The impact of informed consent on patient interest in prostate-specific antigen screening

Arch Intern Med. 1996 Jun 24;156(12):1333-6.


Background: Because of the many uncertainties surrounding screening for prostate cancer, authorities recommend that patients be involved in the screening decision.

Objective: To determine the impact of informed consent on patient interest in undergoing prostate-specific antigen (PSA) screening.

Methods: Men 50 years or older with no prior PSA testing and no history of prostate cancer presenting to 1 of 4 university-affiliated primary care practices were eligible for enrollment. Patients were randomized to receive either a scripted informational intervention simulating an informed consent presentation (intervention group, n = 103) or a single sentence about the PSA (control group, n = 102). The main outcome measure was patient interest in undergoing PSA screening measured on a 5-point Likert scale.

Results: Patients who received the informational intervention were significantly less interested in undergoing PSA screening than controls (mean difference in interest, 0.8 on 5-point scale, P < .001). Informed patients were much less likely to indicate high interest in screening (odds ratio, 0.34; 95% confidence interval, 0.19-0.60; P < .001). In a multivariate model, family history of prostate cancer was associated with increased interest and advancing age with decreased interest in PSA screening, but the informational intervention remained the strongest predictor of interest.

Conclusions: Among primary care patients of predominantly lower socioeconomic status, those who received informed consent were significantly less interested in PSA screening than those who did not. For physicians who offer the PSA as a screening test, this finding highlights the importance of apprising patients of the associated benefits, burdens, and uncertainties and allowing them to participate in the screening decision.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Control Groups
  • Decision Making
  • Disclosure*
  • Humans
  • Information Dissemination*
  • Informed Consent*
  • Male
  • Mass Screening* / methods
  • Middle Aged
  • Patient Education as Topic*
  • Patient Participation*
  • Prostate-Specific Antigen / blood*
  • Prostatic Neoplasms / diagnosis*
  • Prostatic Neoplasms / immunology
  • Prostatic Neoplasms / prevention & control
  • Risk Assessment
  • Uncertainty
  • Vulnerable Populations


  • Prostate-Specific Antigen