Development and initial validation of a new preference-based disease-specific health-related quality of life instrument for erectile function

Qual Life Res. 2004 Mar;13(2):349-59. doi: 10.1023/B:QURE.0000018482.71580.f2.


Health-related quality of life instruments may be generic or specific. In general, only generic instruments use preference-based scoring. We report on a novel approach to combine in one instrument the strengths of the specific approach, greater disease relevance and responsiveness, with those of preference-based scoring, generalizability through utilities.

Objectives: The primary objective was to develop a self-administered, preference-based instrument capable of measuring utilities in the disease-specific context of erectile dysfunction (ED).

Methods: Content derivation/validation began with a literature review. Eight attributes (domains) were selected to provide clinical experts structure for focus group discussion. Four levels describing a continuum of dysfunction-function were defined for each domain. Each domain, including functional levels, was reviewed and modified until consensus was achieved regarding content. This content was then integrated into a preference based scoring instrument using two visual analogue scales (VAS) with which patients rated three 'marker' health states (representing mild, moderate and severe ED), their self-state and a previously validated external marker state. The instrument was pilot tested, and implemented in a clinical trial. Initial validation analyses have been performed.

Results: A self-administered, preference-based, VAS instrument was developed for use in the ED population, and the instrument was feasible to complete, was reliable beyond the threshold of acceptability established a priori and demonstrated good validity. Evidence of these properties accumulates over time and this study begins that process with this instrument. Responsiveness is being assessed in the context of a clinical trial.

Publication types

  • Comparative Study
  • Research Support, Non-U.S. Gov't
  • Validation Study

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Canada
  • Clinical Trials as Topic
  • Erectile Dysfunction / drug therapy
  • Erectile Dysfunction / psychology*
  • Humans
  • Male
  • Middle Aged
  • Pain Measurement / instrumentation*
  • Pain Measurement / methods
  • Patient Satisfaction / statistics & numerical data*
  • Piperazines / therapeutic use
  • Psychometrics / instrumentation*
  • Purines
  • Quality of Life*
  • Sickness Impact Profile*
  • Sildenafil Citrate
  • Sulfones
  • Surveys and Questionnaires
  • Vasodilator Agents / therapeutic use


  • Piperazines
  • Purines
  • Sulfones
  • Vasodilator Agents
  • Sildenafil Citrate