Development of a questionnaire for use in clinical trials

When Procter and Gamble Pharmaceuticals needed to develop a questionnaire for use in the clinical trial of a new product prior to submission to the US Federal Drugs Administration (FDA) they approached us to join a team of international experts in the field.

We worked with Len Derogatis of the University of Maryland and Caran McHorney from Indiana University to develop the Profile of Female Sexual Functioning (PFSF), a diagnostic instrument for the DSM-IV(R) diagnostic category of Female Hypoactive Sexual Desire Disorder (HSDD). HSDD, a combination of low sexual desire and associated distress, is often a side-effect of ovariectomy or hysterectomy.

The development of the PFSF went through several stages including:

  • focus groups of patients to generate appropriate laymans' terminology for the condition
  • item writing based on the interviews and feedback from physicians, counselors and other professionals
  • pilot studies of a longer form of the questionnaire
  • item analysis of the results
  • administration to appropriate patient and non-patient groups
  • translation, back translation and cognitive interviews in the various languages of the project (French, English, Italian and Dutch)

The final form of the instrument involved 37 items, grouped in seven domains: sexual desire, arousal, orgasm, sexual pleasure, sexual concerns, sexual responsiveness and sexual self-image. A trial of the PFSF in eight countries (France, Germany, Holland, Italy, the UK, Canada, the USA and Australia) showed increased satisfying sexual activity and desire in patients with HSDD.

Subsequent double-blind clinical trials of a testosterone patch in comparison with a placebo showed that the use of the patch led to a significant improvement in sexual desire in 

  • Naturally menopausal women with low libido
  • Surgically menopausal women with low libido

The product has now been marketed throughout Europe asIntrinsa™, a female testosterone patch.

Contact usfor more information about our work in developing instruments for use in clinical trials.