March 01, 2015 Dispute Resolution

Patient Voices in Clinical Practice Guidelines

Integrating the perspectives and experiences of patients into the delivery of America’s health care is a key initiative of the Patient Protection and Affordable Care Act. This article describes the authors’ experiences facilitating the development of clinical practice guidelines in a multi-stakeholder panel including patient representatives and experts.

Background. The PSA test, which measures the amount of prostate-specific antigen in a man’s blood, is used to identify men who might have prostate cancer. Until recently, doctors routinely recommended the test to their patients 50 years of age and older. But in 2012 the U.S. Preventive Services Task Force published a report recommending that the PSA test not be routinely used, concluding that the number of lives saved by PSA screening is small because most men with prostate cancer will not die from it and that the harms stemming from unnecessary treatment outweigh the benefits. Not everyone agrees, however, and many argue that the task force guidelines go too far, that the benefits of PSA screening should not be lost, and that advances in diagnosis and treatment of prostate cancer make many of the harms avoidable.

Concerned by this uncertainty, Dr. Roger Luckmann, a clinician and associate professor of medicine at the University of Massachusetts Medical Center, initiated a project to involve patient representatives in the development of guidelines for the PSA test and engage professional facilitators to assist them. The hope was that clearly reasoned guidelines created by such a broad-based group would be convincing to both doctors and patients.

The process. Luckmann organized a management team composed of four groups: an evidence group that summarized research articles and responded to panelists’ questions; a logistics group that recruited panelists, scheduled meetings, and made all meeting arrangements; a facilitation group that designed the process and facilitated the meetings; and a research group. The panel had six primary care physicians, six patient representatives, two health systems representatives, two health insurers, two public health representatives, and three urologists.

Recruiting panelists. The facilitation team recommended to the management team that patient representatives and primary care physicians have the largest representation on the panel so that the target audience would have the loudest voice in the process. Concern about vested interests also led the facilitators to recommend that “consensus” be defined as a consensus among the constituent panelist groups so that no individual urologist or payer, for example, could block the outcome, with the proviso that any individual who disagreed with his or her group could write a dissenting opinion that would be published as part of the clinical practice guidelines.

The recruitment of African American patient representatives was also a concern. Among black men, prostate cancer occurs more frequently, tends to manifest earlier in their lives, may be more aggressive, and more often causes death than among white, Asian, or Hispanic men. The logistics team was able to find only two African American patient representatives willing to participate, including, as it turned out, a panel member who dropped out because of scheduling. The facilitators were concerned about how the African American man would feel about being responsible for representing all black men and also how being the only black man on the panel would influence his participation. But the most important implication of this—discussed below—was a complete surprise.

Values and science. Weighing benefits against risks is always problematic: How does one compare the worth of a life saved with the value of avoiding the various harms? When, as in this case, the potential harms are substantial but overwhelmingly nonfatal, while the benefit of lives saved is a relatively small number, the value conflict is more difficult.

Initially, a working group was not able to come to a conclusion and left the question open for the next panel session. The facilitators thus faced the question of whether to let the panelists debate it until they came to a consensus or to suggest leaving the issue unresolved. And then, in a lucky break, a research team previously unknown to the group, working on the same problem and using mathematical modeling in addition to the existing research, was able to produce a set of harms-to-benefits ratios that converted the language of value tension into the language of quantitative choice. With this tool, the panelists were able to decide on what became the crucial point: Should screening start at 45, 50, or 55? Going into the final panel, there was general agreement that screening for average-risk men should begin at 50 and for high-risk men at 45, the conventional ages at which to begin screening.

Moving playing field. At the fourth panel meeting, two matters caught the facilitators off guard and nearly derailed the process. The first surprise came at the beginning of the meeting when most of the panel members, including the facilitators, learned that the American Urological Association (AUA) had recently released a revised guideline. There was general agreement that both the panel’s guidelines and the AUA’s would likely be more persuasive if they were consistent.

One element in the AUA guideline, though seemingly noncontroversial, proved very troublesome. The AUA had concluded that by raising the age at which screening should begin from 50 to 55, there would likely be a meaningful reduction in harms and a negligible reduction in lives saved. These relative values of harms and benefits fit those articulated by the panel, so there was no reason to anticipate any resistance to following the AUA. But raising the starting age from 50 to 55 implied that the beginning age for screening high-risk men should also be raised by five years, from age 45 to 50.

At this moment, the panel faced its second surprise. The sole black patient representative and the representative from the Massachusetts Department of Public Health shared with the group that for years a public health campaign had been in place in African American communities to promote the age of 45 as the starting point for screening African American males. The community groups the black patient representative spoke for didn’t want to lose ground on this campaign, and the black patient representative said that he had been encouraged by his community not to support any starting age over 45. But leaving the high-risk starting age at 45 while raising the normal starting age to 55 was problematic. No known scientific rationale or evidence would support a ten-year differential, so the evidence-based character of the panel’s guideline would be undermined.

This revelation posed a serious challenge to the panel. In the end, the final recommendation did not follow the AUA language, staying instead with a starting age of 50 and also adding a two-tier high-risk approach: 45 for African American and other high-risk men and 40 for those with two risk factors.

Conclusion. The process produced a consensus. The recommended clinical guidelines were submitted to an organization that specializes in seeking ways to implement clinical guidelines in Massachusetts that it has examined and approved, and it has now approved the recommended guidelines.

ABA Section of Dispute Resolution

This article is an abridged and edited version of one that originally appeared on page 28 of Dispute Resolution, Summer 2014 (20:4).

For more information or to obtain a copy of the periodical in which the full article appears, please call the ABA Service Center at 800/285-2221.

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