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Legal Implications of Prostate Cancer Screening
Introduction
The legal implications of prostate cancer screening flow from the formalization of expert opinion and scientific data into clinical practice guidelines (CPGs). These guidelines are a nexus between the daily clinical practice of prostate cancer care and the broader legal framework that permeates all medical practice. As public statements of appropriate care, they provide the lens through which clinical decisions between patients and their physicians can be judged, rightly and wrongly, by nonclinicians.
This chapter will explore how clinical decisions regarding prostate cancer screening are being scrutinized vis-a-vis CPGs, and highlight how these clinically oriented documents implicate myriad legal issues related to medical malpractice law. The content of the various prostate cancer screening CPGs are discussed elsewhere and will only be touched on briefly here.
Prostate cancer screening recommendations: a brief review
There are currently four prostate cancer screening guidelines listed by the Agency for Healthcare Research and Quality’s National Guideline Clearinghouse. Additionally, the National Comprehensive Cancer Network (NCCN) published a CPG for prostate cancer early detection. These guidelines all attempt to answer the same basic question: what group of asymptomatic men should be screened for prostate cancer? The answer to this question varies and has evolved over time.
The American Cancer Society (ACS) published an updated CPG on prostate cancer screening in 2010. The guideline recommended that men with at least a 10-year life expectancy have an opportunity to make an informed decision about whether to be screened for prostate cancer. Specifically, the ACS recommended that a discussion regarding the risks and benefits of screening should occur based on a patient’s risk of prostate cancer. Patients with the highest risk of prostate cancer should have this discussion at the age of 40 years, the next strata at 45 years, and average risk men at 50 years.
In contradistinction to the ACS CPG, the United States Preventive Services Task Force (USPSTF) recommended in 2012 that no men be screened for prostate cancer, regardless of prostate cancer risk, arguing that the risks of treatment outweighed the mortality benefit from screening. Less than one year later, however, the American Urological Association (AUA) and the American College of Physicians (ACP) issued more nuanced recommendations contradicting the USPSTF CPG. Similar to the ACS, the AUA and ACP stratified their recommendations by prostate cancer risk. The AUA recommended no screening in men <40 years, average risk men aged 40–54 years, men ≥70 years, or men with a life-expectancy <10–15 years; however, individualized decisions and shared decision-making were recommended for higher risk patients <55 years and men 55–69 years, respectively. The ACP supported the 2010 ACS recommendations stratifying shared decision-making based on prostate cancer risk, but unlike the ACS the ACP did not endorse providers making decisions on behalf of men who are unable to decide whether to screen for prostate cancer.
Finally, in September 2014 the NCCN published a comprehensive CPG covering many facets of prostate cancer care, including when to initiate and stop screening. There was uniform consensus among the panel members that baseline PSA testing be offered to healthy, well-informed patients aged 50–70 years, but nonuniform consensus regarding men outside of that age distribution.
As evidenced by the various CPG findings just outlined, the question of which men should be screened for prostate cancer remains controversial. Of course there is no novelty in the current debate over prostate cancer screening. Instead, what is new is the formalization of competing approaches to prostate cancer screening into contradictory CPGs. As will be discussed shortly, the implications of this formalization extend beyond the clinical exchange between patients and physicians.
Clinical practice guidelines: an introduction
Before addressing the legal implications of CPGs for prostate cancer screening, we will first explore the features of CPGs, how a CPG is developed, and the common criticisms leveled at these efforts to minimize practice variation while maximizing clinical value. The definition of CPGs varies across the medical literature, although there are several common features.
Features
CPGs are expert-driven, evidence-based statements defining appropriate diagnosis and treatment algorithms for particular clinical problems. Additionally, CPGs evolve over time in response to advancements in medical science and changes in professional and societal norms.
Whether disseminated by individual medical societies, physician consortiums, or networks of academic medical centers, the individuals charged with defining best or sound practices should have expertise relevant to the clinical question that the CPG is answering. For example, authorship of the NCCN, AUA, ACS, and ACP CPGs for prostate cancer screening included urologic surgeons, medical oncologists, and radiation oncologists with expertise in prostate cancer management. A notable exception to this rule is the USPSTF CPG, authored by experts in primary care, public health, and epidemiology.
The level of evidence available to support CPGs is variable and the strength of CPG recommendations should correspond to the strength of the evidence. Randomized, controlled trials (RCTs) are considered the highest level of evidence. However, discrepancies between RCT patient populations and patient populations treated in the non-RCT setting make it difficult to project RCT evidence onto the general population. In these instances there is increased reliance on observational studies and simulation models.
Finally, CPGs must be evolving. The contours of CPG recommendations must shift in response to advancements in medical science and changes in professional and societal norms regarding diagnostic and treatment options. This dynamic process may in fact be the greatest challenge in CPG science given the significant costs associated with CPG development.
Process
The process for developing CPGs was largely decentralized and without standardization until an Institute of Medicine (IOM) study published in 2011. The report, entitled “Clinical Practice Guidelines We Can Trust,” established eight principles for CPG development. These principles set out national standards for establishing transparency, managing conflict of interest (COI), guideline development group composition, systematic evidence reviews, defining the strength of evidence for all recommendations, articulation of recommendations, external review, and CPG updates. A detailed discussion of each standard is beyond the scope of this chapter; however, it is worth taking a closer look at the standards described for COI and guideline development group composition as these are often targeted by CPG critics.
COI is a challenging issue to address in the CPG process, and it encompasses the individuals involved in the CPG process and those entities responsible for funding the effort. Regarding individual COI, it can be difficult to acquire the necessary expertise for CPGs with a zero tolerance COI policy. To address this issue the IOM has called for a series of limits on COI, including divestment by CPG authors from financial interests related to the CPG topic, limits on the percentage of CPG authors with COI, and prohibitions against chairs or cochairs of CPG development groups from having any COI. Less concrete COI standards are prescribed by the IOM for organizations that fund CPGs, stating simply that such entities should have no role in CPG development.
The IOM makes particular recommendations regarding the composition of groups responsible for CPG development. In addition to a range of clinical experts, the report underscores the importance of diverse, multidisciplinary methodological expertise and patient participation. Specifically, individual patients and patient advocate organizations are identified as critical means for ensuring public involvement and support.
Criticism
Despite the advancements and standardization in CPG science described earlier, there are many notable criticisms of CPGs aimed at the failure of CPGs to clarify best practices or standards. These criticisms can be broadly categorized into critiques of CPG content, evidence, and process.
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