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The article discusses the importance of valid quality of life (QOL) questionnaires in treating patients with ocular allergy and how this condition impacts the patient's everyday life. Topics include the guidance from the U.S. Food and Drug Administration on the development and implementation of patient reported outcomes (PROs) in clinical trials, the development of QoL questionnaires through strict statistical analysis of validity, and telephone and online surveys.

AIMS: The primary aim of this study was to investigate whether a questionnaire developed for patients with rheumatoid arthritis (RA) could also be used with patients who have fibromyalgia. A secondary aim was to assess the impact of fibromyalgia on sexuality. METHOD: In the first of two phases the face and content validity of a sexuality questionnaire already being used in patients with RA were assessed in a qualitative, audio-taped, interview study of five patients with fibromyalgia. The second phase consisted of a self-report questionnaire distributed to 60 patients with fibromyalgia. FINDINGS: The interview data confirmed that the content of the RA sexuality questionnaire was relevant to patients with fibromyalgia. A total of 43 (72%) questionnaires were returned and, of these, 41 (95%) were usable. Patients reported that fibromyalgia had altered their sexual relationship. They cited pain, stiffness, fatigue, reduced sexual drive and the impact of drug therapy as the main reasons. CONCLUSION: The symptoms associated with fibromyalgia had a negative effect on sexual enjoyment. The questionnaire appears to be useful in addressing sexuality in patients with fibromyalgia. [ABSTRACT FROM AUTHOR]