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The Ability of Men to Assess their Suitability to Take a Phosphodiesterase Type 5 Inhibitor: An Assessment of the Comprehension of Patient Information Materials


Karin Coyne, PhD, MPH, Center for Health Outcomes Research, United BioSource Corporation, 7101 Wisconsin Avenue, Suite 600, Bethesda, MD, 20814 USA. Tel: 513-943-7604; Fax: 513-943-4218; E-mail:


Introduction.  Erectile dysfunction is a treatable condition that affects a large proportion of men. Most men do not seek medical help for their ED because of embarrassment or social stigma that may lead some men to self-treat.

Aim.  To evaluate men's ability to self-assess their suitability for 50 mg sildenafil use after reviewing patient information materials.

Main Outcome Measures.  Patient rating of patient information materials, self-assessment of suitability for sildenafil use, and clinician assessment of sildenafil suitability.

Methods.  Men in the UK were recruited through newspaper, radio, and internet advertisements. Eligible men reviewed the 50 mg sildenafil patient information materials (packaging materials and patient information leaflet) at the in-person visit and then completed a survey to rate the materials and self-assess their suitability for sildenafil use. A clinician, blinded to the participant's ED status and self-assessed sildenafil suitability, then conducted a one-on-one interview to assess the participant's ED status and suitability for sildenafil treatment. The primary analysis was the concordance of self-assessed suitability versus clinician-assessed suitability.

Results.  The initial study phase included 113 generally healthy men, mean age 40.2 ± 13.1 years. The second phase included 70 men with comorbid prostate or cardiac conditions, mean age 60.7 ± 7.8 years. The 183 men rated the patient information materials as easy to understand; few participants reported problems understanding the materials, and many participants learned new information. The concordance rate between clinician-assessed suitability and self-assessed suitability was 73.9% (95% confidence interval [CI] = 66.7–81.2%). When accounting for men who would not take sildenafil even though they were suitable or would seek additional information from a healthcare professional prior to using sildenafil, the concordance rate was 90.1% (95% CI = 85.8–94.4%).

Conclusion.  The results of this UK study suggest that men are capable of using written sildenafil patient education materials to accurately assess their suitability for treatment with 50 mg sildenafil. Symonds T, Dean J, Coyne KS, Margolis MK, Hackett G, Edwards D, Marfatia A, and Schnetzler G. The ability of men to assess their suitability to take a PDE5 inhibitor: An assessment of the comprehension of patient information materials. J Sex Med 2010;7:2217–2225.