Patient Reported Outcomes (PRO) in Acromegaly
Research type
Research Study
Full title
A STUDY TO DEVELOP AND EVALUATE A NEW PATIENT REPORTED OUTCOME (PRO) QUESTIONNAIRE ASSESSING TREATMENT SATISFACTION IN ADULT PATIENTS WITH ACROMEGALY
IRAS ID
180105
Contact name
Peter J. Trainer
Contact email
Duration of Study in the UK
0 years, 6 months, 4 days
Research summary
This is a non-interventional Patient Reported Outcomes (PRO) Study of adult (18 to 75 years) patients with acromegaly. The study will consist of two distinct phases; each will enroll different subjects:
Qualitative Research Phase: Once a patient has provided informed consent to participate, a telephone interview will be scheduled by the Investigational site personnel between the patient and Health Outcomes Solutions (HOS). The patients’ personal identifying data will only be known to the direct care team at the site; therefore patient contact information will not be known by HOS. Eight to 10 telephone interviews, each lasting no more than 60 minutes, consisting of open-ended concept elicitation-type questions to better understand concepts specific to treatment satisfaction among individuals with acromegaly, will be conducted. Following completion of these initial telephone interviews, the first draft PRO questionnaire, will be developed. Ten to 15 in-person interviews will then be conducted in-person at the Investigational site by an experienced HOS researcher. These subjects will be asked an abbreviated set of the concept elicitation questions from the initial interviews, as well as debriefing questions on the draft PRO. Each interview will last no more than 60 minutes. The draft questionnaire will be revised as necessary, prior to being implemented in the validation study.
Validation Phase: Subjects will self-administer the new PRO questionnaire and collateral PRO measures [including the AcroQol, Treatment Satisfaction for Medication Questionnaire (TSQM), and Patient Global Assessment (PGA)] up to three times over a three-month time period.
Patients will be compensated for their participation in the study (details see A46).
REC name
South East Scotland REC 02
REC reference
15/SS/0132
Date of REC Opinion
6 Aug 2015
REC opinion
Further Information Favourable Opinion