NR 505 Week 7 Stepped-Wedge Trial Ethics Analysis Example

Ethics of a Stepped-Wedge Trial That Stops Gastric Residual Checks Across Six ICUs: Whether Equipoise Survives Reignier, Consent When the Unit Changes and the Patient Cannot Speak, and What Withdrawal Can Reach

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College of Nursing, Chamberlain University

NR 505: Advanced Research Methods: Evidence-Based Practice

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Month Day, Year

Ethics of a Stepped-Wedge Trial That Stops Gastric Residual Checks Across Six ICUs: Whether Equipoise Survives Reignier, Consent When the Unit Changes and the Patient Cannot Speak, and What Withdrawal Can Reach

The Protocol Before the Principle

The protocol under analysis is the one I proposed in Week 3. Six ICUs in my health system begin with the current routine: gastric residual checks every four hours, with feeds held for residuals over 250 mL. Every two months, one ICU, chosen at random, switches to no routine residual checks, with intolerance judged by vomiting or regurgitation. By month twelve, all six have switched. The outcomes are the percentage of prescribed calories delivered and ventilator-associated pneumonia over each patient's first seven days of tube feeding, taken from the medical record. Patients are ventilated adults, most of them sedated and unable to make decisions for themselves.

Each design decision in that paragraph raises its own ethical question. This analysis takes them in the order they appear in the protocol, rather than working through principles in the abstract, because a different design would raise different questions.

Randomization and Equipoise

Randomizing units to a practice is defensible only while there is genuine uncertainty about which practice is better. Freedman (1987) described this as clinical equipoise: honest professional disagreement among expert clinicians about the preferred treatment, rather than the uncertainty of a single investigator. The question for my protocol is whether that disagreement still exists.

The case that it does not is strong. Reignier et al. (2013) found no increase in pneumonia without residual monitoring and better calorie delivery, and the major U.S. critical care nutrition guideline advises against routine residual monitoring (McClave et al., 2016). If the evidence settled the question, then keeping any ICU on the old routine for up to twelve months, to serve as a comparison, would mean knowingly withholding a better practice.

The case that equipoise survives rests on the specific question. The French trial excluded patients in the prone position, and my unit places many ventilated patients in the prone position. The trial used six-hourly checks, not four-hourly ones. And a smaller 2026 trial of once-daily checks found more feeding intolerance with less monitoring, though its result was inconclusive rather than harmful (Zhang et al., 2026). Among the ICU nurses and physicians in my system, opinion is genuinely divided. I conclude that equipoise exists for this population and this comparison, but narrowly, and that the protocol should say why in its application to the ethics board. The stepped-wedge design also helps: no ICU is kept on the old routine permanently, and every patient in the later periods receives the new practice.

Consent When the Unit Changes

Individual consent is the hardest question. The intervention is a unit-level policy, carried out by every nurse for every patient on a switched unit. A patient on a switched unit cannot receive the old routine without the unit running two practices at once, which is what the stepped-wedge design was chosen to avoid. And most patients cannot consent because they are sedated.

The Ottawa Statement on cluster randomized trials addresses this situation (Weijer et al., 2012). It asks researchers to identify who the research participants are, and it allows an ethics board to waive or alter consent when the research would not be feasible with it and when the interventions pose no more than minimal risk. My protocol meets the feasibility condition. Whether it meets the risk condition is exactly the equipoise question above. The approach I would propose is that the policy change itself proceeds without individual consent, because it is a change in unit practice made within the range of accepted care, while the use of each patient's record data for the research is disclosed to the surrogate, who can decline it.

Payment and Undue Influence

The protocol offers no payment to patients or families, and it should not. Payment raises a concern about undue influence when an amount that is a small thank-you to one person is a significant sum to another, pushing people to accept risks they otherwise would not. In an ICU, the concern is sharper: families are frightened, exhausted and often facing unexpected costs, and an offer of money at the bedside would be hard to separate from pressure.

The influence in this protocol comes from another direction. Families trust the nurses at the bedside, and a nurse who explains the study may be heard as recommending it. The protocol should have data disclosures made by a research coordinator, not the patient's own nurse, and should state that declining will not change the patient's care in any way. Given the design, it cannot, and saying so plainly is part of honest disclosure.

What a Board Is Protecting

An ethics board reviewing this protocol is protecting three groups. It protects the patients, most obviously from being fed less well or harmed by pneumonia, which the protocol addresses with a data safety monitoring plan that reviews pneumonia rates after each switch. It protects the patients' privacy, since the record data include diagnoses and outcomes. And, less obviously, it protects the nurses, who become participants of a kind when their practice is changed for research. The Ottawa Statement notes that people whose work is altered by a cluster trial may themselves need to be considered (Weijer et al., 2012). Nurses in switched units should be told the study's purpose and should have a way to report concerns about a patient without it being treated as protocol deviation.

Withdrawal, and What It Reaches

A surrogate can withdraw a patient from the research at any time. What withdrawal can reach needs to be stated honestly. It cannot remove the patient from the unit's feeding practice, because the practice applies to everyone on the unit. It can stop the collection of the patient's data from that point, and it can remove any data already collected from the analysis, if the protocol allows it.

Removing data already collected has a cost to the research: patients who withdraw may differ from those who stay, and their absence could bias the results. Reignier et al. (2013) excluded three patients who withdrew consent from their analysis. My protocol would do the same, and the disclosure given to surrogates should say plainly, in a single sentence, that withdrawal stops data use but cannot change the unit's feeding practice for their family member.

References

Freedman, B. (1987). Equipoise and the ethics of clinical research. New England Journal of Medicine, 317(3), 141-145. https://doi.org/10.1056/NEJM198707163170304

McClave, S. A., Taylor, B. E., Martindale, R. G., Warren, M. M., Johnson, D. R., Braunschweig, C., McCarthy, M. S., Davanos, E., Rice, T. W., Cresci, G. A., Gervasio, J. M., Sacks, G. S., Roberts, P. R., & Compher, C. (2016). Guidelines for the provision and assessment of nutrition support therapy in the adult critically ill patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). Journal of Parenteral and Enteral Nutrition, 40(2), 159-211. https://doi.org/10.1177/0148607115621863

Reignier, J., Mercier, E., Le Gouge, A., Boulain, T., Desachy, A., Bellec, F., Clavel, M., Frat, J.-P., Plantefeve, G., Quenot, J.-P., & Lascarrou, J.-B. (2013). Effect of not monitoring residual gastric volume on risk of ventilator-associated pneumonia in adults receiving mechanical ventilation and early enteral feeding: A randomized controlled trial. JAMA, 309(3), 249-256. https://doi.org/10.1001/jama.2012.196377

Weijer, C., Grimshaw, J. M., Eccles, M. P., McRae, A. D., White, A., Brehaut, J. C., & Taljaard, M. (2012). The Ottawa statement on the ethical design and conduct of cluster randomized trials. PLoS Medicine, 9(11), Article e1001346. https://doi.org/10.1371/journal.pmed.1001346

Zhang, H., Chen, Y., Li, F., He, C., Li, X., Wang, Y., Fan, J., Wang, J., Xia, Y., Guo, N., & Yu, K. (2026). Efficacy and tolerability of non-routine gastric residual volume monitoring in mechanically ventilated adults receiving early enteral nutrition: A randomised controlled non-inferiority trial. Nursing in Critical Care, 31(3), Article e70486. https://doi.org/10.1111/nicc.70486