Reconciling Primary Care and Specialist Perspectives on Prostate Cancer Screening

Richard M. Hoffman; Michael J. Barry; Richard G. Roberts; Harold C. Sox

doi:10.1370/afm.1399

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Commentary on Hoffman et al.
H. Ballentine Carter

Published on: 28 November 2012
Commentary on 'Reconciling Primary Care and Specialist Perspectives on Prostate Cancer Screening'
Ian M. Thompson, Jr

Published on: 21 November 2012
Authors' Response
Richard M. Hoffman

Published on: 19 November 2012
Practice guidelines produced by subspecialists must meet higher standards
Kenneth W. Lin

Published on: 15 November 2012

Published on: (28 November 2012)
Page navigation anchor for Commentary on Hoffman et al.
Commentary on Hoffman et al.
H. Ballentine Carter, Director of Adult Urology
Other Contributors:
Dr. Hoffman and colleagues comment on the discrepancy between the perspectives of specialists and primary care physicians in the matter of guidelines for cancer screening. Their main argument appears to be that this discrepancy would be reduced if only specialty organizations followed appropriate standards for developing guidelines. To illustrate this point they use the example of prostate cancer screening and guidelines...
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Dr. Hoffman and colleagues comment on the discrepancy between the perspectives of specialists and primary care physicians in the matter of guidelines for cancer screening. Their main argument appears to be that this discrepancy would be reduced if only specialty organizations followed appropriate standards for developing guidelines. To illustrate this point they use the example of prostate cancer screening and guidelines issued by two organizations namely, the American Urology Association (AUA) and the National Comprehensive Cancer network (NCCN), and argue that the fact that the recommendations by these panels to consider screening men beginning at age 40 rather than age 50 is not evidence-based. More generally, they recommend against proposing screening strategies without any direct evidence of benefit.
As members of both panels and as prostate cancer researchers concerned that screening policies be based on reliable evidence as much as possible, we welcome the opportunity to discuss the issue of specialist versus generalist perspectives in policy development. We have witnessed the difference between a specialty group (e.g. the AUA) that views prostate cancer as "the threat" and a panel (e.g. US Preventive Services Task Force - USPSTF) that sees prostate cancer as one of "many threats" to overall health. While the evidence that guideline panels evaluate may be the same, the weighting of the evidence and the panel's perspective can be very different leading to differing interpretations of evidence and policy implications. Therefore, it is unclear to us whether the difference between the guidelines issued by specialty versus non-specialty panels is a function of the guideline development process or, ultimately, a consequence of the composition of the panels and the perspectives of their members.
The NCCN prostate early detection panel includes experts in medical oncology, radiotherapy/radiation oncology, urology, internal medicine, pathology, epidemiology and biostatistics as well as patient advocates. The process is more informal than the process outlined in Table 1 of Hoffman et al and is designed to produce guidelines that combine direct and indirect evidence with clinical experience. Recommendations are graded based on strength of evidence and the level of consensus among guideline panel members. For example, the recommendation to offer a PSA test beginning at age 40 years to average risk men who are well informed was updated in 2012 by the NCCN ( http://www.nccn.org/professionals/physician_gls/f_guidelines.asp), and was categorized as level 2A. This level of recommendation corresponds to a lower level of evidence but a uniform consensus that the guideline is appropriate. This consensus was based on the evidence that prostate cancer is a disease with a prolonged natural history, for which it is well known that younger men with more than a 10-15 year life expectancy are more likely to benefit from diagnosis and treatment. We acknowledge that the process could almost certainly be strengthened by the principles outlined by Hoffman and colleagues but whether and by how much this would change the resulting guideline is unclear.
Regarding Hoffman and colleagues' comments about the AUA we note that, to be fair, the AUA has never produced a Guideline on prostate cancer detection, but rather a Best Practice Statement issued in 2009 on PSA (reference 4 in current paper). This Best Practice Statement included not only the use of PSA for diagnosis, but also the use of PSA for staging and follow-up of patients. A Best Practice Statement is by definition "evidence based guidance which reflects the principles of the urology profession", in which "panel members contribute knowledge and experience to conclusions", using a process that involves "a consensus based on a literature review." The Best Practice Statement is different from a Guideline that involves the principles outlined in Table 1 of the current paper.
The AUA is currently in the process of developing a guideline for prostate cancer early detection that follows all of the standards as outlined by the Institute of Medicine and emphasized by the authors of the current paper. The panel is multidisciplinary in scope, and the guideline will be reviewed by a wide spectrum of stakeholders. However, based on our experience, and for reasons outlined above, it is unclear that this process will lead to the same guideline as issued by the USPTF. In particular, the main direct evidence available regarding screening benefit is subject to differing interpretations; the USPSTF has interpreted the results from screening trials as evidence that screening provides little or no benefit while others view the results as more positive given the limitations of the trials. (1,2)
In conclusion, we believe that the differences between specialist guidelines panels are understandable and are at best only partially a function of the guideline development process. Moreover, even when guidelines panels concur, clinical use of the practice recommendations that follow is not guaranteed. For example, the perspective of the AUA is that the benefits of screening decline with age (reference 4 in current paper) and this is concordant with the 2008 recommendation of the USPSTF to discourage use of the PSA test among men over age 75 years. However, the rate of use of the PSA test for prostate cancer screening among the elderly is high. (3) This is more likely a result of patient expectations and time constraints on the part of the primary care physician (4), rather than any recommendation that elderly men should continue PSA based screening.
In the case of the ongoing AUA guideline development process, we hope to accomplish the goals that the authors of the current paper have outlined for guideline development, but recognize that the adoption into clinical practice may require a more sophisticated approach than simple publication, such as clinical decision support tools provided to clinicians at the point of care.
REFERENCES
1. Carlsson S, Vickers AJ, Roobol M, Eastham J, Scardino P, Lilja H, Hugosson J. Prostate cancer screening: facts, statistics, and interpretation in response to the US Preventive Services Task Force Review. J Clin Oncol 2012; 30:2581-4.
2. Etzioni RD. Review of evidence concerning PSA screening for prostate cancer has limitations as basis for policy development. Evid Based Med 2012 Jul 7 [Epub ahead of print].
3. Prasad SM, Drazer MW, Huo D, Hu JC, Eggener SE. 2008 US Preventive Services Task Force recommendations and prostate cancer screening rates. JAMA 2012; 307:1692-4.
4. Pollack CE, Platz EA, Bhavsar NA, Noronha G, Green GE, Chen S, Carter HB. Primary care providers' perspectives on discontinuing prostate cancer screening. Cancer 2012; 118:5518-24.
Competing interests: None declared
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Competing Interests: None declared.
Published on: (21 November 2012)
Page navigation anchor for Commentary on 'Reconciling Primary Care and Specialist Perspectives on Prostate Cancer Screening'
Commentary on 'Reconciling Primary Care and Specialist Perspectives on Prostate Cancer Screening'
Ian M. Thompson, Jr, Director
First, a disclaimer: while a member of the AUA and former Chair of the Prostate Cancer Treatment Guideline Panel, I was not on the Panel that developed the PSA Best Practices Statement.(1,2) Note: this was a Statement, not a formal Guideline. While the reader of the Statement will see the rigor of the literature review, it was not performed in the more formalized manner of an AUA Guideline. The NCCN methodology was sim...
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First, a disclaimer: while a member of the AUA and former Chair of the Prostate Cancer Treatment Guideline Panel, I was not on the Panel that developed the PSA Best Practices Statement.(1,2) Note: this was a Statement, not a formal Guideline. While the reader of the Statement will see the rigor of the literature review, it was not performed in the more formalized manner of an AUA Guideline. The NCCN methodology was similar. I was impressed in the Hoffman manuscript by the clear synthesis of the evidence and conclusions regarding PSA testing: there is likely a benefit in some men if all men with prostate cancer diagnosed by PSA testing are treated, the number needed to treat to prevent one death is high and there may be a net harm. Dropping PSA testing to age 40 may exacerbate this problem, especially if it is performed annually thereafter. We understand that (a) prostate cancer is uncommon in men 40-50, (b) when cancer is found in this age range, it is generally low-volume and low-grade (so- called indolent cancer and probably ought not be given the moniker 'cancer'), and (c) the unfortunate side effect of testing is that a range of circumstances often leads to biopsy. An example is the 45 year old man whose PSA at age 40 was 0.3 and at 45 triples to 0.9 ng/mL. If without other risk factors, his likelihood of high-grade disease on biopsy is less than 1%. (I've inflated his age to 55 to use the PCPT Risk Calculator; this overestimates his risk.[3]) Unfortunately, if a biopsy is performed at this age and if cancer is found, you usually detect a low-grade, probably-inconsequential cancer. He then faces either 30-40 years of active surveillance for his cancer (repeated biopsies every 1-2 years, frequent physician visits) or just 'getting it over with' and treating the tumor with surgery or radiation to avoid the burden of surveillance. Obtaining a PSA at age 40 is a well-intentioned option to 'catch' the small number of men who are most likely to develop an aggressive prostate cancer at a young age. It's probably not evidence-based but for the man with significant risk factors, could be reasonable. Certainly, annual PSA testing for 40-50 year olds is probably not warranted. I applaud the analysis by Hoffman; PSA testing has the opportunity to produce a net benefit but must be used and interpreted wisely.
References
1. Thompson I, Thrasher JB, Aus G, Burnett AL, Canby-Hagino ED, Cookson MS, D'Amicao AV, Dmochowski RR, Eton DT, Forman JD, Goldenberg SL, Hernandez J, Higano CS, Kraus SR, Moul JW, Tangen CM; AUA Prostate Cancer Clinical Guideline Update Panel. Guideline for the management of clinically localized prostate cancer; 2007 update. J Urol 2007;177:2105- 31.
2. Greene KL, Albertsen PC, Babaian RJ, Carter HB, Gann PH, Han M, Kuban DA, Sartor AO, Stanford JL, Zietman A, Carroll P. Prostate specific antigen best practice statement: 2009 update. J Urol 2009;182:2232-41.
3. Thompson IM, Ankerst DP, Chi C, Goodman PJ, Tangen CM, Lucia MS, Feng Z, Parnes HL, Coltman CA Jr. Assessing prostate cancer risk: results from the Prostate Cancer Prevention Trial. J Natl Cancer Inst 2006;98:529-34.
Competing interests: None declared
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Competing Interests: None declared.
Published on: (19 November 2012)
Page navigation anchor for Authors' Response
Authors' Response
Richard M. Hoffman, Physician
We appreciate Dr. Lin's insightful comments. Not only has the AUA criticized the USPSTF for not including a urologist on the guideline panel, but they have strongly endorsed House of Representatives bill 5998 (http://www.govtrack.us/congress/bills/112/hr5998/text), the USPSTF Transparency and Accountability Act of 2012. This bill would require changing the composition of the guideline panel to include not only special...
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We appreciate Dr. Lin's insightful comments. Not only has the AUA criticized the USPSTF for not including a urologist on the guideline panel, but they have strongly endorsed House of Representatives bill 5998 (http://www.govtrack.us/congress/bills/112/hr5998/text), the USPSTF Transparency and Accountability Act of 2012. This bill would require changing the composition of the guideline panel to include not only specialists, but also relevant stakeholders from the medical products manufacturing community. Furthermore, the bill requires that "interested parties" be able to request the Task Force to review...previous recommendations or guidelines. While some experts in evidence-based medicine have quibbled with specific Task Force recommendations, there are no concerns about the rigor of the systematic reviews or the objectivity of the recommendations. This bill, which fortunately is very unlikely to pass, would substantially undermine the credibility of the Task Force.
Competing interests: None declared
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Competing Interests: None declared.
Published on: (15 November 2012)
Page navigation anchor for Practice guidelines produced by subspecialists must meet higher standards
Practice guidelines produced by subspecialists must meet higher standards
Kenneth W. Lin, Director, Primary Care Health Policy Fellowship
This excellent commentary by Dr. Hoffman and colleagues rightly points out that practice guidelines produced without the involvement of generalists are less likely to be trustworthy or based on high-quality evidence. Since the release of the USPSTF's recommendation against PSA- based prostate cancer screening earlier this year, the American Urological Association has loudly criticized the USPSTF for not including a urologi...
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This excellent commentary by Dr. Hoffman and colleagues rightly points out that practice guidelines produced without the involvement of generalists are less likely to be trustworthy or based on high-quality evidence. Since the release of the USPSTF's recommendation against PSA- based prostate cancer screening earlier this year, the American Urological Association has loudly criticized the USPSTF for not including a urologist on its guideline panel. I look forward to the day that the AUA routinely invites family physicians to sit on its guideline panels!
How can clinicians be sure that a practice guideline is any good? A few years ago, David Slawson and I proposed several attributes that health professionals should use to identify good clinical practice guidelines:
1. Comprehensive, systematic evidence search with end date noted 2. Evidence linked directly to recommendations via strength of recommendation grading system 3. Recommendations based on patient-oriented rather than disease-oriented outcomes 4. Transparent guideline development process 5. Potential conflicts of interest identified and addressed 6. Prospectively validated (i.e., guideline use has been shown to improve patient-oriented outcomes) 7. Recommendations offer flexibility in various clinical situations
In 2011, an Institute of Medicine panel published an important report titled Clinical Practice Guidelines We Can Trust, which included many of the same criteria. Later that year, the American Cancer Society announced that it would revise its methods for creating cancer screening guidelines to be consistent with the IOM's standards.
That's a positive step, especially for a group that has produced some poor-quality guidelines in the past, but are others doing the same? Unfortunately, no. A recent study in the Archives of Internal Medicine surveyed a random sample of 130 guidelines in AHRQ's National Guideline Clearinghouse for adherence to the IOM's standards. The findings were disappointing, to say the least: "Fewer than half of the guidelines surveyed met more than 50% of the IOM standards. Barely a third of the guidelines produced by subspecialty societies satisfied more than 50% of the IOM standards surveyed" (1).
In a fee-for-service payment system, doctors already have few incentives to follow practice guidelines, resulting in abuses of patients such as excessive rates of screening colonoscopy (2). And as the Archives study showed, even conscientious physicians who provide guideline- concordant care may in fact be relying on documents that are worth little more than the paper they are printed on, especially if they were written by specialists whose incomes depend on doing more consultations and procedures.
The bottom line is that to protect our patients, primary care physicians must demand that subspecialist guideline-producing organizations meet higher standards. Groups that continue to convene guideline panels with financial and other conflicts of interest; continue to value the opinions of specialists more than those of generalists; and continue to make strong recommendations based on disease-oriented evidence or, worse yet, no evidence at all; should be called out for what they are: a clear and present danger to the health and well-being of every person who seeks health care.
1. Kung J et al. Failure of practice guidelines to meet Institute of Medicine standards. Arch Intern Med 2012 pub online before print doi:10.1001/2013.jamainternmed.56.
2. Goodwin JS et al. Overuse of screening colonoscopy in the Medicare population. Arch Intern Med 2011;171:1335-1343.
Competing interests: None declared
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Competing Interests: None declared.