Validation of a Quality of Life Metric "Prolac-10"

This is a single-site validation study of a novel quality of life study for patients undergoing medical therapy for prolactinoma. Patients will be consented before starting their medical regimen and complete the "Prolac-10" questionnaire for baseline and will continued to be followed for 13-weeks into their medical care. The primary goal of this study is to validate the novel quality of life questionnaire in terms of sensitivity, repeatability, and consistency. Secondarily, we aim to validate the test-retest characteristics to further validate sensitivity, repeatability, and consistency.

The Prolac-10 metric is Copyright © 2019. The Ohio State University. Modification/derivative rights reserved, all other rights available.

Primary outcomes

• Validate the "Prolac-10" quality of life metric [13-weeks post medical therapy start date]: In patients diagnosed with a Prolactinoma, validate the novel quality of life questionnaire, Prolac-10 by testing its sensitivity and internal consistency.

Secondary outcomes

• Validate the test-retest characteristics of the Prolac-10 [13-weeks post medical therapy start date]: Validate the test-retest characteristics of the Prolac-10 to further validate sensitivity, repeatability, and consistency.

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patient has been diagnosed with prolactinoma by use of appropriate blood tests and brain imaging.
* 18 years of age or older
* The subject must in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent

Exclusion Criteria:

* Patient is a prisoner
* Patient is not English speaking
* Patient has been previously treated for prolactinoma
* Patient is pregnant at time of diagnosis and treatment

• Douglas Hardesty, MD, Principal investigator, Ohio State University