Decision aids and patient choice of therapy: a randomized, controlled, clinical trial


A new paper in BJU International reports data about the development of an appropriate decision aid and the results of a randomized, controlled, clinical trial designed to investigate the effects of use of that decision aid (as opposed to “usual care”) on patients’ selection of radiation therapy as opposed to radical prostatectomy for localized disease.

As almost all readers of this blog will be well aware, patients newly diagnosed with localized prostate cancer are potentially eligible for a whole variety of types of treatment, of which the three most commonly available are radical prostatectomy, external beam radiation therapy, and brachytherapy.

Between March 2008 and February 2011, van Tol-Geerdink et al. randomized a series of Dutch patients, diagnosed with localized disease at one of three institutions, to one or other of two basic processes to help them decide on the form of treatment that felt most appropriate:

  • Usual care — in which patients just discussed their options with the specialist who had diagnosed their condition
  • Presentation and use of a decision aid (with the assistance and support of a member of the research team) followed by discussion of their options with the specialist who had diagnosed their condition

For each man who was randomized to the usual care group, two men were randomized to the decision aid group.

Only men for whom immediate localized treatment was felt to be appropriate were eligible for enrollment into the trial, so this study did not include men for whom active surveillance was a recommended or an elected option (largely because the decision aid tool developed for this study had not been designed to address that option).

The study was designed to include men with clinical stage T1-T3aN0M0 disease, all of whom were potential candidates for either radical prostatectomy or external beam radiation therapy and some of who were eligible for brachytherapy as well. (To be eligible for brachytherapy, for example, the patient had to have a prostate volume between 20 and 50 ml, a PSA level of ≤ 15 ng/ml, and a Gleason score of ≤ 7.)

The full text of the paper (a copy of which was kindly provided by Dr. Tol-Geerdink) gives details about the development of and the information in the decision aid they used. The “New” Prostate Cancer InfoLink feels that the information on outcomes and side effects of therapy offered in this particular decision aid was certainly within the range of sound accuracy. However, people are always going to quibble about the accuracy of such information.

The authors collected a great deal of data on patient decisions in this study. We will confine ourselves here to focusing on the most important findings:

  • 307 men were invited to participate in the study.
    • 36 simply declined to participate.
    • 14 were excluded because they were found to have other significant health problems.
    • 17 were excluded because they elected to be monitored on active surveillance.
  • A total of 240 men were enrolled into the study.
    • 163/240 patients (67.9 percent) were randomized to the decision aid group.
    • 77/240 patients (32.1 percent) were randomized to the usual care group.
    • 134/240 patients (55.8 percent) were potentially eligible for all three forms of treatment.
    • 106/240 patients (44.2 percent) were not eligible for brachytherapy.
  • In the usual care group
    • 73 percent of men elected radical prostatectomy (and 78 percent were actually treated this way).
    • 8 percent of men elected brachytherapy (and 4 percent were actually treated that way).
    • 12 percent of men elected external beam radiation (and 18 percent were actually treated that way).
    • 8 percent remained undecided.
  • In the decision aid group
    • 65 percent of men elected radical prostatectomy (and 68 percent were actually treated this way).
    • 20 percent of men elected brachytherapy (and 15 percent were actually treated that way).
    • 13 percent of men elected external beam radiation (and 17 percent were actually treated that way).
    • 2 percent remained undecided.

The hospital at which the patients were diagnosed and treated also appeared to have some impact on treatment selection.

The fundamental findings of the study reported by the authors were that:

  • Treatment choice was significantly affected by use of a decision aid (as compared to usual care), with many more men electing brachytherapy if they were eligible for this type of treatment.
  • Treatment choice was also affected by the hospital of intake.
  • Baseline patient characteristics (age, demography, physical function, tumor characteristics) did not vary significantly between hospitals.

The authors acknowledge two primary limitations to their study data:

  • The relatively small number of patients enrolled.
  • The inability to include active surveillance as a management option for appropriate patients.

Having said that, the authors clearly recommend the expanded use of patient aids to assist newly diagnosed men in selecting appropriate forms of therapy. In particular, they emphasize that fewer men who were exposed to their decision aid were undecided about their options after exposure.

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