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Randomized Controlled Trial
. 2021 May 12;21(1):154.
doi: 10.1186/s12911-021-01505-x.

Head to head randomized trial of two decision aids for prostate cancer

Affiliations
Randomized Controlled Trial

Head to head randomized trial of two decision aids for prostate cancer

Angela Fagerlin et al. BMC Med Inform Decis Mak. .

Abstract

Background: While many studies have tested the impact of a decision aid (DA) compared to not receiving any DA, far fewer have tested how different types of DAs affect key outcomes such as treatment choice, patient-provider communication, or decision process/satisfaction. This study tested the impact of a complex medical oriented DA compared to a more simplistic decision aid designed to encourage shared decision making in men with clinically localized prostate cancer.

Methods: 1028 men at 4 VA hospitals were recruited after a scheduled prostate biopsy. Participants completed baseline measures and were randomized to receive either a simple or complex DA. Participants were men with clinically localized cancer (N = 285) by biopsy and who completed a baseline survey. Survey measures: baseline (biopsy); immediately prior to seeing the physician for biopsy results (pre- encounter); one week following the physician visit (post-encounter). Outcome measures included treatment preference and treatment received, knowledge, preference for shared decision making, decision making process, and patients' use and satisfaction with the DA.

Results: Participants who received the simple DA had greater interest in shared decision making after reading the DA (p = 0.03), found the DA more helpful (p's < 0.01) and were more likely to be considering watchful waiting (p = 0.03) compared to those receiving the complex DA at Time 2. While these differences were present before patients saw their urologists, there was no difference between groups in the treatment patients received.

Conclusions: The simple DA led to increased desire for shared decision making and for less aggressive treatment. However, these differences disappeared following the physician visit, which appeared to change patients' treatment preferences. Trial registration This trial was pre-registered prior to recruitment of participants.

Keywords: Decision aids; Literacy; Patient education; Plain language; Prostate cancer; Shared decision making.

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Conflict of interest statement

None of the authors report any conflicts of interest or competing interests.

Figures

Fig. 1
Fig. 1
Study design
Fig. 2
Fig. 2
Percent people endorsing considering a treatment

References

    1. Stacey D, Légaré F, Lewis K, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2017. - PMC - PubMed
    1. Onel E, Hamond C, Wasson JH, et al. Assessment of the feasibility and impact of shared decision making in prostate cancer. Urology. 1998;51(1):63–66. doi: 10.1016/S0090-4295(97)00494-9. - DOI - PubMed
    1. Bill-Axelson A, Holmberg L, Garmo H, et al. Radical prostatectomy or watchful waiting in early prostate cancer. N Engl J Med. 2014;370(10):932–942. doi: 10.1056/NEJMoa1311593. - DOI - PMC - PubMed
    1. Hamdy FC, Donovan JL, Lane JA, et al. 10-Year outcomes after monitoring, surgery, or radiotherapy for localized prostate cancer. N Engl J Med. 2016;375(15):1415–1424. doi: 10.1056/NEJMoa1606220. - DOI - PubMed
    1. Wilt TJ, Brawer MK, Jones KM, et al. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med. 2012;367(3):203–213. doi: 10.1056/NEJMoa1113162. - DOI - PMC - PubMed

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