Screening for Ovarian Cancer: Psychobehavioral Outcomes

The prior reviews noted many strengths of the initial application, including the experience of the investigative team, the unique clinical research resource furnished by the University of Kentucky Ovarian Cancer (OC) screening program, and the productivity of the investigative team during the 4 year project period to date. Reviewers also noted significant strengths in the research design and procedures, the data and power analysis plans, the variables and measures chosen for study, and the conceptual framework that guided selection of study variables. The significance of the topic of study - response to abnormal, yet ultimately benign, abnormal test results during cancer screening - was also noted. We are grateful for these positive comments and are confident this revised application retains all strengths noted in the initial reviews. Two fundamental concerns were paramount in determining the initial evaluation of this continuation application. In a nutshell, reviewers were concerned the proposed research did not represent a significant and innovative continuation of our research program. The proposed research was viewed as duplicative and confirmatory. Given this, the reviewers were disappointed we did not propose an intervention. (Parenthetically, we should note an intervention study would require a budget that would far exceed the budget limits placed on competing continuations per NIH policy (Le., 120% of current budget.» After much careful consideration and discussion of these 2 fundamental concerns, we decided the observational study proposed in the original application _do_e_s constitute an innovative, significant, and scientifically meritorious extension of our research program. While we completely agree with the reviewers that an intervention study is the ultimate goal of our program of research, we respectfully disagree with the reviewers' conclusion that an intervention study constitutes the _ne_xt_logical step in our research program. We recognize by rejecting the suggested intervention study, we risk alienating the reviewers right from the get-go. However, we decided an equally justifiable course of action was to do a much better job in the application of highlighting the significance, innovation, and importance of our observational study. We made this decision with some trepidation, of course, but we trust the reviewers will consider carefully the merits of our argument.