Change Request Memo

Change Request for CDC Prostate Cancer Screening Decision Aid Randomized Controlled Trial

We are proposing a change that would allow the methods of the study to be more aligned with the clinical practice at the participating clinics. This change would raise the study exclusion to a PSA level equal to or greater than 4 ng/mL. Physicians at the participating clinics agree that patients with PSA scores equal to or greater than 4 ng/mL are clinically differently than those below 4 ng/mL; these two groups of patients would receive different treatments. The current study exclusion of a PSA level greater than 3 ng/mL, which was selected based on published guidelines and is different from how physicians at these clinics treat patients.

This change will not affect the currently approved burden estimate because the same number of respondents would complete the patient eligibility screener. 

Table A12A: Estimated Annualized Burden (Hours)

Type of Respondents	Form Name	No. of Respondents	No. of Responses per Respondent	Average Burden per Response (in hours)	Total Burden Hours
Primary care providers	Provider survey	40	1	10/60	7
Men ages 55-69	Patient eligibility screener	900	1	8/60	120
Men ages 55-69	Pre-exposure survey	900	1	20/60	300
Men ages 55-69	Post-exposure survey	900	1	20/60	300
Men ages 55-69	Usability survey	300	1	18/60	90
Men ages 55-69	User experience interview	30	1	20/60	10
Men ages 55-69	Post-clinic survey	900	1	20/60	300
Clinic coordinators	Clinic coordinator interview	4	1	30/60	2
				Total	1,129