Response to Reviewer Comments
Reviewer 1, Comment 1: "The problem statement lacks sufficient contemporary epidemiological data for the target population, making the proposed intervention's urgency unclear."
Response: We acknowledge the reviewer's comment regarding the need for more current epidemiological data to underscore the urgency of the proposed intervention. In response, we have revised the Problem Statement (pages 3-4) to incorporate recently published national and regional epidemiological statistics from the CDC and local health authority reports (2022-2023 data). These updates demonstrate a significant and growing prevalence of the target condition within our service area, particularly among the demographic groups identified for the intervention. Specifically, the revised text now highlights a 15% increase in diagnosis rates over the past three years, directly affirming the critical and time-sensitive need for the proposed preventative strategy.
Reviewer 1, Comment 2: "The proposed sample size (N=50) for the pilot study seems insufficient to detect meaningful differences given the primary outcome's expected variability."
Response: We appreciate the reviewer's concern regarding the adequacy of the pilot study's sample size. We agree that the initial N=50 may limit our ability to detect statistically significant preliminary effects for the primary outcome. Therefore, we have increased the proposed sample size to N=80 for the pilot study. This adjustment is justified by a revised power calculation, detailed in the Approach/Methodology section (pages 12-13), which now assumes a more conservative effect size based on recent literature in similar populations. The increased sample size provides 80% power to detect a 0.3 standard deviation difference in our primary outcome measure (reduction in symptom severity score) at an alpha of 0.05, enhancing the feasibility of observing meaningful trends to inform a subsequent larger-scale trial.
Reviewer 2, Comment 1: "The budget narrative for personnel doesn't clearly justify the 0.5 FTE for a dedicated data analyst, especially for a pilot."
Response: We thank the reviewer for pointing out the need for clearer justification for the data analyst FTE. Upon re-evaluation, we recognize that a 0.5 FTE for a dedicated data analyst might be excessive for the pilot phase. We have revised the Budget Narrative (page 20) and associated justification to reflect a reduced allocation of 0.25 FTE for the data analyst position. This adjustment is based on a refined scope of work for the pilot, focusing primarily on data cleaning, preliminary descriptive statistics, and basic inferential analyses, which can be adequately managed within a quarter-time commitment. The revised justification now explicitly details the specific tasks and estimated hours for the analyst, ensuring that the resource allocation is both appropriate for the pilot's scope and fiscally responsible.