Patient Reported Outcome Measures

Patient Reported Outcome Measures

1. Use Recommend in clinical trials
2. Patient needs a quiet area conducive for form completion
3. Do not rephrase or reinterpret any instruction (may change the measure and introduce clinical bias)

An investigator may not assist a subject in answering or interpreting any of the items.

Review after completion before allowing the subject to leave:

1. Inspect the forms to ensure completeness, 
2. Inspect the forms for clinically significant responses (Dr I am going to kill myself) - before allowing the patient to leave the site.

CSFQ - Changes in Sexual Functioning Questionnaire

1. Male and Female versions: Ensure that the right version is given to the male and or female subject.
2. Object: measures medication-related effects on sexual functioning
1. It appears that sexual dysfunction is underreported
2. Patients are reluctant to volunteer information
3. Site staff must allow privacy for completion and review of the form
4.  Always be non-judgmental and matter of fact - to help evaluate the medication under study.
3. Allow 5 minutes (average for) for completion of 14 questions, on a scale 1 to 5
4. Inspect the forms to ensure completeness - all questions have been answered 
5. Inspect the forms for clinically significant responses