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

Abstract

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.

Readability of medicinal package leaflets: a systematic review

“…From the twelve exploratory studies with patients (or potential patients) receiving medicines (group B), ten were conducted to evaluate participant comprehension (usability and/or legibility tests, 1 , 2 , 6 , 8 , 11 , 12 , 19 , 21 , 25 , 26 or studies to specifically evaluate participant comprehension of the manner in which ADR were presented. 18 , 17 …”

“…The main problems identified in these 10 studies were patient (or potential patient) comprehension issues as some topics were poorly understood; 2 , 11 , 19 , 25 , 26 too complex texts, indicating the necessity of optimizing and simplifying the package leaflets; 1 , 11 , 12 , 21 and package leaflets not properly adapted for the low-literate patients, indicating the need to use simpler language. 1 , 6 , 8 , 19…”

“…The majority of the reviewed readability studies used package leaflets of specific medicines, including sildenafil, clozapine, acetaminophen, and diclofenac. 1 , 6 , 19 , 26 It is likely that these package leaflets were selected for the following reasons: the straight therapeutic indices of some medicines such as clozapine, 1 over-the-counter medicines (no prescription necessary), such as diclofenac and acetaminophen, and highly utilized medicines such as acetaminophen. 6 , 19 The package leaflets of these medicines are more likely to be consulted.…”

“…Diverse limitations were identified in these studies 1 , 2 , 6 , 8 , 1 1 , 12 , 19 , 21 , 25 , 2 6 and were categorized as follows: high diversity of methods, limited number of participants, lack of certain assessments (such as the evaluation of participant literacy, humor, cognitive state, and satisfaction), lack of multicenter or longitudinal studies, lack of studies on specific topics such as contra-indications and precautions, study of the package leaflets from a limited number of medicines and active ingredients, 1 , 6 , 19 , 26 and lack of pictograms (useful for low-literate patients) or other illustrations. 8 , 24 A few authors reported that the study limitations were contrary to good clinical practices, increasing the difficulty of precisely analyzing the results.…”

“…The inclusion of a limited number of patients or health professional in the readability and/or usability studies, particularly in the non-confirmatory studies; 1 , 5 , 6 , 8 , 11 , 19 , 21 , 22 , 25 , 26 …”