature, and in an attempt to provide more direction, in 2012 the USPSTF gave the use of PSA screening in prostate cancer a ‘D’ recommendation. The guidance was that ‘Physicians should not order PSA screening unless they are prepared to engage in shared decision making that enables an informed choice by patients’ 11. For obvious reasons, urologists were taken aback by this and in 2013 the AUA put out a response in their updated guidelines. They stated that screening should still occur, but only for certain patients. The appropriate monitoring would be in patients 55–69 years of age or 70 years of age and older with a 10–15 year life expectancy. In patients less than 55 years of age they advocated use of an individualised approach. The screening interval may change depending on PSA and age. Similar to the USPSTF recommendations, they suggest using a shared decision-making approach 12. Other societies have advocated screening only certain age groups as well 13. We can start with understanding the population affected most by this decision which is, obviously, the patient. As the largest shareholder in medicine, and, in this case, the one with the prostate, they have the most to gain or lose. However, this population does not order the test and their knowledge of this may likely come from something they read or were told. There is certainly a myriad of men's health periodicals which give this attention but this may not get to the masses. What we do know is that these ‘masses’ probably have a PCP that they visit, maybe frequently and maybe not. When we look at who does the screening for prostate cancer a very interesting statistic comes into play. Historically, when we think prostate, we think urologist. However, the Urology community only orders 6.1% of the PSA tests and the PCP community (Internists and Family Medicine) orders 88.6% 14. The data therefore show us that the PCP is the gatekeeper of prostate cancer screening. To the likely dismay of the Urologist, the PCP community does not get their guideline instruction from the American Urological Association. 69% chose the USPSTF as compared with 4% choosing the AUA guidelines 15. This fact alone should serve as a wakeup call to the AUA to get more involved with their PCP peers in regards to education. The following recommendation is the guidance posted by the American Academy of Family Practice in regard to prostate cancer screening: Do not routinely screen for prostate cancer using a prostate-specific antigen (PSA) test or digital rectal exam. Physicians should not offer or order PSA screening unless they are prepared to engage in shared decision making that enables an informed choice by patients 16. If we get back to the largest shareholder, we can see that he is faced with conflicting data and is likely confused. Frankly speaking, the average patient is not reading medical journals; rather they are searching the Internet which is really the wild west of information. The Internet is lawless, not peer reviewed and you can find anything you want to justify or any preconceived notion you may have. There are trusted sites like the American Cancer Society giving the facts that 1 in 4 cancers diagnosed this year will be prostate cancer, and that there will be over 238,000 new cases diagnosed this year (2013 data). The Cleveland Clinic site states that 1 in 6 men will be diagnosed with prostate cancer in his life. Scary, maybe so, but then you have some fellow (not a healthcare provider) writing in Forbes Magazine that prostate examinations are no longer needed. As a doctor I am bothered, as a Urologist, in a previous life, I am shocked, but as a 52-year-old male, I am psyched that my prostate is now a no fly zone. Here is the challenge; the information is confusing in the most favourable of reviews. It is true that a significant percentage of males will get prostate cancer and it is also true that many of these men will have a cancer that will never do anything to them. However, in some cases, the cancer will do something bad so the decision to screen is not black and white…it is very, very grey. What our friend at Forbes Magazine failed to emphasise is that the recommendations state that the screening should, or should not, occur after shared decision making between the provider and the patient. This brings us to the next point: What is shared decision making? There are three tenets in this process. The first tenet is the provision of information that is balanced, evidence-based and discloses the harms and benefits of each option. The second is the elicitation of the patient's perspective, which includes asking about prior experiences, understanding and discussing concerns, as well as delineating preferences regarding screening options. The third, and final, tenet is guiding final decision making (without directing) 17. Understanding what goes into shared decision making is important and that leads to the next question of whether the process can be implemented according to design? There have been many studies on shared decision making including both observational, to see if it happens, as well as interventional, designed to facilitate the process. Han et al. looked at this from a patient perspective. He noted that shared decision making is an uncommon occurrence in PSA screening and that most PSA screening occurs with incomplete or no physician–patient discussion of its associated advantages, disadvantages and uncertainty 18. Most concerning was that the absence of shared decision making applies not only to PSA screening but even more so to non-screening. The author did note that men who reported being fully informed about advantages, disadvantages and uncertainty had a lower likelihood of undergoing high-intensity screening 18. However, this was not statistically significant. In a similar study Volk et al. looked at the process from a physician's perspective. He also noted a lack of shared decision making. He surmised that the variability in use of informed decision making can be attributed to beliefs about screening, including medical legal risk. He recommended that physicians who do not engage their patients in discussions about the potential harms and benefits of screening should consider changing their practice styles. The group concluded that the best way to facilitate the appropriate care would be with efforts to educate physicians about the shared decision-making process that should include countering the beliefs that perpetuate routine screening 19. Physician education was studied by other groups, however, the results were not what Volk et al. predicted. They found that, after receiving education on the topic, physicians still performed poorly in many aspects of counselling regarding prostate cancer screening, eliciting patients’ perspectives and in shared decision making. Interestingly, 90% of physicians self-reported that they took patients’ perspectives into account although objective data showed the opposite 17. In some cases, physicians were even compensated monetarily for the time they took to receive this education. They found that paid intervention physicians showed somewhat more shared decision making and tended to provide more neutral guidance, however, the effect did not reach significance. The authors concluded that intervention just for physicians may not be sufficient to optimise shared decision making, therefore the patient must also be educated independently. This pairing of patient and physician education was studied as well. Wilkes et al. designed a study based on getting the appropriate information to both parties prior to the patient visit. Information was provided via written material, the Internet and one-on-one counselling (counselling was for the patient only). This was a blind study as the patients and providers were not aware that the other had been educated in any fashion and what was uncovered was again disappointing for the researchers. There were no differences in standardised patient-reported indices of shared decision making. Most physicians (64%) lectured the patient about prostate cancer screening, rather than engaging in a two-way discussion (28%). There was a movement from a pro- screening bias towards neutral counselling about prostate cancer screening, but as stated earlier, this did not reach statistical significance 20. The natural question at this junction is whether this was a surprise or not? With all the efforts, the education and even the money given to the providers, how did this fail? What went wrong? The answer can be found historically. In a recent paper, Hoffman et al. noted that shared decision making has failed in other diseases as well. This list of disappointments includes breast cancer and colorectal cancer in both men and women, a true example that past performance predicts future performance 21. Maybe there are some very intelligent researchers or bureaucrats that believe if we keep pushing this idea of shared decision making it will work, but again, doesn't history tend to repeat itself and shouldn't we learn from our past? We can speculate on the many reasons that shared decision making did not work but I just need to mention one. Time! A colleague of mine predicted that it would take 23 min for him to adequately engage a patient in the shared decision process required in this discussion on prostate cancer, and he is a urologic oncologist! Before we speculate on why shared decision making has not taken hold, it is worthwhile to review the effects of USPSTF recommendations. In other words, what impact have the recommendations had on screening? Cohn et al., looked at screening changes pre and post-recommendation. When stratified by age he found a statistically significant decrease in the 40–49 year old range, as well as in 50–59 and 70–79. Only in 60–69 age group was the decrease not significant 22. What was very interesting was what they found in individual physician screening practices when specifically reviewing family medicine and internal medicine. Whereas the number of providers was low (52 in family medicine and 85 in internal medicine) the results pointed to the lack of clarity on what would be the best route to follow. Screening did decrease 25% in family medicine and 38.8% of internal medicine; however, it increased in 11.5% and 23.5% and had no change in 63.5% and 47.4%, respectively. It is unclear if change occurred or confusion reigned. In October of 2014, there was an interesting paper presented at the Western Section of the AUA looking at screening changes with the recommendations. They found that the overall testing rate prerecommendation was 14% in men over 40 years of age which then dropped to 7% after May 2012 (p < 0.0001) 23. Neither study mentioned whether shared decision making occurred or if providers just reacted blindly to the guidelines. It is fair to state at this juncture that the implementation of shared decision making has failed, but now it should be asked if this is a problem. There are three perspectives that we should consider: The patient, the PCP and the specialist. We can start with the patient. As previously mentioned, the patient is getting mixed messages and certainly may be resistant to any medical intervention and is happy to avoid any if possible. There is a fascinating paper by Cantor et al. looking at patient preference when it comes to screening. They acknowledged that there may be comfort in not screening when indications are not completely black or white, however this is outweighed by knowing that one is normal after screening regardless of indications. In other words, there is a significant quality of life benefit gained through screening and it is strongly supported by patients. From a patient perspective, the fear of the unknown is superseded by knowing they are disease free 24-26. Maybe a personal anecdote is appropriate here. I recently turned to the magical age that a colonoscopy was indicated. Of course I did not want to have it, who does? I am a doctor with no family history, so I know better, right? Wrong! I was just apprehensive. I thought about it frequently and kept up the rationalisation. After putting it off for 12 months I had the procedure and was cleared for 10 years. Immediate relief and I have not thought about it since. Again, we are scared of the unknown, but much more content when we know things are normal. There was another intriguing study done by Rychatnik et al. in Australia. They specifically took on the prostate cancer screening debate and presented it to patients in a jury format. The patients had extensive training on the disease, as well as the pros and cons of screening, by numerous specialists and were asked to decide (as a jury) what the ‘right’ answer was. They agreed that the data were questionable enough that the government should not focus on a public campaign or widespread screening and that efforts should be made to better educate general practitioners. When asked if they should have access to the test, 45% said no but 55% said they definitely would want the test or would consider it 27. This again shows that patient preference is paramount to the decision process and, as a group, there is more comfort in knowing we are normal than speculating. What about the perspective of the PCP? Let us start with the fact that the training of the PCP in regard to urological issues is minimal at best. There is no residency requirement for urologic training according to American Board of Internal Medicine and only a suggestion of exposure with the Family Practice Boards. As a frequent lecturer at PCP meetings, I always ask the audience to identify themselves if they spent time in training in a urology clinic and I am continually amazed at the low percentage of hands that go up. In a conversation with a colleague, he told me that this educational gap can easily result in the ‘Goldilocks Effect’; when too much information or too little information results in providers adopting a ‘screen all’ or a ‘screen none’ practice. In regards to prostate cancer the concern is that the PCP, who has a lacking of urologic education, screens every male or none at all. Unfortunately, neither of those tactics are correct. What is needed, according to the USPSTF, is a conscientious and thorough conversation with each and every patient, regardless of the time involved. If we dig a little deeper into the mind of the PCP, we can also imagine the internal debate that occurs when considering whether to screen or not to screen. Why should screening occur? Liability is certainly a reason, and so is patient request or uncertainty regarding the whole process. Reasons not to screen are led off by the current guidelines, but liability and uncertainly could also have an effect 28. The wild card here is future quality measures and this one makes me quite nervous. In primary care, we are now given a report card, and reimbursed, by how many of our patients smoke, how many are overweight, is their blood pressure controlled, did they get their flu shot, how often did they use the ER, did we order too many radiological images, to name just a few. My guess is that we may, in the future, be penalised for too high a percentage of PSA tests. True, some may believe that this is Orwellian in nature but is this not what the earlier mentioned studies hinted at? They all seemed to ask how we get providers to avoid this ‘unnecessary test’, as proclaimed by the USPSTF. In what I have interpreted as a relatively frightening study, Wilkes et al. gathered a group of providers and lay people together to try and figure out how to get providers to markedly limit or stop prostate cancer screening. In the Journal of General Internal Medicine, they presented their findings and boldly stated their recommendations. They said that we must empower the patient, that we must tailor the message to their cultural background and that we must assess and manipulate their readiness to adopt this position by organising small group forums, previsit phone calls and celebrity interaction 29. As I was reading this, I was imagining a Super Bowl Sunday commercial with a Hall of Fame linebacker holding a football telling patients to ‘Just Say No to Prostate Exams’. Bottom line is that this whole process is pitting the PCP against patient care and trust. We should now look at the perspective of the urologist and they seem to be fairly upset about this whole thing. I do not believe anyone will contest that the prostate is the domain of the urologist, as it is pretty much the centre of their universe, and they have publicly disagreed with the USPSTF recommendations. So here you have the leading national society of prostate probing providers vs. the USPSTF committee on prostate cancer screening. This task force included a mix of three pediatricians, four family doctors, two gynaecologists/obstetricians, two nurses, one public health specialist, six internists and 0 urologists. As genuine specialists in the field, the urologists believe they should be setting the gold standard in prostate cancer screening and treatment. To be fair, we should extend the ‘gold standard’ status to anyone focusing his or her practice on the prostate. What the specialists worry about is what if the USPSTF is wrong, what if death of PSA screening means we will return to a pre-PSA era when most men were diagnosed with advanced incurable disease? 30 Can we afford to be wrong, when the outcome is a death that could have been prevented? Let us now look objectively at the recommendations. I am not saying that the recommendations by the USPSTF are right or wrong as there are much smarter people in the world who can take on this battle. I do believe that some sort of correction was needed to eliminate the marked over diagnosis and treatment. Therefore, I would question whether the information for the patient is based on evidence and beyond dispute? The answer is no. Can the patient be presented with a clear framework for a decision? The answer is no. The primary care providers need a schema that is appropriate for their field. It cannot be assumed that the provider has detailed knowledge or the disease and the process should not require that the provider have more than a few minutes for the conversation 31. In fact, should we be having this conversation with everyone? Like any good family doctor, I believe in educating my patients. But I also recognise that my patients have many different backgrounds and levels of interest in the details of their care. Some want the minutia and others want just ‘whatever I would do for myself or my family’. What I hopefully have is their trust in me to do right by them. Think about the last time you went to have your car serviced, some folks want every little piece of information, and others just want the car to work. What we need to make prostate cancer screening make sense is the ability to make intelligent and personalised decisions. We need to avoid PSA tests in men who would have little to no gain by focusing on age and health and to not treat those who do not need treatment 32-34. Maybe we need an option to refer to high volume centres of excellence, which can advise us and the patient as to the best screening protocol for the lifetime of that individual patient. The USPSTF recommendation certainly has its critics but whether they are correct or not is actually not what is most important here. No matter the good intentions of the committee in its current form these recommendations cannot be readily implemented. What they state very clearly is that the well-educated provider develops (through