PU555 Unit 10 Research Proposal Example

Two Aims, One Question Nine Units Built: A Unit 10 Research Proposal on the Adults Whose Laboratory Results Show Kidney Disease and Who Have Never Heard the Diagnosis, Pairing a Pooled National Analysis With Twenty Interviews

[Student Name]

Purdue University Global

PU555: Foundations of Public Health Research

Unit 10 Research Proposal

[Instructor Name]

[Date]

The composite health center and the budget are invented; the data sources, the methods and the research cited are real.

Background and the Gap

Reduced kidney function is common, progressive and largely silent, and the people who have it frequently do not know. In national survey data, under a tenth of adults in the middle stages said anyone had told them, and the figure climbs only as the kidneys approach failure (Plantinga et al., 2008). Awareness also varies with markers beyond the filtration value itself, so two patients holding the same laboratory result can stand in very different relationships to a diagnosis (Tuot et al., 2011). A synthesis across studies and settings found the estimate depends heavily on how the question is asked, and that the patient-facing question has rarely been paired with any account of what was said to them (Chu et al., 2021). That pairing is the gap this study addresses.

Aim One, and Its Method

Estimate the proportion of adults aged 20 and over with estimated filtration between 30 and 59 who report ever having been told they have kidney trouble, and compare it between those who report a usual place of care and those who do not.

1. Design: secondary analysis of a national examination survey, cycles pooled.

2. Measures: filtration from measured serum creatinine through the 2021 race-free equation (Inker et al., 2021); awareness from the survey's verbatim item, with refused and do not know retained; usual place of care dichotomized.

3. Analysis: weighted proportions with the survey's design variables, unweighted counts beside every estimate, any cell below 30 observations flagged, and a stratified comparison rather than a single pooled figure.

4. What it cannot do: establish that regular care causes awareness, since the design is cross-sectional and the two groups differ in ways no adjustment removes.

Aim Two, and Its Method

Describe what adults with reduced function recall being told, in what words, by whom, and what they did afterward.

1. Design: 20 semi-structured interviews, 45 minutes, recorded with permission, from one composite community health center.

2. Sampling: purposive from the center's own laboratory results, aiming for variation in filtration band, age, language and whether the chart carries a kidney diagnosis.

3. Recruitment: introduction by the patient's own clinician, permission to contact only, team contact after 48 hours, consent taken by the team, as set out in the review board draft from Unit 7.

4. Analysis: thematic coding by two coders with a written framework, disagreements resolved by discussion and recorded, with the advisory group reviewing themes before interpretation is written.

The first aim counts the gap. The second asks the people inside it what happened, which is the part no file contains.

Why Two Aims Rather Than One

A proportion without an account describes a failure and points nowhere, which was the objection a classmate raised in Unit 1 and the reason the proposal grew a second aim. An interview study without a denominator cannot say whether it found something common or something rare. The two aims answer different questions and are reported as two results rather than mixed into one narrative, and the proposal states plainly that the interview participants are not a sample of the survey population.

What Each Earlier Unit Contributed

The question's three checkable terms came from the Unit 2 memo, which also rejected the word adequate. The evidence base came from the Unit 3 search log, 19 records with every exclusion written down. The Unit 4 source review assigned roles to four data sources and ruled out two of them. The Unit 5 seminar removed the chart proxy that the first design had relied on. The Unit 6 ethics case produced the publication term now written into the engagement plan. Unit 7 produced the consent and risk sections. Unit 8 produced the advisory group that rewrote the question. Unit 9 produced the operational definitions, including the equation decision that changes the denominator.

Ethics and Engagement

Review board approval is sought for the interview aim; the survey analysis uses a public de-identified file and is submitted for a determination rather than full review. Participants receive 40 dollars, and the center holds two follow-up appointment slots a week for anyone who learns something during an interview. No neighborhood, clinic or congregation is named in any publication without agreement, which is the term the Unit 6 case made necessary. The advisory group is paid, meets six times, and sees draft interpretation before submission, which locates this study as consultative rather than community-led (Key et al., 2019).

Budget and Timeline

Fourteen months. Months 1 to 3, approvals and advisory group meetings one and two. Months 3 to 6, survey analysis. Months 5 to 11, interviews, with recruitment paused twice for advisory review. Months 11 to 13, coding and interpretation sessions. Month 14, writing. Direct costs: 800 dollars in participant payments, 3,600 dollars in advisory payments plus transport, 2,400 dollars transcription, 1,200 dollars bilingual interviewer time, no data purchase. Total under 9,000 dollars, which is the budget the Unit 1 post argued should be spent on this question rather than on an underpowered supplement trial.

What Would Make This Study Not Worth Doing

Three conditions would retire the question, and naming them is part of proposing it. If a current national estimate showed awareness above roughly half in this band, the gap would be narrow enough that the interviews would be the whole study and the analysis would add little. If a large health system published an audit of what patients are told, with the conversation recorded rather than inferred, the second aim would be answered better than twenty interviews can answer it. And if the survey's awareness item were retired or reworded mid-study, the pooled estimate would lose its comparability and the first aim would have to be rebuilt around a different file. The proposal commits to checking the first two before analysis begins and the third before cycles are pooled.

Limitations, Written Before the Results

The awareness item sets a high linguistic bar and may undercount people who were told in gentler words. The interviews come from one clinic in one county and will not generalize. Recall is the outcome, not clinician speech, and the study cannot distinguish a conversation that never happened from one the patient does not remember, which is the question the Unit 5 seminar group could not settle either. And because the filtration equation changed in 2021, the denominator here is not identical to the one behind the older published estimates, so this study's proportion should be compared with them cautiously (Delgado et al., 2022).

References

Chu, C. D., Chen, M. H., McCulloch, C. E., Powe, N. R., Estrella, M. M., Shlipak, M. G., & Tuot, D. S. (2021). Patient awareness of CKD: A systematic review and meta-analysis of patient-oriented questions and study setting. Kidney Medicine, 3(4), 576-585. https://doi.org/10.1016/j.xkme.2021.03.014

Delgado, C., Baweja, M., Crews, D. C., Eneanya, N. D., Gadegbeku, C. A., Inker, L. A., Mendu, M. L., Miller, W. G., Moxey-Mims, M. M., Roberts, G. V., St Peter, W. L., Warfield, C., & Powe, N. R. (2022). A unifying approach for GFR estimation: Recommendations of the NKF-ASN Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Disease. American Journal of Kidney Diseases, 79(2), 268-288. https://doi.org/10.1053/j.ajkd.2021.08.003

Inker, L. A., Eneanya, N. D., Coresh, J., Tighiouart, H., Wang, D., Sang, Y., Crews, D. C., Doria, A., Estrella, M. M., Froissart, M., Grams, M. E., Greene, T., Grubb, A., Gudnason, V., Gutierrez, O. M., Kalil, R., Karger, A. B., Mauer, M., Navis, G., ... Levey, A. S. (2021). New creatinine- and cystatin C-based equations to estimate GFR without race. The New England Journal of Medicine, 385(19), 1737-1749. https://doi.org/10.1056/NEJMoa2102953

Key, K. D., Furr-Holden, D., Lewis, E. Y., Cunningham, R., Zimmerman, M. A., Johnson-Lawrence, V., & Selig, S. (2019). The continuum of community engagement in research: A roadmap for understanding and assessing progress. Progress in Community Health Partnerships, 13(4), 427-434. https://doi.org/10.1353/cpr.2019.0064

Plantinga, L. C., Boulware, L. E., Coresh, J., Stevens, L. A., Miller, E. R., Saran, R., Messer, K. L., Levey, A. S., & Powe, N. R. (2008). Patient awareness of chronic kidney disease: Trends and predictors. Archives of Internal Medicine, 168(20), 2268-2275. https://doi.org/10.1001/archinte.168.20.2268

Tuot, D. S., Plantinga, L. C., Hsu, C. Y., Jordan, R., Burrows, N. R., Hedgeman, E., Yee, J., Saran, R., & Powe, N. R. (2011). Chronic kidney disease awareness among individuals with clinical markers of kidney dysfunction. Clinical Journal of the American Society of Nephrology, 6(8), 1838-1844. https://doi.org/10.2215/CJN.00730111