PHLT 8046 Week 10 Resubmission Response to Review Example

Introduction to the Resubmission: Answering Three Concerns From the Panel's Summary Statement on the HEPA Air Cleaner Trial With Revisions Located in the Revised Application

Student Name

Walden University

PHLT 8046: Grant Writing and Review for Public Health Research

Instructor Name

Month Day, Year

Introduction to the Resubmission: Answering Three Concerns From the Panel's Summary Statement on the HEPA Air Cleaner Trial With Revisions Located in the Revised Application

Introduction to the Resubmission

We thank the reviewers for a thorough and constructive critique. The panel judged the question important and the sham-controlled design appropriate, and raised three principal concerns: that the assumed rate of urgent asthma visits was not supported by data, that the application did not show families would run the cleaners when smoke arrived, and that the definition of smoke events and the handling of exposure outside the home were underspecified. We have revised the application to address each concern. Changes in the Research Strategy are marked with a vertical line in the margin, and each response below gives the location of the revised text.

Concern 1: The Event Rate Underlying the Power Calculation

Reviewers noted that the assumed 1.6 urgent visits per child over two fire seasons was drawn from a general pediatric asthma estimate and might not apply to the enrolled population. We agree that the assumption needed local support. We obtained de-identified claims from both Medicaid plans for the 2022 through 2024 fire seasons and applied our eligibility criteria. Among children with persistent asthma and an urgent visit in the prior year, the mean was 1.7 urgent asthma visits per child across two consecutive fire seasons, with overdispersion similar to our original assumption. The revised power calculation, now based on these data, retains 80% power for a rate ratio of 0.70 with 150 children per arm. The protocol now also names the backup cohort from the adjacent county, triggered if the observed sham-arm rate falls below 1.2 visits per child midway through the first season (Approach, Aim 2, Analysis and Power, and Potential Problems).

Concern 2: Whether Families Will Run the Cleaners

Reviewers asked how the team would know whether a null result reflected an ineffective intervention or one that was not used, and whether families might guess their assignment. We have made three changes. First, smoke-day use, already recorded by the runtime meters in both arms, is now a prespecified secondary outcome and a covariate in a per-protocol analysis (Approach, Aim 3, Measures). Second, we completed a pilot in 12 homes during the 2024 season, in which families ran units on 78% of smoke days and named noise at night as the main reason for switching off; the revised protocol therefore selects a model rated below 40 decibels at its overnight setting (Approach, Randomization, Masking and Intervention). Third, families will be asked at the end of follow-up to guess their assignment, allowing us to assess and report the success of masking (Approach, Rigor).

Concern 3: Defining Smoke Events and Exposure Outside the Home

Reviewers asked whether requiring both a satellite plume and a monitor reading above 35.4 micrograms per cubic meter would miss lighter smoke days that still harm children with asthma, and noted that children spend much of the day outside their bedrooms. We retain the combined definition for the primary analysis, since pairing plume data with monitor readings separates wildfire smoke from other pollution (Henderson et al., 2011), and add a prespecified sensitivity definition that counts plume days with readings above 12.0 (Approach, Defining Smoke Events). To address exposure elsewhere, the revised protocol adds a brief time-activity question sent by text message on smoke days, asking where the child spent most of the day, and we will use responses as a covariate and to examine whether effects are larger among children who stayed home (Approach, Aim 2, Analysis). We acknowledge in the revised limitations that the trial tests a bedroom intervention, not total exposure reduction, and that its results apply to that use case.

Summary of Revisions

These revisions strengthen the trial's rigor without changing its question or primary outcome. The pilot data on use and the local event rates, in particular, address the feasibility concerns that most limited the original score, and they rest on the same field procedures the full trial will use, consistent with the field evidence that cleaner performance depends on how homes are built and units are run (Xiang et al., 2021). Our design and its rationale continue to respond to the gap the panel recognized, whether filtered bedroom air on smoky days actually keeps children out of urgent care (Lanphear et al., 2011).

Table 1

Panel Concerns, Revisions and Their Locations

Note. Revised passages are marked in the margin of the Research Strategy as the funder's resubmission instructions require.

References

Henderson, S. B., Brauer, M., MacNab, Y. C., & Kennedy, S. M. (2011). Three measures of forest fire smoke exposure and their associations with respiratory and cardiovascular health outcomes in a population-based cohort. Environmental Health Perspectives, 119(9), 1266-1271. https://doi.org/10.1289/ehp.1002288

Lanphear, B. P., Hornung, R. W., Khoury, J., Yolton, K., Lierl, M., & Kalkbrenner, A. (2011). Effects of HEPA air cleaners on unscheduled asthma visits and asthma symptoms for children exposed to secondhand tobacco smoke. Pediatrics, 127(1), 93-101. https://doi.org/10.1542/peds.2009-2312

Xiang, J., Huang, C.-H., Shirai, J., Liu, Y., Carmona, N., Zuidema, C., Austin, E., Gould, T., Larson, T., & Seto, E. (2021). Field measurements of PM2.5 infiltration factor and portable air cleaner effectiveness during wildfire episodes in US residences. Science of the Total Environment, 773, Article 145642. https://doi.org/10.1016/j.scitotenv.2021.145642