Document is current

Article History

Received: 3 May 2024

Accepted: 18 December 2024

First Online: 28 December 2024

Declarations

:

: The use of a nasal swab to test for MRSA is minimal risk, as a nasal swab is not considered an invasive test and is currently used in routine care. Patients in the ICU receive twice daily nasal swabs for nasal decolonization while in the ICU as part of routine clinical practice. The risk to patients from the nasal swabs to detect MRSA is less than the risk from the routine nasal decolonization swabs as the swabs for MRSA detection do not contain any drugs. These routine nasal decolonization swabs are done as part of regular care without written consent from patients. Patients will have the same rights to refuse nasal MRSA swabs as their ability to refuse the routine nasal decolonization. In addition, this study does not make any decisions regarding the treatments offered to patients. Instead, it only provides information and antimicrobial stewardship guidance to patient’s providers who retain complete autonomy over what is the appropriate care for their patients.In addition to the minimal risk posed by the study, obtaining informed consent prior to enrollment in this study would not be feasible or practicable for multiple reasons:1) The potential benefit of MRSA screening is dependent on early, rapid testing to generate results that are readily available to help guide the providers’ decisions. This means that the swab must be ordered immediately at the time that the ICU provider decides to start or continue antibiotics, and prior to routine decolonization that is performed in all patients admitted to the ICUs at Vanderbilt University Medical Center. This event typically occurs simultaneously with a patient’s arrival to the ICU. If the decision to obtain a MRSA nasal swab is delayed until written consent is acquired, it would be too late to study its effect.2) The MRSA nasal swabs are only considered valid if they are collected prior to nasal decolonization. Since nasal decolonization with the use of nasal swabs occurs regularly twice a day in all ICU patients at VUMC, and most critically ill patients are temporarily cognitively impaired due to their critical illness upon entry to the ICU, it would not be possible to obtain written consent prior to decolonization in most cases.3) The goal of the study is to test whether the use of a MRSA nasal swab would reduce the length of time that patients receive unnecessary antibiotics; thus, it must be done at the same time that the decision to start or continue antibiotics is made. Since the use of antibiotics in the ICU is an urgent intervention in many patients, it would be inappropriate and likely detrimental to delay the receipt of antibiotics in some of the most critically ill patients in order to get written consent for either the MRSA nasal swab or participation in the study.4) The decision to initiate antibiotics is often made when patients are critically ill and unable to consent for themselves; therefore, it would often not be feasible to obtain consent from a patient or their representative at the time at which the MRSA nasal swab would need to be performed.5) Consenting the participants may prompt either the clinical team or the participant to order (or ask for) the MRSA nasal swab in patients randomized to the control arm (and thus, randomized not to receive the nasal swab prior to decolonization). This would potentially lead the clinical team to order the MRSA nasal swab prior to decolonization in the control arm as well, which would not allow the study team to truly evaluate the role of an admission MRSA nasal swab in reducing vancomycin use. This contamination of the control arm would bias the study results to not being able to see the effect of the use of these pre-decolonization MRSA nasal swabs on vancomycin use.For these reasons collectively, this study could not be done practicably without a waiver of consent, and it would be impractical to obtain written informed consent. Therefore, given that this study presents minimal risk, it would not adversely affect the welfare or privacy rights of the participant, and it would be impracticable to obtain consent, a waiver of informed consent was requested and approved for this study. Additionally, while the topic of potential retrospective notification is too complex to delve into detail here, retrospective notification was felt to not be appropriate for this trial due to potentially increasing Hawthorne effect and changing clinical practice in the control arm. In addition, patients in the intervention arm will be notified by their providers if the results of the nasal swab result in a change in the care of the patient (i.e., stopping vancomycin).

: Not applicable.

: The authors declare that they have no competing interests.